- Saturday, September 10, 2022
6:30 AM – 10:00 AM MST
Speaker Ready Room Open
6:30 AM – 10:00 AM MST
Speaker Ready Room Open
Location/Room:W202
6:30 AM – 1:00 PM MST
Registration Open
6:30 AM – 1:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 8:00 AM MST
Preconference Workshops: Breakfast
7:00 AM – 8:00 AM MST
Preconference Workshops: Breakfast
Location/Room:Session Rooms: W101-106 Foyers
7:00 AM – 5:00 PM MST
First Aid Services
7:00 AM – 5:00 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
8:00 AM – 8:30 AM MST
Preconference Workshops: Welcome
8:00 AM – 8:30 AM MST
Preconference Workshops: WelcomeLocation/Room:Session Rooms: W101-106 FoyersPresenter: – Velvet Chainsaw Consulting
Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Presenter###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Presenter: – Velvet Chainsaw Consulting
### 8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership (Day 1 of 2)
8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership (Day 1 of 2)Location/Room:W102 A-CWorkshop Leader: – COPIA Coaching and Consulting
Carol Robert, MA, PCC, PMP, CDTLF – COPIA Coaching and Consulting ### 1699441###Workshop Leader###Associate###COPIA Coaching and Consulting###Workshop Leader: – COPIA Coaching and Consulting
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI program from Scratch
8:30 AM – 4:00 PM MST
Preconference Workshop: Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI Program from ScratchLocation/Room:W103 A-BWorkshop Leader: – Seagen Inc.
Biopharmaceuticals
Chris Whalley – Seagen Inc. ### 1000102###Workshop Leader###Associate Director, Regulatory Policy & Intelligence###Seagen Inc.###Workshop Leader: – Seagen Inc.
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Clinical Evaluation
8:30 AM – 4:00 PM MST
Preconference Workshop: Clinical EvaluationLocation/Room:W101 A-BWorkshop Leader: – Qserve Group
Speaker: – Qserve Group
Medical Devices
Mindy McCann – Qserve Group ### 720640###Workshop Leader###VP Regulatory Compliance###Qserve Group###Workshop Leader: – Qserve Group
### @@@ Patrícia da Silva Peres, PhD – Qserve Group ### 1755603###Speaker###Consultant###Qserve Group###Speaker: – Qserve Group
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Drug Development in EU: Regulatory Standards, Support and New Approaches
8:30 AM – 4:00 PM MST
Preconference Workshop: Drug Development in EU: Regulatory Standards, Support and New ApproachesLocation/Room:W104 A-BSpeaker: – Austrian Medicines and Medical Devices Agency
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker (Remote): – Spanish Agency for Medicines and Medical Devices
Speaker: – European Medicines Agency
Speaker: – MDC RegAffairs GmbH
Speaker: – Malta Medicines Authority
Speaker (Remote): – Norwegian Medicines Agency
Biopharmaceuticals
Andrea Laslop, Prof, MD – Austrian Medicines and Medical Devices Agency ### 573431###Speaker###Head of Scientific Office, Federal Office for Safety in Health Care###Austrian Medicines and Medical Devices Agency###Speaker: – Austrian Medicines and Medical Devices Agency
### @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###Speaker: – AGES (Austrian Agency for Health & Food Safety)
### @@@ Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices ### 790292###Speaker (Remote)###Representative from Spain at the CHMP (EMA)###Spanish Agency for Medicines and Medical Devices###Speaker (Remote): – Spanish Agency for Medicines and Medical Devices
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Matthias Dormeyer, MD – MDC RegAffairs GmbH ### 573390###Speaker###Managing Director###MDC RegAffairs GmbH###Speaker: – MDC RegAffairs GmbH
### @@@ John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority ### 1757708###Speaker###Post-Licensing Director###Malta Medicines Authority###Speaker: – Malta Medicines Authority
### @@@ Anja E. Schiel, PhD, Senior Advisor – Norwegian Medicines Agency ### 1773211###Speaker (Remote)###Lead Methodologist in Regulatory and Pharmacoeconomic Statistics###Norwegian Medicines Agency###Speaker (Remote): – Norwegian Medicines Agency
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Strategic and Innovative Thinking for Regulatory Professionals - Principles and Practical Guidance
8:30 AM – 4:00 PM MST
Preconference Workshop: Strategic and Innovative Thinking for Regulatory Professionals - Principles and Practical GuidanceLocation/Room:W101 CWorkshop Leader: – Pearl Meyer Consulting
Broad Interest
Elise Walton, MA, PhD – Pearl Meyer Consulting ### 1718918###Workshop Leader###Principal of Veritas Partners###Pearl Meyer Consulting###Workshop Leader: – Pearl Meyer Consulting
###
8:30 AM – 4:00 PM MST
Preconference Workshop: US Regulatory Essentials - Medical Devices and IVDs
8:30 AM – 4:00 PM MST
Preconference Workshop: US Regulatory Essentials - Medical Devices and IVDsLocation/Room:W106 A-BWorkshop Leader: – Cook Medical
Speaker: – Cook Medical
Speaker: – Cook Incorporated
Speaker: – DuVal & Associates, P.A.
Speaker (Remote): – AtriCure, Inc.
Speaker: – Greenlight Guru
Speaker: – Greenlight Guru
Session Leader/Speaker (Remote): – Qserve Group
David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Workshop Leader###Director, Regulatory Affairs / Regulatory Science###Cook Medical###Workshop Leader: – Cook Medical
### @@@ Andrea Gadsby – Cook Medical ### 1397976###Speaker###Quality Director, Cook Incorporated###Cook Medical###Speaker: – Cook Medical
### @@@ Larry Pool – Cook Incorporated ### 1397977###Speaker###Dir, Post Market###Cook Incorporated###Speaker: – Cook Incorporated
### @@@ Mark DuVal, J.D., FRAPS – DuVal & Associates, P.A. ### 535473###Speaker###President & CEO,###DuVal & Associates, P.A.###Speaker: – DuVal & Associates, P.A.
### @@@ Tony Blank – AtriCure, Inc. ### 1036809###Speaker (Remote)###Senior Director, Regulatory Affairs###AtriCure, Inc.###Speaker (Remote): – AtriCure, Inc.
### @@@ Etienne Nichols, PMP, CSM – Greenlight Guru ### 1397975###Speaker###Medical Device Guru###Greenlight Guru###Speaker: – Greenlight Guru
### @@@ Laura Court – Greenlight Guru ### 1605904###Speaker###Medical Device Guru###Greenlight Guru###Speaker: – Greenlight Guru
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Session Leader/Speaker (Remote)###Principal Consultant, QA/RA and IVD Expert###Qserve Group###Session Leader/Speaker (Remote): – Qserve Group
###
8:30 AM – 5:00 PM MST
Press Room
8:30 AM – 5:00 PM MST
Press Room
Location/Room:W203
10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
Location/Room:Session Rooms: W101-106 Foyers
12:30 PM – 1:30 PM MST
Preconference Workshops: Lunch
12:30 PM – 1:30 PM MST
Preconference Workshops: Lunch
Location/Room:Session Rooms: W101-106 Foyers
- Sunday, September 11, 2022
6:30 AM – 4:00 PM MST
Speaker Ready Room Open
6:30 AM – 4:00 PM MST
Speaker Ready Room Open
Location/Room:W202
6:30 AM – 7:00 PM MST
Registration Open
6:30 AM – 7:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 8:00 AM MST
Preconference Workshops: Breakfast
7:00 AM – 8:00 AM MST
Preconference Workshops: BreakfastLocation/Room:Session Rooms: W101-106 Foyers
7:00 AM – 7:30 PM MST
First Aid Services
7:00 AM – 7:30 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
8:00 AM – 8:30 AM MST
Preconference Workshops: Welcome
8:00 AM – 8:30 AM MST
Preconference Workshops: WelcomeLocation/Room:Session Rooms: W101-106 FoyersPresenter: – Velvet Chainsaw Consulting
Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Presenter###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Presenter: – Velvet Chainsaw Consulting
### 8:30 AM – 4:00 PM MST
Preconference Workshop: 5 Ways to Improve Your EU MDR Submission Now: What do the Experts Say?
8:30 AM – 4:00 PM MST
Preconference Workshop: 5 Ways to Improve Your EU MDR Submission Now: What Do the Experts Say?Location/Room:W106 A-BSpeaker: – Global Strategic Solutions, LLC
Speaker: – Strategic Business Development at TÜV SÜD
Speaker: – (British Standards Institute) BSI
Medical Devices
David R. Rutledge, PharmD – Global Strategic Solutions, LLC ### 585117###Speaker###President & CEO###Global Strategic Solutions, LLC###Speaker: – Global Strategic Solutions, LLC
### @@@ Martin Witte – Strategic Business Development at TÜV SÜD ### 1187576###Speaker###Senior Director###Strategic Business Development at TÜV SÜD ###Speaker: – Strategic Business Development at TÜV SÜD
### @@@ Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI ### 1054191###Speaker###Global Head of Clinical Compliance/Clinical Physiologist###(British Standards Institute) BSI###Speaker: – (British Standards Institute) BSI
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership Workshop (Day 2 of 2)
8:30 AM – 4:00 PM MST
Preconference Workshop: Advanced Leadership Workshop (Day 2 of 2)Location/Room:W102 A-CWorkshop Leader: – COPIA Coaching and Consulting
Carol Robert, MA, PCC, PMP, CDTLF – COPIA Coaching and Consulting ### 1699441###Workshop Leader###Associate###COPIA Coaching and Consulting###Workshop Leader: – COPIA Coaching and Consulting
### 8:30 AM – 4:00 PM MST
Preconference Workshop: Digital Therapeutics (DTx) - Introductory Overview of a Fast-Growing (Yet Sometimes Nebulous) Class of Treatments
8:30 AM – 4:00 PM MST
Preconference Workshop: Digital Therapeutics (DTx) - Introductory Overview of a Fast-growing (Yet Sometimes Nebulous) Class of TreatmentsLocation/Room:W101 A-BSpeaker: – Orthogonal
Speaker: – Twill
Guest Speaker: – HabitNu
Guest Speaker: – Mckesson
Guest Speaker: – Cognito Therapeutics, Inc.
Guest Speaker: – Biogen Digital Health (BDH)
Guest Speaker: – MindMaze
Medical Devices
Randy Horton, Master's – Orthogonal ### 1636768###Speaker###VP of Solutions and Partnerships###Orthogonal###Speaker: – Orthogonal
### @@@ Brian Binkowski – Twill ### 1636769###Speaker###Director of Quality###Twill###Speaker: – Twill
### @@@ Sindhu Rajan, PhD – HabitNu ### 1773248###Guest Speaker###CEO###HabitNu###Guest Speaker: – HabitNu
### @@@ Ethan Wergelis-Isaacson – Mckesson ### 1773249###Guest Speaker###Director, Strategy and BD ###Mckesson###Guest Speaker: – Mckesson
### @@@ Jennifer Newberger, JD, MPH – Cognito Therapeutics, Inc. ### 1773251###Guest Speaker###VP, Regulatory and Compliance###Cognito Therapeutics, Inc.###Guest Speaker: – Cognito Therapeutics, Inc.
### @@@ Krystyna Zaluski, MA – Biogen Digital Health (BDH) ### 1773252###Guest Speaker###Global Lead - Digital Solutions for Mental Health###Biogen Digital Health (BDH)###Guest Speaker: – Biogen Digital Health (BDH)
### @@@ Gaurav Gupta, CFA – MindMaze ### 1773254###Guest Speaker###Director###MindMaze###Guest Speaker: – MindMaze
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Global Drug Development for Rare and Orphan Diseases
8:30 AM – 4:00 PM MST
Preconference Workshop: Global Drug Development for Rare and Orphan DiseasesLocation/Room:W104 A-BWorkshop Leader: – Just-Evotec, Biologics
Workshop Leader (Remote): – Novo Nordisk
Biopharmaceuticals
Sundar Ramanan, PhD, MBA – Just-Evotec, Biologics ### 1668301###Workshop Leader###SVP, Global Biotherapeutics Quality###Just-Evotec, Biologics###Workshop Leader: – Just-Evotec, Biologics
### @@@ Sunny Kamlesh Dave, MPharm – Novo Nordisk ### 1668302###Workshop Leader (Remote)###Regulatory Professional-Rare disease###Novo Nordisk###Workshop Leader (Remote): – Novo Nordisk
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Global Regulatory Strategy for Drugs and Biologics
8:30 AM – 4:00 PM MST
Preconference Workshop: Global Regulatory Strategy for Drugs and BiologicsLocation/Room:W101 CFacilitator: – Agency IQ
Facilitator: – Seagen Inc.
Facilitator: – Rain Therapeutics Inc.
Facilitator: – Moderna, Inc.
Biopharmaceuticals
Kirsten Messmer, PhD, RAC – Agency IQ ### 595312###Facilitator###Senior Research Analyst###Agency IQ###Facilitator: – Agency IQ
### @@@ Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Facilitator###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Facilitator: – Seagen Inc.
### @@@ Tina Kim-Hafken, MS – Rain Therapeutics Inc. ### 1718933###Facilitator###Vice President, Head of Global Regulatory Affairs###Rain Therapeutics Inc.###Facilitator: – Rain Therapeutics Inc.
### @@@ Antonella Lozito-Heerschap, PharmD – Moderna, Inc. ### 1698212###Facilitator###Executive Director, Regulatory Strategy, Infectious Diseases###Moderna, Inc.###Facilitator: – Moderna, Inc.
###
8:30 AM – 4:00 PM MST
Preconference Workshop: Optimize Integrating Human Factors into Your Next Regulatory Submission
8:30 AM – 4:00 PM MST
Preconference Workshop: Optimize Integrating Human Factors into Your Next Regulatory SubmissionLocation/Room:W103 A-BSpeaker: – Agilis Consulting Group
Speaker: – UserWise, Inc.
Speaker: – UserWise, Inc.
Speaker: – Agilis Consulting Group
Medical Devices
Shannon Hoste, MS – Agilis Consulting Group ### 1520068###Speaker###President###Agilis Consulting Group###Speaker: – Agilis Consulting Group
### @@@ Denise Forkey, MS BME – UserWise, Inc. ### 1636764###Speaker###Director, Humans Factors ###UserWise, Inc.###Speaker: – UserWise, Inc.
### @@@ Shannon Clark, PE – UserWise, Inc. ### 1636766###Speaker###CEO###UserWise, Inc. ###Speaker: – UserWise, Inc.
### @@@ Denise Wagner, MS – Agilis Consulting Group ### 1756299###Speaker###Principal Consultant Human Factors Engineering###Agilis Consulting Group###Speaker: – Agilis Consulting Group
### 10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
10:30 AM – 11:00 AM MST
Preconference Workshops: Refreshment Break
Location/Room:Session Rooms: W101-106 Foyers
12:00 PM – 6:30 PM MST
Press Room
12:00 PM – 6:30 PM MST
Press Room
Location/Room:W203
12:00 PM – 6:30 PM MST
RAPS Store
12:00 PM – 6:30 PM MST
RAPS Store
Location/Room:West Hall 1-3 Lobby, Lower Level
12:30 PM – 1:30 PM MST
Preconference Workshops: Lunch
12:30 PM – 1:30 PM MST
Preconference Workshops: LunchLocation/Room:Session Rooms: W101-106 Foyers
2:00 PM – 6:00 PM MST
Mobile App Support Desk
2:00 PM – 6:00 PM MST
Mobile App Support DeskLocation/Room:West Hall 1-3 Lobby, Lower Level
4:30 PM – 6:00 PM MST
Convergence Welcome and Opening Plenary Session
4:30 PM – 6:00 PM MST
Convergence Welcome and Opening Plenary SessionLocation/Room:W301A-DKeynote Speaker (Remote): – Food and Drug Administration
Keynote Speaker (Remote): – European Medicines Agency
Speaker: – XR Association
Speaker: – AFDO/RAPS Healthcare Products Collaborative
Speaker: – Ricoh USA, Inc.
Moderator: – Velvet Chainsaw Consulting
Robert Califf, M.D. – Food and Drug Administration ### 1757582###Keynote Speaker (Remote)###Commissioner###Food and Drug Administration###Keynote Speaker (Remote): – Food and Drug Administration
### @@@ Tony Humphreys, PharmD – European Medicines Agency ### 978348###Keynote Speaker (Remote)###Head Regulatory Science and Innovation Taskforce###European Medicines Agency###Keynote Speaker (Remote): – European Medicines Agency
### @@@ Peirce Clark – XR Association ### 1771087###Speaker###Manager, Program Development###XR Association###Speaker: – XR Association
### @@@ Timothy Hsu – AFDO/RAPS Healthcare Products Collaborative ### 1757583###Speaker###Director of Health Technology Initiatives###AFDO/RAPS Healthcare Products Collaborative###Speaker: – AFDO/RAPS Healthcare Products Collaborative
### @@@ Gary Turner – Ricoh USA, Inc. ### 1762841###Speaker###Managing Director, Additive Manufacturing, North America###Ricoh USA, Inc.###Speaker: – Ricoh USA, Inc.
### @@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Moderator: – Velvet Chainsaw Consulting
###
6:00 PM – 7:30 PM MST
Exhibit Hall Open
6:00 PM – 7:30 PM MST
Exhibit Hall OpenLocation/Room:Exhibit Hall
6:00 PM – 7:30 PM MST
Opening Reception in Exhibit Hall
6:00 PM – 7:30 PM MST
Opening Reception in Exhibit HallLocation/Room:Exhibit Hall
- Monday, September 12, 2022
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check In
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check InLocation/Room:Hyatt Regency Phoenix, Offsite: Hyatt Regency Phoenix Ballroom
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Tennis Ball Massaging
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Tennis Ball MassagingLocation/Room:Hyatt Regency Phoenix, Offsite: Hyatt Regency Phoenix Ballroom
6:30 AM – 6:00 PM MST
Registration Open
6:30 AM – 6:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 5:00 PM MST
Mobile App Support Desk
7:00 AM – 5:00 PM MST
Mobile App Support DeskLocation/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 5:30 PM MST
First Aid Services
7:00 AM – 5:30 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
7:30 AM – 8:45 AM MST
Community Gathering & Continental Breakfast
7:30 AM – 8:45 AM MST
Community Gathering & Continental BreakfastLocation/Room:W301 A-D Lobbies
7:30 AM – 6:00 PM MST
Press Room
7:30 AM – 6:00 PM MST
Press Room
Location/Room:W203
7:30 AM – 6:00 PM MST
RAPS Store Open
7:30 AM – 6:00 PM MST
RAPS Store Open
Location/Room:West Hall 1-3 Lobby, Lower Level
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
Location/Room:W202
8:15 AM – 9:30 AM MST
Morning Plenary Session: Career Transitions
8:15 AM – 9:30 AM MST
Plenary Session: Career TransitionsLocation/Room:W301 A-DSpeaker: – Alexion, AstraZeneca Rare Disease
Speaker: – Bausch + Lomb
Speaker: – MEDIcept Inc.
Speaker: – Seagen Inc.
Moderator: – Velvet Chainsaw Consulting
Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease ### 720625###Speaker###Director, BPO Regulatory & Quality Affairs###Alexion, AstraZeneca Rare Disease###Speaker: – Alexion, AstraZeneca Rare Disease
### @@@ Donielle Johnson – Bausch + Lomb ### 1428960###Speaker###Vice President Global Regulatory Affairs - Medical Devices###Bausch + Lomb###Speaker: – Bausch + Lomb
### @@@ Kimberly A. Trautman, MS – MEDIcept Inc. ### 535494###Speaker###Managing Director and VP###MEDIcept Inc.###Speaker: – MEDIcept Inc.
### @@@ Chris Whalley – Seagen Inc. ### 1000102###Speaker###Associate Director, Regulatory Policy & Intelligence###Seagen Inc.###Speaker: – Seagen Inc.
### @@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Moderator: – Velvet Chainsaw Consulting
### 9:45 AM – 11:00 AM MST
Bridging the Divide: Managing Global Regulatory Interactions During Drug Development
9:45 AM – 11:00 AM MST
Bridging the Divide: Managing Global Regulatory Interactions During Drug DevelopmentLocation/Room:W106 CModerator: – Seagen Inc.
Speaker: – Moderna, Inc.
Speaker: – Alexion Pharmaceuticals Inc.
Speaker: – Rain Therapeutics Inc.
Speaker: – PharmaLex
Biopharmaceuticals
Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Moderator###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Moderator: – Seagen Inc.
### @@@ Antonella Lozito-Heerschap, PharmD – Moderna, Inc. ### 1698212###Speaker###Executive Director, Regulatory Strategy, Infectious Diseases###Moderna, Inc.###Speaker: – Moderna, Inc.
### @@@ Martine Zimmermann, PharmD – Alexion Pharmaceuticals Inc. ### 1452236###Speaker###SVP, Head of Regulatory and R&D and Commercial Quality###Alexion Pharmaceuticals Inc.###Speaker: – Alexion Pharmaceuticals Inc.
### @@@ Tina Kim-Hafken, MS – Rain Therapeutics Inc. ### 1718933###Speaker###Vice President, Head of Global Regulatory Affairs###Rain Therapeutics Inc.###Speaker: – Rain Therapeutics Inc.
### @@@ Patrick Larcier, PharmD – PharmaLex ### 1718947###Speaker###Senior Director, Strategy Product Development Solutions###PharmaLex###Speaker: – PharmaLex
###
9:45 AM – 11:00 AM MST
EU MDR Implementation: Light at the End of the Tunnel?
9:45 AM – 11:00 AM MST
EU MDR Implementation: Light at the End of the Tunnel?Location/Room:W101 A-BSession Leader/Speaker: – Qserve Group
Speaker: – TÜV SÜD Medical Health Services
Speaker: – NAMSA
Medical Devices
Session Room Sponsored By
Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Session Leader/Speaker###CSO - CEO###Qserve Group###Session Leader/Speaker: – Qserve Group
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Speaker: – TÜV SÜD Medical Health Services
### @@@ Kevin Butcher – NAMSA ### 1321698###Speaker###Principal Regulatory Consultant###NAMSA###Speaker: – NAMSA
###
9:45 AM – 11:00 AM MST
Health Authority Forum - Europe
9:45 AM – 11:00 AM MST
Health Authority Forum - EuropeLocation/Room:W105 A-CSession Leader/Speaker: – European Medicines Agency
Speaker: – European Medicines Agency
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker (Remote): – European Medicines Agency
Speaker (Remote): – European Medicines Agency
Health Authority Forum
Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Session Leader/Speaker###Principal Scientific Administrator###European Medicines Agency###Session Leader/Speaker: – European Medicines Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###Speaker: – AGES (Austrian Agency for Health & Food Safety)
### @@@ Ana Hidalgo-Simon, MD, PhD – European Medicines Agency ### 1061460###Speaker (Remote)###Head of Advanced Therapies Office, Human Medicines Division, European Medicines Agency###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Falk Ehmann, MD, PhD, MSc, – European Medicines Agency ### 716669###Speaker (Remote)###Chair Innovation Task Force###European Medicines Agency###Speaker (Remote): – European Medicines Agency
###
9:45 AM – 11:00 AM MST
IVD Clinical Performance Across Geographies
9:45 AM – 11:00 AM MST
IVD Clinical Performance Across GeographiesLocation/Room:W101 CSession Leader/Speaker: – NAMSA
Speaker (Remote): – NAMSA
Speaker (Remote):
In Vitro Diagnostics
Wendy Schroeder, BSN, CCRC, CRCP – NAMSA ### 1344657###Session Leader/Speaker###Principal Product Development Strategist ###NAMSA###Session Leader/Speaker: – NAMSA
### @@@ Zhiping Li, Bachelor – NAMSA ### 1614383###Speaker (Remote)###Clinical Study Manager###NAMSA###Speaker (Remote): – NAMSA
### @@@ Michael Vogl ### 1766932###Speaker (Remote)#########Speaker (Remote):
###
9:45 AM – 11:00 AM MST
Managing Ambiguity: Regulatory Decision Making Under Uncertainties
9:45 AM – 11:00 AM MST
Managing Ambiguity: Regulatory Decision Making Under UncertaintiesLocation/Room:W103 A-BSpeaker: – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
Skill Building
Chyue Yie Chew, RAC (EU & US) – ZP Therapeutics, a Division of Zuellig Pharma ### 1523593###Speaker###Regional Regulatory Affairs Manager###ZP Therapeutics, a Division of Zuellig Pharma###Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
### @@@ Fazlin Azura Azlan, Registered Pharmacist – ZP Therapeutics, a Division of Zuellig Pharma ### 1615667###Speaker###Regional Regulatory Affairs Director###ZP Therapeutics, a Division of Zuellig Pharma###Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
###
9:45 AM – 11:00 AM MST
Patient Preferences in Regulatory Decision Making – A Tipping Point: How the Landmark IMI-PREFER Recommendations & CHMP Methods Qualification Opinion Will Accelerate Your Patient-Centric Drug Development
9:45 AM – 11:00 AM MST
Patient Preferences in Regulatory Decision Making – A Tipping Point: How the Landmark IMI-PREFER Recommendations & CHMP Methods Qualification Opinion Will Accelerate Your Patient-Centric Drug DevelopmentLocation/Room:W106 A-BSession Leader/Speaker: – Eli Lilly and Company
Speaker: – Pfizer, Inc.
Speaker (Remote): – U.S. Food and Drug Administration
Speaker (Remote): – European Medicines Agency
Moderator: – Bayer
Biopharmaceuticals
Session Room Sponsored By
Kristin Bullok, PhD – Eli Lilly and Company ### 720630###Session Leader/Speaker###Global Patient Safety, Benefit-Risk Scientist###Eli Lilly and Company###Session Leader/Speaker: – Eli Lilly and Company
### @@@ Brett Hauber, PhD – Pfizer, Inc. ### 1340363###Speaker###Senior Director, Patient Preference Elicitation###Pfizer, Inc.###Speaker: – Pfizer, Inc.
### @@@ Sara Eggers, PhD – U.S. Food and Drug Administration ### 755508###Speaker (Remote)###Staff Director###U.S. Food and Drug Administration###Speaker (Remote): – U.S. Food and Drug Administration
### @@@ Francesco Pignatti – European Medicines Agency ### 1755903###Speaker (Remote)###Head of Oncology, Haematology, Diagnostics-Safety and Efficacy Sector###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Kim Quaintance-Lunn – Bayer ### 1698208###Moderator###VP, US Regulatory Lead###Bayer###Moderator: – Bayer
###
9:45 AM – 11:00 AM MST
Real-World Evidence for the Real World of Devices: Multinational Regulatory Decision-making
9:45 AM – 11:00 AM MST
Real-World Evidence for the Real World of Devices: Multinational Regulatory Decision-makingLocation/Room:W102 A-CSession Leader/Speaker: – Johns Hopkins Department of Orthopedics/NDA Partners
NDA Partners
Speaker: – Medical Device Innovation Consortium
Speaker: – RAND
Speaker: – BradyKnows Medical, LLC
Medical Devices
Session Room Sponsored By
Stephen C. Weber, MD – Johns Hopkins Department of Orthopedics/NDA Partners
NDA Partners ### 1187557###Session Leader/Speaker###Senior Medical Advisor###Johns Hopkins Department of Orthopedics/NDA Partners
NDA Partners###Session Leader/Speaker: – Johns Hopkins Department of Orthopedics/NDA Partners
NDA Partners
### @@@ Flora Sandra Siami, MPH – Medical Device Innovation Consortium ### 1375947###Speaker###Senior Vice President, NESTcc###Medical Device Innovation Consortium###Speaker: – Medical Device Innovation Consortium
### @@@ Justin Timbie, PhD – RAND ### 1614530###Speaker###Senior Health Policy Researcher###RAND###Speaker: – RAND
### @@@ Tracy Yu, MSc – BradyKnows Medical, LLC ### 1614534###Speaker###Senior Regulatory Affairs Manager###BradyKnows Medical, LLC###Speaker: – BradyKnows Medical, LLC
###
9:45 AM – 11:00 AM MST
Vaccine Regulatory Pathways – Future Forward
9:45 AM – 11:00 AM MST
Vaccine Regulatory Pathways – Future ForwardLocation/Room:W104 A-BModerator: – Alexion, AstraZeneca Rare Disease
Speaker (Remote): – United States Food and Drug Administration
Speaker (Remote): – European Medicines Agency
Speaker (Remote): – AstraZeneca
Speaker (Remote):
Biopharmaceuticals
Session Room Sponsored By
Joao Duarte, MSc MPharm – Alexion, AstraZeneca Rare Disease ### 720625###Moderator###Director, BPO Regulatory & Quality Affairs###Alexion, AstraZeneca Rare Disease###Moderator: – Alexion, AstraZeneca Rare Disease
### @@@ Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Speaker (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Marco Cavaleri, PhD – European Medicines Agency ### 1061462###Speaker (Remote)###Head of Biological Health Threats and Vaccine Strategy###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Amy Scott-Billman, MS – AstraZeneca ### 1728965###Speaker (Remote)###VP, Global Head Regulatory Affairs, Vaccines & Immune Therapies###AstraZeneca###Speaker (Remote): – AstraZeneca
### @@@ Phyllis Arthur ### 1759439###Speaker (Remote)#########Speaker (Remote):
### 11:00 AM – 4:30 PM MST
Exhibit Hall Open
11:00 AM – 4:30 PM MST
Exhibit Hall OpenLocation/Room:Exhibit Hall
11:00 AM – 4:30 PM MST
Headshot Lounge
11:00 AM – 4:30 PM MST
Headshot LoungeLocation/Room:Exhibit Hall: Booth 939
11:15 AM – 11:40 AM MST
How Can Regulatory Affairs Meet the Needs of Investigational Products, Scale for Future Needs, and Operate Cross-functionally?
11:15 AM – 11:40 AM MST
How Can Regulatory Affairs Meet the Needs of Investigational Products, Scale for Future Needs, and Operate Cross-functionally? Location/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – ArisGlobal LLC
Laura Jones – ArisGlobal LLC ### 1756253###Speaker###Director, Product Regulatory Information Management Systems###ArisGlobal LLC###Speaker: – ArisGlobal LLC
###
11:15 AM – 11:40 AM MST
Transformation in Regulatory Affairs in the Life Sciences
11:15 AM – 11:40 AM MST
Transformation in Regulatory Affairs in the Life SciencesLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Axendia Inc.
Speaker: – Dassault Systèmes
Speaker: – Medidata
Moderator: – Dassault Systèmes
Daniel R. Matlis – Axendia Inc. ### 1756271###Speaker###President###Axendia Inc.###Speaker: – Axendia Inc.
### @@@ Darcy Sheerin – Dassault Systèmes ### 1756272###Speaker###Senior Consultant for Regulatory and Quality Solution###Dassault Systèmes###Speaker: – Dassault Systèmes
### @@@ Jana Hydukovich – Medidata ### 1756274###Speaker###Senior Manager, Global Compliance & Strategy - Medical Devices###Medidata###Speaker: – Medidata
### @@@ Murtuza Vasowalla – Dassault Systèmes ### 1771094###Moderator###Director, Solution Consulting, Life Sciences###Dassault Systèmes###Moderator: – Dassault Systèmes
### 11:15 AM – 11:45 AM MST
Solutions Circle: Global Regulatory Entry in Southeast Asia Emerging Markets: Challenges and Opportunity
11:15 AM – 11:45 AM MST
Solutions Circle: Global Regulatory Entry in Southeast Asia Emerging Markets: Challenges and OpportunityLocation/Room:Exhibit Hall: Booth 104Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
Solutions Circle
Chyue Yie Chew, RAC (EU & US) – ZP Therapeutics, a Division of Zuellig Pharma ### 1523593###Speaker###Regional Regulatory Affairs Manager###ZP Therapeutics, a Division of Zuellig Pharma###Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
### @@@ Fazlin Azura Azlan, Registered Pharmacist – ZP Therapeutics, a Division of Zuellig Pharma ### 1615667###Speaker###Regional Regulatory Affairs Director###ZP Therapeutics, a Division of Zuellig Pharma###Speaker: – ZP Therapeutics, a Division of Zuellig Pharma
### 11:15 AM – 11:45 AM MST
Solutions Circle: The IVD in Companion Diagnostics
11:15 AM – 11:45 AM MST
Solutions Circle: The IVD in Companion DiagnosticsLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Lisa Ryan, BSc, HTL (ASCP BOR) – NAMSA ### 1614385###Speaker###Sr. Clinical Study Manager###NAMSA###Speaker: – NAMSA
### 11:15 AM – 11:45 AM MST
Solutions Circle: What should AI/ML based software manufacturer expect during MDR Audit of their AI systems
11:15 AM – 11:45 AM MST
Solutions Circle: What Should AI/ML Based Software Manufacturer Expect During MDR Audit of Their AI SystemsLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Sara Jafari, PhD – Gmed NA ### 593604###Speaker###Product Reviewer###Gmed NA###Speaker: – Gmed NA
### 11:15 AM – 11:45 AM MST
Solutions Circle: Writing the SSCP for Europe is Child's Work....
11:15 AM – 11:45 AM MST
Solutions Circle: Writing the SSCP for Europe Is Child's Work...Location/Room:Exhibit Hall: Booth 104Solutions Circle
Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Speaker###CSO - CEO###Qserve Group###Speaker: – Qserve Group
###
11:30 AM – 12:30 PM MST
Chapter Meet and Greets
11:30 AM – 12:30 PM MST
Chapter Meet and GreetsLocation/Room:Exhibit Hall: Booth 728
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit Hall
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit HallLocation/Room:Exhibit Hall
11:45 AM – 12:10 PM MST
Quality Management System Regulation (QMSR) - The Road Ahead
11:45 AM – 12:10 PM MST
Quality Management System Regulation (QMSR) - The Road AheadLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – EMMA International Consulting Group
Madison Wheeler, BS, CQA – EMMA International Consulting Group ### 1756288###Speaker###Director of Technical Operations###EMMA International Consulting Group###Speaker: – EMMA International Consulting Group
###
11:45 AM – 12:10 PM MST
RA Leadership: Increasing Confidence in Regulatory Planning
11:45 AM – 12:10 PM MST
RA Leadership: Increasing Confidence in Regulatory PlanningLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
James Gianoutsos, MBA – Rimsys ### 1328412###Speaker###Founder & CEO###Rimsys###Speaker: – Rimsys
###
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Clinical Supply Chain Management of Cell and Gene Therapies: Balancing Imlementation Hurdles, Opportunities, and Threats
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Clinical Supply Chain Management of Cell and Gene Therapies: Balancing Imlementation Hurdles, Opportunities, and ThreatsLocation/Room:Exhibit Hall: Career Central, Booth 728Presenter: – University of Southern California
Lequina Myles, DRSc – University of Southern California ### 1762655###Presenter###Student###University of Southern California###Presenter: – University of Southern California
###
11:45 AM – 12:30 PM MST
Board of Directors Meet and Greets
11:45 AM – 12:30 PM MST
Board of Directors Meet and GreetsLocation/Room:Exhibit Hall: Booth 413
12:00 PM – 12:30 PM MST
Solutions Circle: Advanced tactics for successful Digital Health submissions including AI and Machine Learning
12:00 PM – 12:30 PM MST
Solutions Circle: Advanced Tactics for Successful Digital Health Submissions Including AI and Machine LearningLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Frederike Bruhschwein-Mandic – confinis ag ### 1766413###Speaker###Senior Consultant###confinis ag###Speaker: – confinis ag
### 12:00 PM – 12:30 PM MST
Solutions Circle: Enabling Proactive Quality with Unified Risk Management
12:00 PM – 12:30 PM MST
Solutions Circle: Enabling Proactive Quality with Unified Risk ManagementLocation/Room:Exhibit Hall: Booth 104Speaker: – Veeva Systems
Speaker: – Veeva Systems
Solutions Circle
Danielle Pund, MS, MBA, RAC – Veeva Systems ### 1615692###Speaker###Director, Vault Quality - Strategy###Veeva Systems###Speaker: – Veeva Systems
### @@@ Christine Kattappuram, MS – Veeva Systems ### 1749102###Speaker###Senior Director, MedTech Quality Strategy###Veeva Systems###Speaker: – Veeva Systems
### 12:00 PM – 12:30 PM MST
Solutions Circle: Regulatory strategy for market entry to India for a Medical Device company
12:00 PM – 12:30 PM MST
Solutions Circle: Regulatory Strategy for Market Entry to India for a Medical Device CompanyLocation/Room:Exhibit Hall: Booth 104Speaker: – Regulatory Wisdom
Solutions Circle
Rashmi Kulshrestha, PhD – Regulatory Wisdom ### 1614384###Speaker###Founder and CEO###Regulatory Wisdom###Speaker: – Regulatory Wisdom
### 12:00 PM – 12:30 PM MST
Solutions Circle: The Elephant in the Room: Developing a Sustainable Approach to IVDR Post-Market Compliance
12:00 PM – 12:30 PM MST
Solutions Circle: The Elephant in the Room: Developing a Sustainable Approach to IVDR Post-market ComplianceLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Sean Smith, MA – Huma.AI ### 1777032###Speaker###Regulatory Compliance Solutions Lead###Huma.AI###Speaker: – Huma.AI
### 12:20 PM – 12:45 PM MST
Instant CER/PSUR Data Table Creation for EU-MDR/IVDR Submissions – A New Reality
12:20 PM – 12:45 PM MST
Instant CER/PSUR Data Table Creation for EU-MDR/IVDR Submissions – A New RealityLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Ross Meisner – Basil Systems ### 1756322###Speaker###Chief Commercial Officer###Basil Systems###Speaker: – Basil Systems
###
12:20 PM – 12:45 PM MST
Unveiling Impactful Methods to Strengthen Device Claims
12:20 PM – 12:45 PM MST
Unveiling Impactful Methods to Strengthen Device ClaimsLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337
Smridula S. Hariharan, MPharm – Celegence ### 1757738###Speaker###Deputy Manager###Celegence###Speaker: – Celegence
###
12:30 PM – 1:00 PM MST
Career Central Presentation: The Value of RAC Certifications
12:30 PM – 1:00 PM MST
Career Central Presentation: The Value of RAC CertificationsLocation/Room:Exhibit Hall: Booth 728
Jennifer Naughton ### 1763591###Presenter#########Presenter:
###
12:45 PM – 1:15 PM MST
Artificial Intelligence Meet Up
12:45 PM – 1:15 PM MST
Artificial Intelligence Meet UpLocation/Room:Exhibit Hall: Booth 413Guest Speaker: – AFDO/RAPS Healthcare Products Collaborative
Timothy Hsu – AFDO/RAPS Healthcare Products Collaborative ### 1757583###Guest Speaker###Director of Health Technology Initiatives###AFDO/RAPS Healthcare Products Collaborative###Guest Speaker: – AFDO/RAPS Healthcare Products Collaborative
### 12:45 PM – 1:15 PM MST
Meet the Authors: Postapproval Changes for Drugs: A Practical Guide by Linda McBride and Pallavi Trivedi
12:45 PM – 1:15 PM MST
Meet the Authors: Postapproval Changes for Drugs: A Practical Guide by Linda McBride and Pallavi TrivediLocation/Room:RAPS Store (Registration Foyer)
12:45 PM – 1:15 PM MST
Software as Medical Device (Diagnostic, Preventive, Mental health related) Under EU MDR
12:45 PM – 1:15 PM MST
Software as Medical Device (Diagnostic, Preventive, Mental health related) Under EU MDRLocation/Room:Exhibit Hall: Booth 104Speaker: – Medical Audit, NAM Knowledge
Solutions Circle
Balazs Bozsik, MSc, MBA – Medical Audit, NAM Knowledge ### 1614547###Speaker###Technical Director###Medical Audit, NAM Knowledge###Speaker: – Medical Audit, NAM Knowledge
###
12:45 PM – 1:15 PM MST
Solutions Circle: Best practices for avoiding clinical holds for your cell and gene therapy product INDs
12:45 PM – 1:15 PM MST
Solutions Circle: Best Practices for Avoiding Clinical Holds for Your Cell and Gene Therapy Product IndsLocation/Room:Exhibit Hall: Booth 104Speaker: – Graybug Vision, Inc
Solutions Circle
Fang Li, PHD, RAC – Graybug Vision, Inc ### 1615695###Speaker###VP, RA###Graybug Vision, Inc###Speaker: – Graybug Vision, Inc
### 12:45 PM – 1:15 PM MST
Solutions Circle: New challenges of nanomaterials under the MDR – using a risk-based approach to demonstrate compliance
12:45 PM – 1:15 PM MST
Solutions Circle: New Challenges of Nanomaterials Under the MDR – Using a Risk-based Approach to Demonstrate ComplianceLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Matt Royle, PhD – NAMSA ### 907121###Speaker###Principal Regulatory Consultant###NAMSA###Speaker: – NAMSA
### 12:45 PM – 1:15 PM MST
Solutions Circle: RAPS Chapters Unite!
12:45 PM – 1:15 PM MST
Solutions Circle: RAPS Chapters Unite!Location/Room:Exhibit Hall: Booth 104Speaker: – Day One Biopharmaceuticals
Speaker: – Integrated Project Management Company, Inc.
Solutions Circle
Lindsey Summers, MBA – Day One Biopharmaceuticals ### 802197###Speaker###Sr Talent Acquisition Partner###Day One Biopharmaceuticals###Speaker: – Day One Biopharmaceuticals
### @@@ Susan E. Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc. ### 1000086###Speaker###Principal Consultant###Integrated Project Management Company, Inc.###Speaker: – Integrated Project Management Company, Inc.
### 12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring"
12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring" Location/Room:Exhibit Hall: Booth 728
12:55 PM – 1:20 PM MST
Avoiding Medical Device Clinical Evaluation Pitfalls
12:55 PM – 1:20 PM MST
Avoiding Medical Device Clinical Evaluation PitfallsLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337
Angela Siebeneck, MSN RN – Certara ### 1756320###Speaker###Director, Regulatory Strategy and Policy###Certara###Speaker: – Certara
###
12:55 PM – 1:20 PM MST
Moving to Digital Labelling: Journey to Achieving Desired Outcomes
12:55 PM – 1:20 PM MST
Moving to Digital Labelling: Journey to Achieving Desired OutcomesLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Indegene
Speaker:
Vladimir Penkrat, MBA – Indegene ### 1756301###Speaker###Associate Vice President, Head of Regulatory Affairs###Indegene###Speaker: – Indegene
### @@@ Sonica Batra ### 1773337###Speaker#########Speaker:
###
1:15 PM – 1:45 PM MST
Career Central Presentation: Value of the RAPS Regulatory Competency Framework
1:15 PM – 1:45 PM MST
Career Central Presentation: Value of the RAPS Regulatory Competency FrameworkLocation/Room:Exhibit Hall: Booth 728Presenter: – QRE MedTech LLC
Thomas Hutchinson, MS RAC FRAPS – QRE MedTech LLC ### 1764013###Presenter###Principal Consultant###QRE MedTech LLC###Presenter: – QRE MedTech LLC
###
1:30 PM – 1:55 PM MST
Best Approaches to Managing a Product Recall Under the FDA’s Post-COVID Scrutiny
1:30 PM – 1:55 PM MST
Best Approaches to Managing a Product Recall Under the FDA’s Post-COVID ScrutinyLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Matt Walker – Sedgwick ### 1762923###Speaker###Business Development###Sedgwick###Speaker: – Sedgwick
###
1:30 PM – 1:55 PM MST
Regulatory Labeling Changes and Challenges
1:30 PM – 1:55 PM MST
Regulatory Labeling Changes and ChallengesLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – Network Partners
Speaker: – Network Partners
Heather Valley, MS, RAC – Network Partners ### 1756304###Speaker###Senior Director, Regulatory Affairs Medical Device###Network Partners###Speaker: – Network Partners
### @@@ Ashley Dynan, MPH, CQA – Network Partners ### 1756305###Speaker###Principal Regulatory Consultant###Network Partners###Speaker: – Network Partners
###
1:30 PM – 2:00 PM MST
Solutions Circle: A Comparison of Clinical Trial Application and Inspections in Semi-regulated market and FDA
1:30 PM – 2:00 PM MST
Solutions Circle: A Comparative Analysis of Clinical Trial Regulation in a Semi-Regulated Market and FDALocation/Room:Exhibit Hall: Booth 104Speaker: – Botswana Medicines Regulatory Authority
Solutions Circle
Tshetsana Senau – Botswana Medicines Regulatory Authority ### 1615694###Speaker###Regulatory Officer###Botswana Medicines Regulatory Authority###Speaker: – Botswana Medicines Regulatory Authority
###
1:30 PM – 2:00 PM MST
Solutions Circle: How to Solve the US, EU, and Global Unique Device Identification (UDI) Puzzle
1:30 PM – 2:00 PM MST
Solutions Circle: How to Solve the US, EU, and Global Unique Device Identification (UDI) Puzzle Location/Room:Exhibit Hall: Booth 104Solutions Circle
Gary Saner – Reed Tech ### 1321700###Speaker###Sr. Manager Information Solutions###Reed Tech###Speaker: – Reed Tech
### 1:30 PM – 2:00 PM MST
Solutions Circle: Regulatory Agreements for Drug Development Collaborations
1:30 PM – 2:00 PM MST
Solutions Circle: Regulatory Agreements for Drug Development CollaborationsLocation/Room:Exhibit Hall: Booth 104Speaker: – Ascendis Pharma
Speaker: – Department of Regulatory & Quality Sciences USC School of Pharmacy
Solutions Circle
Mary E. Wilhelm, DRSc, RAC US, RAC EU – Ascendis Pharma ### 1615682###Speaker###Senior Director, Regulatory Affairs###Ascendis Pharma###Speaker: – Ascendis Pharma
### @@@ Nancy Pire-Smerkanich, DRSc – Department of Regulatory & Quality Sciences USC School of Pharmacy ### 1615683###Speaker###Assistant Professor###Department of Regulatory & Quality Sciences USC School of Pharmacy###Speaker: – Department of Regulatory & Quality Sciences USC School of Pharmacy
### 1:30 PM – 2:00 PM MST
Solutions Circle: Trailblazing Regulatory Paths for Gene Therapy
1:30 PM – 2:00 PM MST
Solutions Circle: Trailblazing Regulatory Paths for Gene TherapyLocation/Room:Exhibit Hall: Booth 104Speaker: – Integrated Project Management, Inc.
Solutions Circle
Stacy Townsend, PhD, PMP – Integrated Project Management, Inc. ### 1615693###Speaker###Project Management Consultant###Integrated Project Management, Inc.###Speaker: – Integrated Project Management, Inc.
### 2:00 PM – 3:00 PM MST
AsiaPac- Accelerating Drug Development and Approvals in India and Australia
2:00 PM – 3:00 PM MST
AsiaPac- Accelerating Drug Development and Approvals in India and AustraliaLocation/Room:W106 CSession Leader/Speaker: – AbbVie
Speaker: – University of Sydney
Biopharmaceuticals
Business Acumen Domain, Level 1
Session Room Sponsored By
Ana Sengupta, MS, MBA, RAC – AbbVie ### 1615710###Session Leader/Speaker###Regulatory Affairs CMC, AbbVie Inc.###AbbVie###Session Leader/Speaker: – AbbVie
### @@@ Orin Chisholm, GCULT, PhD, SFHEA, FRAPS – University of Sydney ### 1615707###Speaker###Senior lecturer###University of Sydney###Speaker: – University of Sydney
###
2:00 PM – 3:00 PM MST
Broadening Consumer / Patient Access to Medicines Through Technology-Enabled Interactions. Lifecycle Management & Rx-to-OTC Strategies
2:00 PM – 3:00 PM MST
Broadening Consumer / Patient Access to Medicines Through Technology-Enabled Interactions. Lifecycle Management & Rx-to-OTC StrategiesLocation/Room:W103 A-BSession Leader/Speaker: – Haleon
Speaker: – Beacon Associates, LLC
Speaker: – Klick Consulting
Speaker: – PEGUS Research
Biopharmaceuticals
Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Session Leader/Speaker###Senior Director, Regulatory Affairs###Haleon###Session Leader/Speaker: – Haleon
### @@@ Paul A. Wardle, MA, MMath – Beacon Associates, LLC ### 1615713###Speaker###Founder and Principal###Beacon Associates, LLC###Speaker: – Beacon Associates, LLC
### @@@ Alfred Whitehead, MAs, MS, CISSP – Klick Consulting ### 1615714###Speaker###EVP Applied Sciences###Klick Consulting###Speaker: – Klick Consulting
### @@@ Clark Richardson, MPH – PEGUS Research ### 1615717###Speaker###President & CEO at PEGUS Research###PEGUS Research###Speaker: – PEGUS Research
###
2:00 PM – 3:00 PM MST
Clinical Evaluation
2:00 PM – 3:00 PM MST
Safety and Performance Specifications - Challenges and solutionsLocation/Room:W102 A-CSession Leader/Speaker: – Medidee Services SA
Speaker: – RQM+
Speaker: – Qserve Group
Medical Devices
Session Room Sponsored By
Richard Curno, PhD – Medidee Services SA ### 1614544###Session Leader/Speaker###Chief Scientific Officer###Medidee Services SA###Session Leader/Speaker: – Medidee Services SA
### @@@ Jaishankar Kutty, PhD – RQM+ ### 1523601###Speaker###VP, Intelligence and Innovation###RQM+###Speaker: – RQM+
### @@@ Mindy McCann – Qserve Group ### 720640###Speaker###VP Regulatory Compliance###Qserve Group###Speaker: – Qserve Group
###
2:00 PM – 3:00 PM MST
Conversations That Matter (Drugs, Biologics and Combination Products)
2:00 PM – 3:00 PM MST
Conversations That Matter (Drugs, Biologics and Combination Products)Location/Room:W105 A-CModerator:
Moderator:
Speaker (Remote): – United States Food and Drug Administration
Speaker: – European Medicines Agency
Speaker:
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker (Remote): – United States Food and Drug Administration
Speaker: – Botswana Medicines Regulatory Authority
Speaker (Remote): – US Food and Drug Administration
Conversations That Matter
Susan Stewart ### 1698805###Moderator#########Moderator:
### @@@ Jethro Ekuta ### 1698806###Moderator#########Moderator:
### @@@ La'Nissa Brown-Baker, PhD, DABT – United States Food and Drug Administration ### 1428548###Speaker (Remote)###Associate Director for Scientific Staffing###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Sabina Hoekstra ### 1083897###Speaker#########Speaker:
### @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###Speaker: – AGES (Austrian Agency for Health & Food Safety)
### @@@ Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Speaker (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Tshetsana Senau – Botswana Medicines Regulatory Authority ### 1615694###Speaker###Regulatory Officer###Botswana Medicines Regulatory Authority###Speaker: – Botswana Medicines Regulatory Authority
### @@@ Kim Smith – US Food and Drug Administration ### 1778366###Speaker (Remote)###Chief Medical Officer###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### 2:00 PM – 3:00 PM MST
Essential Debate - Lessons Learned from the Implementation of the EU Regulations
2:00 PM – 3:00 PM MST
Essential Debate - Lessons Learned from the Implementation of the EU Regulations Location/Room:W106 A-BModerator: – Akra Team GmbH
Speaker: – Qserve Group
Speaker: – TUV Sud GmbH
Speaker: – RQM+
Speaker: – DNV Product Assurance AS
In Vitro Diagnostics
Session Room Sponsored By
Bassil Akra, phD – Akra Team GmbH ### 535482###Moderator###Chief Executive Officer###Akra Team GmbH###Moderator: – Akra Team GmbH
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Speaker###CSO - CEO###Qserve Group###Speaker: – Qserve Group
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Speaker###IVD Technical Director###TUV Sud GmbH###Speaker: – TUV Sud GmbH
### @@@ Carlos Galamba – RQM+ ### 1523600###Speaker###Vice President IVD, Intelligence & Innovation###RQM+###Speaker: – RQM+
### @@@ Yuan Li, PhD – DNV Product Assurance AS ### 1729626###Speaker###PhD###DNV Product Assurance AS###Speaker: – DNV Product Assurance AS
###
2:00 PM – 3:00 PM MST
Experience with the Clinical Trials Regulation and Clinical Trial Information System to date
2:00 PM – 3:00 PM MST
Experience with the Clinical Trials Regulation and Clinical Trial Information System to DateLocation/Room:W104 A-BSession Leader/Speaker: – Agency IQ
Speaker: – European Medicines Agency
Speaker (Remote): – Seagen
Speaker (Remote): – Zealand Pharma
Speaker (Remote): – Shionogi
Biopharmaceuticals
Kirsten Messmer, PhD, RAC – Agency IQ ### 595312###Session Leader/Speaker###Senior Research Analyst###Agency IQ###Session Leader/Speaker: – Agency IQ
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Shaila Choi, MSc, MTOPRA, CSci – Seagen ### 1730178###Speaker (Remote)###Regulatory Affairs Director###Seagen###Speaker (Remote): – Seagen
### @@@ Selma Stockner, MA – Zealand Pharma ### 1730176###Speaker (Remote)###Clinical Reporting and Documentation Specialist###Zealand Pharma###Speaker (Remote): – Zealand Pharma
### @@@ Bertrand Fournier – Shionogi ### 1730177###Speaker (Remote)###Director, Regulatory Policy & Intelligence###Shionogi###Speaker (Remote): – Shionogi
###
2:00 PM – 3:00 PM MST
Marketing, Advertising and Claims for Devices Under the Amended FDA Intended Use Regulation and Under MDR / IVDR
2:00 PM – 3:00 PM MST
Marketing, Advertising and Claims for Devices Under the Amended FDA Intended Use Regulation and Under MDR / IVDRLocation/Room:W101 A-BSession Leader/Speaker: – CM Cooper & Associates
Speaker: – Siemens Healthineers
Speaker: – Axon Lawyers
Medical Devices
Session Room Sponsored By
Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates ### 1630469###Session Leader/Speaker###Principal###CM Cooper & Associates###Session Leader/Speaker: – CM Cooper & Associates
### @@@ Monika Bhatt, LL.M – Siemens Healthineers ### 1614394###Speaker###Chief Counsel FDA and Healthcare Regulatory Compliance###Siemens Healthineers###Speaker: – Siemens Healthineers
### @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Speaker###Partner###Axon Lawyers###Speaker: – Axon Lawyers
###
2:00 PM – 3:00 PM MST
PDUFA VII Commitment Letter – What’s in, What’s out and What you should know about
2:00 PM – 3:00 PM MST
PDUFA VII – What’s In, What’s out and What You Should Know AboutLocation/Room:W101 CSession Leader/Speaker: – Asher Biotherapeutics
Speaker: – Gilead Sciences Inc. - ENTERPRISE
Speaker: – Accumulus Synergy
Speaker (Remote): – U.S. FDA Center for Drug Evaluation and Research
Biopharmaceuticals
Aditi Khurana, MBA, PMP, RAC – Asher Biotherapeutics ### 1340362###Session Leader/Speaker###Director, Project Management###Asher Biotherapeutics###Session Leader/Speaker: – Asher Biotherapeutics
### @@@ Heidi Christl Marchand, PharmD – Gilead Sciences Inc. - ENTERPRISE ### 1042127###Speaker###Executive Director###Gilead Sciences Inc. - ENTERPRISE###Speaker: – Gilead Sciences Inc. - ENTERPRISE
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Speaker###Chief Regulatory Innovation Officer###Accumulus Synergy###Speaker: – Accumulus Synergy
### @@@ Mary Ann Slack – U.S. FDA Center for Drug Evaluation and Research ### 1773298###Speaker (Remote)###Director, Office of Strategic Programs###U.S. FDA Center for Drug Evaluation and Research###Speaker (Remote): – U.S. FDA Center for Drug Evaluation and Research
###
2:00 PM – 4:00 PM MST
Resume Reviews and Career Coaching
2:00 PM – 4:00 PM MST
Resume Reviews and Career CoachingLocation/Room:Exhibit Hall: Booth 728
3:00 PM – 3:30 PM MST
Coffee & Refreshment Break
3:00 PM – 3:30 PM MST
Coffee & Refreshment BreakLocation/Room:Session Rooms: W101-106 Foyers
3:30 PM – 4:30 PM MST
Advanced Therapies: Emerging Challenges throughout the Product Lifecycle
3:30 PM – 4:30 PM MST
Advanced Therapies: Emerging Challenges Throughout the Product LifecycleLocation/Room:W103 A-BSession Leader/Speaker: – Agency IQ
Speaker: – Enzyvant Therapeutics, Inc.
Speaker: – Taysha Gene Therapies
Biopharmaceuticals
Kirsten Messmer, PhD, RAC – Agency IQ ### 595312###Session Leader/Speaker###Senior Research Analyst###Agency IQ###Session Leader/Speaker: – Agency IQ
### @@@ Kevin Healy, PhD, RAC – Enzyvant Therapeutics, Inc. ### 535498###Speaker###Senior Vice President###Enzyvant Therapeutics, Inc.###Speaker: – Enzyvant Therapeutics, Inc.
### @@@ Mary S. Newman, BS, MS – Taysha Gene Therapies ### 861203###Speaker######Taysha Gene Therapies###Speaker: – Taysha Gene Therapies
###
3:30 PM – 4:30 PM MST
Health Authority Forum - CDRH
3:30 PM – 4:30 PM MST
Health Authority Forum - CDRHLocation/Room:W105 A-CSpeaker (Remote): – United States Food and Drug Administration
Speaker (Remote):
Speaker: – U.S. Food and Drug Administration
Speaker (Remote): – US Food and Drug Administration
Speaker (Remote): – U.S. Food and Drug Administration
Speaker (Remote): – US Food and Drug Administration
Moderator: – Thermo Fisher Scientific
Health Authority Forum
Jeffrey Shuren, MD, JD – United States Food and Drug Administration ### 1083196###Speaker (Remote)###Director of the Center for Devices and Radiological Health###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Barbara Zimmerman ### 1761187###Speaker (Remote)#########Speaker (Remote):
### @@@ Doug Kelly, MD – U.S. Food and Drug Administration ### 1416709###Speaker###Deputy Center Director for Science, Chief Scientist###U.S. Food and Drug Administration###Speaker: – U.S. Food and Drug Administration
### @@@ Daniel Caños, PhD, MPH – US Food and Drug Administration ### 1083194###Speaker (Remote)###Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### @@@ Michelle Tarver, MD, PhD – U.S. Food and Drug Administration ### 1052823###Speaker (Remote)###Deputy Director, Office of Strategic Partnerships and Technology Innovation###U.S. Food and Drug Administration###Speaker (Remote): – U.S. Food and Drug Administration
### @@@ Eli Tomar, JD, MPH – US Food and Drug Administration ### 1083197###Speaker (Remote)###Associate Director for Guidance, Legislation and Special Projects, Office of Policy, CDRH###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### @@@ Megha Deviprasad Iyer, MS, RAC – Thermo Fisher Scientific ### 1083158###Moderator###Global Director, Regulatory Affairs###Thermo Fisher Scientific###Moderator: – Thermo Fisher Scientific
###
3:30 PM – 4:30 PM MST
Postmarketing Clinical Follow-up (PMCF) & Risk Management
3:30 PM – 4:30 PM MST
A Lifecycle Case Study - Smooth Crossover Between Clinical Evaluation, PMCF and Risk ManagementLocation/Room:W101 A-BSession Leader/Speaker: – Qserve
Speaker: – Dr. Ebeling & Assoc. GmbH
Speaker: – RQM+
Medical Devices
Session Room Sponsored By
Keith Morel, PhD – Qserve ### 535522###Session Leader/Speaker###VP Regulatory Compliance###Qserve###Session Leader/Speaker: – Qserve
### @@@ Jasmin Lindner, PhD – Dr. Ebeling & Assoc. GmbH ### 1000106###Speaker###Lead Medical Device###Dr. Ebeling & Assoc. GmbH###Speaker: – Dr. Ebeling & Assoc. GmbH
### @@@ Celeste Ann Maksim, PhD – RQM+ ### 1092278###Speaker###Chief of Staff, Clinical & Post-Market Practice###RQM+###Speaker: – RQM+
###
3:30 PM – 4:30 PM MST
Real-World Evidence Case Studies for Marketing Applications and Post-marketing Safety Evaluations
3:30 PM – 4:30 PM MST
Real-World Evidence Case Studies for Marketing Applications and Post-marketing Safety EvaluationsLocation/Room:W104 A-BSession Leader/Speaker: – Bristol-Myers Squibb
Speaker: – Pardes Biosciences
Speaker (Remote): – United States Food and Drug Administration, Center for Drug Evaluation and Research
Biopharmaceuticals
Session Room Sponsored By
Kerrie Nagrod, MSJ – Bristol-Myers Squibb ### 1615705###Session Leader/Speaker###Director, Global Regulatory Lead###Bristol-Myers Squibb###Session Leader/Speaker: – Bristol-Myers Squibb
### @@@ Michelle P. Pernice, PharmD – Pardes Biosciences ### 1615703###Speaker###VP Regulatory Affairs###Pardes Biosciences###Speaker: – Pardes Biosciences
### @@@ John Concato, MD, MS, MPH – United States Food and Drug Administration, Center for Drug Evaluation and Research ### 1422982###Speaker (Remote)###Associate Director for Real-World Evidence Analytices###United States Food and Drug Administration, Center for Drug Evaluation and Research###Speaker (Remote): – United States Food and Drug Administration, Center for Drug Evaluation and Research
###
3:30 PM – 4:30 PM MST
Recent Developments in LDTs
3:30 PM – 4:30 PM MST
Rollout EU IVDR (2017/746) 2022: In-House Manufacturing of IVD's Under the IVDR Ruling: What Challenges Lie Ahead?Location/Room:W102 A-CSession Leader/Speaker: – NAMSA
Speaker: – TUV SUD
Speaker: – University Hospital Leuven, Belgium
In Vitro Diagnostics
Session Room Sponsored By
Alex Laan, Dipl.-Ing. – NAMSA ### 1141533###Session Leader/Speaker###Principal Regulatory Consultant, IVD###NAMSA###Session Leader/Speaker: – NAMSA
### @@@ Julien S. Senac, PhD – TUV SUD ### 1022552###Speaker###Director - IVD Global Focus Team###TUV SUD###Speaker: – TUV SUD
### @@@ Elisabeth PhD Dequeker, PhD – University Hospital Leuven, Belgium ### 1254350###Speaker###Full Professor in Quality Management###University Hospital Leuven, Belgium###Speaker: – University Hospital Leuven, Belgium
###
3:30 PM – 4:30 PM MST
Traveling to De Novo Land: Planning for a Successful Journey
3:30 PM – 4:30 PM MST
Traveling to De Novo Land: Planning for a Successful JourneyLocation/Room:W106 A-BSession Leader/Speaker: – DuVal & Associates, P.A.
Speaker: – DuVal & Associates, P.A.
Speaker (Remote): – Food and Drug Administration
Medical Devices
Session Room Sponsored By
Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Session Leader/Speaker###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Session Leader/Speaker: – DuVal & Associates, P.A.
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Speaker###Regulatory Consultant###DuVal & Associates, P.A.###Speaker: – DuVal & Associates, P.A.
### @@@ Peter Yang, PhD – Food and Drug Administration ### 1083214###Speaker (Remote)######Food and Drug Administration###Speaker (Remote): – Food and Drug Administration
###
3:30 PM – 4:30 PM MST
You Want to Make a Difference. FDA Wants to Hire You!
3:30 PM – 4:30 PM MST
You Want to Make a Difference. FDA Wants to Hire You!Location/Room:W101 CSpeaker (Remote): – United States Food and Drug Administration
Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
Speaker: – US Food & Drug Administration / CBER
Speaker (Remote): – FDA/CDRH/OPEQ
Speaker (Remote): – FDA/OC/OCS/OCET
Skill Building
La'Nissa Brown-Baker, PhD, DABT – United States Food and Drug Administration ### 1428548###Speaker (Remote)###Associate Director for Scientific Staffing###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Sonday L. Kelly, MS, RAC, PMP – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Moderator###Staff Director###Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration###Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Katherine Kim, MPH, RAC, CQA – US Food & Drug Administration / CBER ### 1728974###Speaker###Acting Senior Advisor for Medical Device###US Food & Drug Administration / CBER###Speaker: – US Food & Drug Administration / CBER
### @@@ Stephanie Shedd, RAC, CQA – FDA/CDRH/OPEQ ### 1728975###Speaker (Remote)###Biomedical Engineer###FDA/CDRH/OPEQ###Speaker (Remote): – FDA/CDRH/OPEQ
### @@@ Thomas Maruna, MSc, MA, PMP, CPH, MLS(ASCP) – FDA/OC/OCS/OCET ### 1728976###Speaker (Remote)###Senior Scientific Program Manager###FDA/OC/OCS/OCET###Speaker (Remote): – FDA/OC/OCS/OCET
###
4:35 PM – 5:30 PM MST
A Bit’s Life: Life Cycle of Big Data, Real-world Evidence, and Safety Analytics in the Context of Health Authority Decision-making
4:35 PM – 5:30 PM MST
A Bit’s Life: Life Cycle of Big Data, Real-world Evidence, and Safety Analytics in the Context of Health Authority Decision-makingLocation/Room:W104 A-BSpeaker (Remote): – Food and Drug Administration
Speaker (Remote): – European Medicines Agency
Speaker: – European Medicines Agency
Biopharmaceuticals
Session Room Sponsored By
Viashali Popat, MD, MPH – Food and Drug Administration ### 1728958###Speaker (Remote)###Associate Director of Biomedical Informatics###Food and Drug Administration###Speaker (Remote): – Food and Drug Administration
### @@@ Andrej Segec, MPharm MSc – European Medicines Agency ### 1748282###Speaker (Remote)###Scientific administrator, DARWIN EU® Project manager###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
###
4:35 PM – 5:30 PM MST
Combined Session for Topic: Generic Drug Development and Approval
4:35 PM – 5:30 PM MST
EU Generics – When Does a Simple Procedure Become Complex?Location/Room:W106 CSession Leader/Speaker: – Parexel
Biopharmaceuticals
Michael Craig, BSc Pharm, M.P.S.I – Parexel ### 535462###Session Leader/Speaker###Vice President (Technical)###Parexel###Session Leader/Speaker: – Parexel
###
4:35 PM – 5:30 PM MST
Digital Health/Software as a Medical Device/Mobile Apps and e-Labeling/Wearables
4:35 PM – 5:30 PM MST
Digital Health/Software as a Medical Device/mobile Apps and E-labeling/WearablesLocation/Room:W106 A-BSession Leader/Speaker: – Hogan Lovells LLP
Speaker: – Medical Audit, NAM Knowledge
Speaker: – Cisema / RAPS Member
Speaker: – PMDA
Medical Devices
Session Room Sponsored By
W. Alex Smith, MBA, RAC – Hogan Lovells LLP ### 1614526###Session Leader/Speaker###Regulatory Director###Hogan Lovells LLP###Session Leader/Speaker: – Hogan Lovells LLP
### @@@ Balazs Bozsik, MSc, MBA – Medical Audit, NAM Knowledge ### 1614547###Speaker###Technical Director###Medical Audit, NAM Knowledge###Speaker: – Medical Audit, NAM Knowledge
### @@@ Hamish King, RAC, CFA – Cisema / RAPS Member ### 1321685###Speaker###COO###Cisema / RAPS Member###Speaker: – Cisema / RAPS Member
### @@@ Kuniki Imagawa, MSc – PMDA ### 1614535###Speaker###Principal Officer, Office of Standards and Compliance for Medical Devices###PMDA###Speaker: – PMDA
###
4:35 PM – 5:30 PM MST
Health Authority Forum - Canada
4:35 PM – 5:30 PM MST
Health Authority Forum - CanadaLocation/Room:W105 A-CSpeaker (Remote): – Health Canada
Moderator: – IAA Consulting LLC
Speaker: – Health Canada
Health Authority Forum
Bruce Randall, B. Sc – Health Canada ### 1402493###Speaker (Remote)###Senior Executive Director###Health Canada###Speaker (Remote): – Health Canada
### @@@ Linda McBride, R.Ph., RAC – IAA Consulting LLC ### 720634###Moderator###Regulatory and Compliance Consultant###IAA Consulting LLC###Moderator: – IAA Consulting LLC
### @@@ David Boudreau, ing – Health Canada ### 570151###Speaker###Director General###Health Canada###Speaker: – Health Canada
###
4:35 PM – 5:30 PM MST
Machine Teaching: A case study in training machine learning software to read FDA approvals
4:35 PM – 5:30 PM MST
Machine Teaching: A Case Study in Training Machine Learning Software to Read FDA ApprovalsLocation/Room:W103 A-BSession Leader/Speaker: – Seagen Inc.
Broad Interest
Chris Whalley – Seagen Inc. ### 1000102###Session Leader/Speaker###Associate Director, Regulatory Policy & Intelligence###Seagen Inc.###Session Leader/Speaker: – Seagen Inc.
###
4:35 PM – 5:30 PM MST
Notified Body's Experience with Appropriate Surveillance under Article 120(3)
4:35 PM – 5:30 PM MST
Notified Body's Experience with Appropriate Surveillance Under Article 120(3)Location/Room:W101 A-BSession Leader/Speaker: – BSI
Speaker: – Strategic Business Development at TÜV SÜD
Speaker: – DNV
Medical Devices
Session Room Sponsored By
Keti S. Agostino – BSI ### 1614397###Session Leader/Speaker###Regulatory Lead###BSI###Session Leader/Speaker: – BSI
### @@@ Martin Witte – Strategic Business Development at TÜV SÜD ### 1187576###Speaker###Senior Director###Strategic Business Development at TÜV SÜD ###Speaker: – Strategic Business Development at TÜV SÜD
### @@@ Alexey Shiryaev, MD, PhD – DNV ### 1645653###Speaker###Head of Clinical and Regulatory Affairs###DNV###Speaker: – DNV
###
4:35 PM – 5:30 PM MST
Pediatric Medical Devices
4:35 PM – 5:30 PM MST
Pediatric Medical Devices: Overcoming the BarriersLocation/Room:W102 A-CSession Leader/Speaker: – U.S. Food and Drug Administration
Speaker: – PMDA
Speaker: – PMDA
Speaker: – Abbott
Medical Devices
Session Room Sponsored By
Nicole Ibrahim, PhD – U.S. Food and Drug Administration ### 1614538###Session Leader/Speaker###Division Director, Division of Health Technology 2 B, Office of Product Evaluation and Quality, CDRH###U.S. Food and Drug Administration###Session Leader/Speaker: – U.S. Food and Drug Administration
### @@@ Mami Ho, MD.PhD. – PMDA ### 1614537###Speaker###Senior Scientist for Clinical Medicine, Office of Medical Devices I###PMDA###Speaker: – PMDA
### @@@ Marika Doi, PhD – PMDA ### 1614539###Speaker###Reviewer, Office of Medical Devices II###PMDA###Speaker: – PMDA
### @@@ Amra Racic – Abbott ### 1614546###Speaker###Director RIS###Abbott###Speaker: – Abbott
###
5:45 PM – 7:15 PM MST
Honoring Excellence: RAPS 2022 Awards Celebration invitation Only
5:45 PM – 7:15 PM MST
Honoring Excellence: RAPS 2022 Awards Celebration invitation OnlyLocation/Room:Symphony Hall Foyer
6:00 PM – 9:00 PM MST
Dine-Arounds - Sign Up & Meet Up
6:00 PM – 9:00 PM MST
Dine-Arounds - Sign Up & Meet Up Location/Room:Registration
6:00 PM – 9:00 PM MST
Offsite Event: Arizona Diamondbacks vs. LA Dodgers*
*Separate Ticketed Event
6:00 PM – 9:00 PM MST
Offsite Event: AZ Dbacks vs. LA Dodgers - IMPORTANT: Please review Chase Field Policies Before You Go
separate Ticketed EventLocation/Room:Offsite: Chase Field
- Tuesday, September 13, 2022
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check In
6:00 AM – 6:30 AM MST
Wellness at RAPS Convergence: Check InLocation/Room:Hyatt Regency Phoenix, Offsite: Hyatt Regency Phoenix Ballroom
6:00 AM – 6:30 PM MST
First Aid Services
6:00 AM – 6:30 PM MST
First Aid Services
Location/Room:Exhibit Hall 1: Back of Hall
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Guided Meditation
6:30 AM – 7:30 AM MST
Wellness at RAPS Convergence: Yoga for Good Posture & Guided MeditationLocation/Room:Offsite: Hyatt Regency Phoenix Ballroom
6:30 AM – 3:00 PM MST
Registration Open
6:30 AM – 3:00 PM MST
Registration Open
Location/Room:West Hall 1-3 Lobby, Lower Level
7:00 AM – 3:30 PM MST
Mobile App Support Desk
7:00 AM – 3:30 PM MST
Mobile App Support DeskLocation/Room:West Hall 1-3 Lobby, Lower Level
7:30 AM – 8:45 AM MST
Community Gathering & Continental Breakfast
7:30 AM – 8:45 AM MST
Community Gathering & Continental BreakfastLocation/Room:W301 A-D Lobbies
7:30 AM – 5:00 PM MST
RAPS Store
7:30 AM – 5:00 PM MST
RAPS Store
Location/Room:West Hall 1-3 Lobby, Lower Level
7:30 AM – 6:00 PM MST
Press Room
7:30 AM – 6:00 PM MST
Press Room
Location/Room:W203
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
8:00 AM – 4:00 PM MST
Speaker Ready Room Open
Location/Room:W202
8:15 AM – 9:30 AM MST
Plenary Session: Advancing Science Through Collaboration: Celebrating Friends of Cancer Research, Recipient of the 2022 Patient-Centered Health Award
8:15 AM – 9:30 AM MST
Plenary Session: Advancing Science Through Collaboration: Celebrating Friends of Cancer Research, Recipient of the 2022 Patient-Centered Health AwardLocation/Room:W301 A-DSpeaker: – Friends of Cancer Research
Moderator: – Velvet Chainsaw Consulting
Jeff Allen – Friends of Cancer Research ### 1759672###Speaker###President and CEO###Friends of Cancer Research###Speaker: – Friends of Cancer Research
### @@@ Sarah Michel, CSP – Velvet Chainsaw Consulting ### 542411###Moderator###Vice President, Professional Connexity###Velvet Chainsaw Consulting###Moderator: – Velvet Chainsaw Consulting
### 9:45 AM – 11:00 AM MST
Clinical Trial Design and Alternative Data Sources
9:45 AM – 11:00 AM MST
Enhancing Diversity in Clinical Trial Populations – The Evolving Regulatory Landscape, Perspectives, and Practical Strategies to Lead ChangeLocation/Room:W104 A-BModerator: – Office of Medical Policy, FDA
Session Leader/Speaker: – Pfizer
Speaker: – Pfizer
Speaker (Remote): – Health Canada
Speaker (Remote): – Food and Drug Administration
Biopharmaceuticals
Session Room Sponsored By
Mathilda Fienkeng, PharmD, MS, RAC, CDR USPHS – Office of Medical Policy, FDA ### 1615715###Moderator###Division Director###Office of Medical Policy, FDA###Moderator: – Office of Medical Policy, FDA
### @@@ Monique Carter, MS,RAC – Pfizer ### 720633###Session Leader/Speaker###Senior Director, Pfizer Global Regulatory Affairs - Internal Medicine###Pfizer###Session Leader/Speaker: – Pfizer
### @@@ Zaida Recinos-Vasquez, MS, MS – Pfizer ### 1615708###Speaker###Global CMC Manager###Pfizer###Speaker: – Pfizer
### @@@ Alysha Croker, PhD – Health Canada ### 1728926###Speaker (Remote)###Director, Centre for Policy, Pediatrics and International Collaboration###Health Canada###Speaker (Remote): – Health Canada
### @@@ Lola Fashoyin-Aje, MD, MPH – Food and Drug Administration ### 1728927###Speaker (Remote)###Deputy Division Director, OND/CDER
Associate Directory, Oncology Center of Excellence###Food and Drug Administration###Speaker (Remote): – Food and Drug Administration
###
9:45 AM – 11:00 AM MST
Combined Session Topic: Accelerated Drug Development and Approval Through Pilot Programs and Initiatives
9:45 AM – 11:00 AM MST
FDA and Industry Perspectives on the OCE Initiatives to Optimize Oncology Drug Development and ReviewLocation/Room:W101 CSession Leader/Speaker: – Asher Biotherapeutics, Inc.
Speaker: – Hoffmann-La Roche Limited
Speaker (Remote): – US Food and Drug Administration
Speaker (Remote): – Genentech
Biopharmaceuticals
James Cross, PhD – Asher Biotherapeutics, Inc. ### 1615712###Session Leader/Speaker###Vice-President, Regulatory Affairs###Asher Biotherapeutics, Inc.###Session Leader/Speaker: – Asher Biotherapeutics, Inc.
### @@@ Grace Gao, PharmD – Hoffmann-La Roche Limited ### 1615706###Speaker###Program Manager, Regulatory Affairs###Hoffmann-La Roche Limited###Speaker: – Hoffmann-La Roche Limited
### @@@ Tamy Kim, PharmD – US Food and Drug Administration ### 838301###Speaker (Remote)###Director for Regulatory Affairs and Policy, Oncology Center of Excellence (OCE) and Supervisory Associate Director for Regulatory Affairs (Acting), Office of Oncologic Diseases (OOD)###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### @@@ Sarah Bentouati, MA, PharmD – Genentech ### 1766669###Speaker (Remote)###Regulatory Group Director###Genentech###Speaker (Remote): – Genentech
###
9:45 AM – 11:00 AM MST
Companion Diagnostics and Personalized Medicine
9:45 AM – 11:00 AM MST
Strategic Considerations for Navigating the Global Landscape of Companion DiagnosticsLocation/Room:W101 A-BSession Leader/Speaker: – Seagen Inc.
Speaker: – PharmaLex
Speaker: – Merck Sharp & Dohme LLC
Speaker: – Seagen Inc.
Bothell, Washington, United States
Speaker (Remote): – European Medicines Agency
In Vitro Diagnostics
Session Room Sponsored By
Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Session Leader/Speaker###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Session Leader/Speaker: – Seagen Inc.
### @@@ TJ Thiel, RAC – PharmaLex ### 1614540###Speaker###Senior Director, Medical Devices / IVD Services###PharmaLex###Speaker: – PharmaLex
### @@@ Erin K. Grath, BS, MS – Merck Sharp & Dohme LLC ### 1698213###Speaker###Senior Director###Merck Sharp & Dohme LLC###Speaker: – Merck Sharp & Dohme LLC
### @@@ Adriana Racolta, PhD, RAC – Seagen Inc.
Bothell, Washington, United States ### 1728971###Speaker###Associate Director Regulatory Affairs Companion Diagnostics###Seagen Inc.
Bothell, Washington, United States###Speaker: – Seagen Inc.
Bothell, Washington, United States
### @@@ Miguel Antunes, PharmD, MPH – European Medicines Agency ### 1778452###Speaker (Remote)###Medical Device Specialist###European Medicines Agency###Speaker (Remote): – European Medicines Agency
###
9:45 AM – 11:00 AM MST
Health Authority Forum - CBER/CDER
9:45 AM – 11:00 AM MST
Health Authority Forum - CBER/CDERLocation/Room:W105 A-CSpeaker (Remote): – United States Food and Drug Administration
Speaker (Remote): – US FDA
Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
Speaker (Remote): – Office of New Drugs, CDER, FDA
Health Authority Forum
Peter W. Marks, MD, PhD – United States Food and Drug Administration ### 574711###Speaker (Remote)###Director, Center for Biologics Evaluation and Research###United States Food and Drug Administration###Speaker (Remote): – United States Food and Drug Administration
### @@@ Christopher Joneckis, PhD – US FDA ### 601550###Speaker (Remote)###Associate Director For Review Management, CBER###US FDA###Speaker (Remote): – US FDA
### @@@ Sonday L. Kelly, MS, RAC, PMP – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Moderator###Staff Director###Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration###Moderator: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Peter P. Stein, MD – Office of New Drugs, CDER, FDA ### 1379324###Speaker (Remote)###Director###Office of New Drugs, CDER, FDA###Speaker (Remote): – Office of New Drugs, CDER, FDA
###
9:45 AM – 11:00 AM MST
Improve Your Public Speaking Skills
9:45 AM – 11:00 AM MST
Improve Your Public Speaking SkillsLocation/Room:W103 A-BSpeaker: – Integrated Project Management Company, Inc.
Skill Building
Susan E. Carino, MBA, MS, PMP, RAC – Integrated Project Management Company, Inc. ### 1000086###Speaker###Principal Consultant###Integrated Project Management Company, Inc.###Speaker: – Integrated Project Management Company, Inc.
###
9:45 AM – 11:00 AM MST
Practical Implications and Changes Post Order 739 for Medical Devices and IVD in China
9:45 AM – 11:00 AM MST
Practical Implications and Changes Post Order 739 for Medical Devices and IVD in ChinaLocation/Room:W102 A-CSession Leader/Speaker: – BradyKnows Medical, LLC
Speaker: – Immucor, Inc.
Speaker: – China Med Device
Medical Devices
Session Room Sponsored By
Tracy Yu, MSc – BradyKnows Medical, LLC ### 1614534###Session Leader/Speaker###Senior Regulatory Affairs Manager###BradyKnows Medical, LLC###Session Leader/Speaker: – BradyKnows Medical, LLC
### @@@ Qianqian Zhu, MBA, LLM, RAC Global – Immucor, Inc. ### 1614529###Speaker###Director of International Regulatory Affairs###Immucor, Inc.###Speaker: – Immucor, Inc.
### @@@ Grace Palma, MBA – China Med Device ### 720651###Speaker###CEO###China Med Device###Speaker: – China Med Device
###
9:45 AM – 11:00 AM MST
Recent Developments in EU Regulations & Clinical Evaluation
9:45 AM – 11:00 AM MST
Recent Developments in EU Regulations & Clinical EvaluationLocation/Room:W106 A-BSpeaker (Remote): – Akra Team GmbH
Speaker: – (British Standards Institute) BSI
Speaker (Remote): – NAMSA
Medical Devices
Session Room Sponsored By
Markus Balkenhol – Akra Team GmbH ### 1614527###Speaker (Remote)###Senior Clinical Consultant###Akra Team GmbH###Speaker (Remote): – Akra Team GmbH
### @@@ Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI ### 1054191###Speaker###Global Head of Clinical Compliance/Clinical Physiologist###(British Standards Institute) BSI###Speaker: – (British Standards Institute) BSI
### @@@ Rachel K. Gibbs, PhD – NAMSA ### 1523468###Speaker (Remote)###Principal Regulatory Consultant###NAMSA###Speaker (Remote): – NAMSA
###
9:45 AM – 11:00 AM MST
Uncertainty and Strategies to Increase Confidence in R&D and Regulatory Decision-Making
9:45 AM – 11:00 AM MST
Uncertainty and Strategies to Increase Confidence in R&D and Regulatory Decision-makingLocation/Room:W106 CSession Leader/Speaker: – Alexion Pharmaceuticals Inc.
Speaker: – Merck & Co., Inc
Speaker (Remote):
Biopharmaceuticals
Martine Zimmermann, PharmD – Alexion Pharmaceuticals Inc. ### 1452236###Session Leader/Speaker###SVP, Head of Regulatory and R&D and Commercial Quality###Alexion Pharmaceuticals Inc.###Session Leader/Speaker: – Alexion Pharmaceuticals Inc.
### @@@ Seema S. Betigeri, PhD – Merck & Co., Inc ### 828929###Speaker###Executive Director, Global Regulatory Affairs###Merck & Co., Inc###Speaker: – Merck & Co., Inc
### @@@ Huong Huynh ### 1779249###Speaker (Remote)#########Speaker (Remote):
###
11:00 AM – 11:30 AM MST
Writing for RAPS: A Guide to Contributing to RAPS' Publications
11:00 AM – 11:30 AM MST
Writing for RAPS: A Guide to Contributing to RAPS' PublicationsLocation/Room:RAPS Store (Registration Foyer)Presenter: – Regulatory Affairs Professionals Society
Presenter: – Regulatory Affairs Professionals Society
Gloria Hall – Regulatory Affairs Professionals Society ### 1451670###Presenter###Senior Editor, Publications###Regulatory Affairs Professionals Society###Presenter: – Regulatory Affairs Professionals Society
### @@@ Renee Matthews – Regulatory Affairs Professionals Society ### 1768455###Presenter###Senior Editor, Features###Regulatory Affairs Professionals Society###Presenter: – Regulatory Affairs Professionals Society
###
11:00 AM – 4:30 PM MST
Exhibit Hall Open
11:00 AM – 4:30 PM MST
Exhibit Hall OpenLocation/Room:Exhibit Hall
11:00 AM – 4:30 PM MST
Headshot Lounge
11:00 AM – 4:30 PM MST
Headshot Lounge
Location/Room:Exhibit Hall: Booth 939
11:15 AM – 11:40 AM MST
Accelerate Trust in Healthcare Patient Verification
11:15 AM – 11:40 AM MST
Accelerate Trust in Healthcare Patient VerificationLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – Shufti Pro Limited
Patrick Kelly – Shufti Pro Limited ### 1756308###Speaker###Head of Americas Sales###Shufti Pro Limited###Speaker: – Shufti Pro Limited
###
11:15 AM – 11:40 AM MST
Benefits of Implementing an End-to-End Regulatory Information Management Platform
11:15 AM – 11:40 AM MST
Benefits of Implementing an End-to-End Regulatory Information Management PlatformLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Kathie Clark – Ennov ### 1756307###Speaker###Director, Product Management###Ennov###Speaker: – Ennov
###
11:15 AM – 11:45 AM MST
Solutions Circle: An insight into MDR Technical Documentation auditing - Improving submissions to your Notified Body
11:15 AM – 11:45 AM MST
Solutions Circle: Improving MDR Technical Documentation Submissions to Your Notified BodyLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Paul John Risborough, BEng Hons – NAMSA ### 1441663###Speaker###Principal Regulatory Consultant ###NAMSA###Speaker: – NAMSA
### 11:15 AM – 11:45 AM MST
Solutions Circle: Global Label Management and Automation
11:15 AM – 11:45 AM MST
Solutions Circle: Global Label Management and AutomationLocation/Room:Exhibit Hall: Booth 104Speaker: – PwC
Speaker: – PwC
Speaker: – PwC
Solutions Circle
Megha Sinha, MS, RAC – PwC ### 1615742###Speaker###Director###PwC###Speaker: – PwC
### @@@ Zhi Chai, MBA – PwC ### 1615686###Speaker###Senior Associate###PwC###Speaker: – PwC
### @@@ Nidhi Singh – PwC ### 1753092###Speaker###Sr Associate###PwC###Speaker: – PwC
###
11:15 AM – 11:45 AM MST
Solutions Circle: Regulatory Challenges of Augmented Reality
11:15 AM – 11:45 AM MST
Solutions Circle: Regulatory Challenges of Novel Technology Location/Room:Exhibit Hall: Booth 104Speaker: – MediView XR
Speaker: – MediView XR, Inc.
Solutions Circle
Adam S. Cargill, MS, RAC-US – MediView XR ### 1614398###Speaker###Director, QA/RA/CA###MediView XR###Speaker: – MediView XR
### @@@ Crew J. Weunski, M.S. – MediView XR, Inc. ### 1632165###Speaker###Quality & Regulatory Specialist###MediView XR, Inc.###Speaker: – MediView XR, Inc.
###
11:15 AM – 11:45 AM MST
Solutions Circle: The Top 10 483s: A Trip Through History
11:15 AM – 11:45 AM MST
Solutions Circle: The Top 10 483s: a Trip Through HistoryLocation/Room:Exhibit Hall: Booth 104Speaker: – Compliance Team, LLC
Solutions Circle
Regina M. Fullin, Compliance Team, LLC – Compliance Team, LLC ### 1615664###Speaker###V.P. of RA/QA###Compliance Team, LLC###Speaker: – Compliance Team, LLC
### 11:30 AM – 12:30 PM MST
Chapter Meet and Greets
11:30 AM – 12:30 PM MST
Chapter Meet and GreetsLocation/Room:Exhibit Hall: Booth 728
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit Hall
11:30 AM – 1:30 PM MST
Networking Lunch in Exhibit HallLocation/Room:Exhibit Hall
11:45 AM – 12:10 PM MST
Your Next Career Path...Regulatory Affairs Consulting
11:45 AM – 12:10 PM MST
Your Next Career Path...Regulatory Affairs ConsultingLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Lindsey Regulatory Affairs Consulting, LLC
Sequita Lindsey, RAC – Lindsey Regulatory Affairs Consulting, LLC ### 1756313###Speaker###President and CEO###Lindsey Regulatory Affairs Consulting, LLC###Speaker: – Lindsey Regulatory Affairs Consulting, LLC
###
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Critical CMC Requirements in the Approval of CAR T Cell Products
11:45 AM – 12:15 PM MST
Student Capstone Showcase Presentation: Critical CMC Requirements in the Approval of CAR T Cell ProductsLocation/Room:Exhibit Hall: Career Central, Booth 728Speaker: – University of Southern California
Alberto Fernandez – University of Southern California ### 1764974###Speaker###Student###University of Southern California###Speaker: – University of Southern California
###
11:45 AM – 12:30 PM MST
Board of Directors Meet and Greets
11:45 AM – 12:30 PM MST
Board of Directors Meet and GreetsLocation/Room:Exhibit Hall: Booth 413
12:00 PM – 12:30 PM MST
Solutions Circle: Ethylene Oxide Sterilization: FDA/EPA order to Reduce EtO Use and Protect the Supply Chain
12:00 PM – 12:30 PM MST
Solutions Circle: Ethylene Oxide Sterilization: FDA/EPA Order to Reduce Eto Use and Protect the Supply ChainLocation/Room:Exhibit Hall: Booth 104Speaker: – Boston Scientific - ENTERPRISE
Solutions Circle
Mac McKeen, RAC FRAPS MBA – Boston Scientific - ENTERPRISE ### 772303###Speaker###Fellow, Regulatory Science###Boston Scientific - ENTERPRISE###Speaker: – Boston Scientific - ENTERPRISE
### 12:00 PM – 12:30 PM MST
Solutions Circle: Maximizing the potential of the FDA assessment aid
12:00 PM – 12:30 PM MST
Solutions Circle: Maximizing the Potential of the FDA Assessment AidLocation/Room:Exhibit Hall: Booth 104Speaker: – Hoffman-La Roche Limited
Solutions Circle
Lawrence Giraudi, MSc. – Hoffman-La Roche Limited ### 1615684###Speaker###Senior Director, Regulatory Documentation###Hoffman-La Roche Limited###Speaker: – Hoffman-La Roche Limited
### 12:00 PM – 12:30 PM MST
Solutions Circle: Overview of Global E-labeling
12:00 PM – 12:30 PM MST
Solutions Circle: Overview of Global E-labelingLocation/Room:Exhibit Hall: Booth 104Speaker: – PwC
Speaker: – PwC
Speaker: – PwC
Solutions Circle
Zhi Chai, MBA – PwC ### 1615686###Speaker###Senior Associate###PwC###Speaker: – PwC
### @@@ Daniel Lozano – PwC ### 1615743###Speaker###Manager###PwC###Speaker: – PwC
### @@@ Steven Spencer – PwC ### 1753093###Speaker###Experienced Associate###PwC###Speaker: – PwC
### 12:00 PM – 12:30 PM MST
Solutions Circle: Types of Types and Types .. er, is that a Typo?
12:00 PM – 12:30 PM MST
Solutions Circle: Types of Types and Types .. Er, Is That a Typo?Location/Room:Exhibit Hall: Booth 104Solutions Circle
Keith Morel, PhD – Qserve ### 535522###Speaker###VP Regulatory Compliance###Qserve###Speaker: – Qserve
###
12:20 PM – 12:45 PM MST
Comparative Analysis of Approvals in Oncology, With and Without Project Orbis
12:20 PM – 12:45 PM MST
Comparative Analysis of Approvals in Oncology, With and Without Project OrbisLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Sheila Galan – Cedience ### 1761481###Speaker###Head of Quality & Regulatory Sciences###Cedience###Speaker: – Cedience
###
12:20 PM – 12:45 PM MST
EU MDR Class I … not so simple.
12:20 PM – 12:45 PM MST
EU MDR Class I … not so simple.Location/Room:Exhibit Hall: Ignite! Stage - Booth 337Presenter: – Fang Consulting
Heather Kurtz – Fang Consulting ### 1771194###Presenter###Senior Regulatory Affairs Consultant###Fang Consulting###Presenter: – Fang Consulting
###
12:30 PM – 1:00 PM MST
Career Central Presentation: Insights from the RAPS 2022 Global Compensation and Scope of Practice Report
12:30 PM – 1:00 PM MST
Career Central Presentation: Insights from the RAPS 2022 Global Compensation and Scope of Practice Report Location/Room:Exhibit Hall: Booth 728
Denise Fulton – RAPS ### 1083162###Presenter###Vice President, Research & Content Strategy###RAPS###Presenter: – RAPS
###
12:45 PM – 1:15 PM MST
Regulatory Focus Meet Up
12:45 PM – 1:15 PM MST
Regulatory Focus Meet UpLocation/Room:Exhibit Hall: Booth 413
12:45 PM – 1:15 PM MST
Meet the Authors: Fundamentals of Medical Device Regulations, Fifth Edition by Gert Bos and Jocelyn Jennings
12:45 PM – 1:15 PM MST
Meet the Authors: Fundamentals of Medical Device Regulations, Fifth Edition by Gert Bos and Jocelyn JenningsLocation/Room:RAPS Store (Registration Foyer)
12:45 PM – 1:15 PM MST
Solutions Circle: Developing IVDR Compliant Intended Purpose Statements That Serve the Business and Meet Notified Body Expectations
12:45 PM – 1:15 PM MST
Solutions Circle: Developing IVDR Compliant Intended Purpose Statements That Serve the Business and Meet Notified Body ExpectationsLocation/Room:Exhibit Hall: Booth 104Speaker: – RQM+
Speaker: – RQM+
Solutions Circle
Carlos Galamba – RQM+ ### 1523600###Speaker###Vice President IVD, Intelligence & Innovation###RQM+###Speaker: – RQM+
### @@@ Celeste Ann Maksim, PhD – RQM+ ### 1092278###Speaker###Chief of Staff, Clinical & Post-Market Practice###RQM+###Speaker: – RQM+
###
12:45 PM – 1:15 PM MST
Solutions Circle: Kits & Procedure Packs - Ranging from Easy to Impossible
12:45 PM – 1:15 PM MST
Solutions Circle: Kits & Procedure Packs - Ranging from Easy to ImpossibleLocation/Room:Exhibit Hall: Booth 104Speaker: – Qserve Group
Speaker: – Qserve Group
Solutions Circle
Mindy McCann – Qserve Group ### 720640###Speaker###VP Regulatory Compliance###Qserve Group###Speaker: – Qserve Group
### @@@ Christie Hughes, MPH, MLS(ASCP) – Qserve Group ### 1389439###Speaker###Principal Consultant, QA/RA and IVD Expert###Qserve Group###Speaker: – Qserve Group
### 12:45 PM – 1:15 PM MST
Solutions Circle: Role of Prescription Drug Labeling in Minimizing Medication Errors
12:45 PM – 1:15 PM MST
Solutions Circle: Role of Prescription Drug Labeling in Minimizing Medication ErrorsLocation/Room:Exhibit Hall: Booth 104Speaker: – Opus Regulatory
Solutions Circle
Kamana Singh, BVSc, MVSc, PSM-MMB, MBA, RAC(US) – Opus Regulatory ### 1615685###Speaker###Principal Regulatory Consultant###Opus Regulatory###Speaker: – Opus Regulatory
###
12:45 PM – 1:15 PM MST
Solutions Circle: Strategic Down Classification of a PMA Accessory
12:45 PM – 1:15 PM MST
Solutions Circle: Strategic Down Classification of a PMA AccessoryLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Brian Godwin, RAC – Ethicon ### 1614393###Speaker###Associater Director, Regulatory Affairs###Ethicon###Speaker: – Ethicon
### 12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring"
12:45 PM – 1:45 PM MST
RAPS Fellows "Speed Mentoring"
Location/Room:Exhibit Hall: Booth 728
12:55 PM – 1:20 PM MST
2023 Outlook for the European Market
12:55 PM – 1:20 PM MST
2023 Outlook for the European MarketLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337
Evangeline Loh, Ph.D., RAC (US, EU) – Emergo by UL ### 1773497###Speaker###Manager, Quality & Regulatory Affairs###Emergo by UL###Speaker: – Emergo by UL
###
12:55 PM – 1:20 PM MST
7 Deadly Sins of Product Compliance
12:55 PM – 1:20 PM MST
7 Deadly Sins of Product ComplianceLocation/Room:Exhibit Hall: Spark! Stage - Booth 215
Travis Miller – Assent ### 1773541###Speaker###General Counsel###Assent###Speaker: – Assent
###
1:15 PM – 1:45 PM MST
Career Central Presentation: RAPS Code of Ethics for the Regulatory Profession
1:15 PM – 1:45 PM MST
Career Central Presentation: RAPS Code of Ethics for the Regulatory ProfessionLocation/Room:Exhibit Hall: Booth 728Presenter: – CM Cooper & Associates
Carol M. Cooper, MS, RAC, IM(ASCP), RM(AAM) – CM Cooper & Associates ### 1630469###Presenter###Principal###CM Cooper & Associates###Presenter: – CM Cooper & Associates
###
1:30 PM – 1:55 PM MST
Can AI be Safe in Medical Devices?: Shaping the Future with the Cloud and Open Source Software
1:30 PM – 1:55 PM MST
Can AI be Safe in Medical Devices?: Shaping the Future with the Cloud and Open Source SoftwareLocation/Room:Exhibit Hall: Spark! Stage - Booth 215Speaker: – Ketryx Corporation
Erez Kaminski, MS, MBA – Ketryx Corporation ### 1764635###Speaker###Founder and CEO###Ketryx Corporation###Speaker: – Ketryx Corporation
###
1:30 PM – 1:55 PM MST
The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success
1:30 PM – 1:55 PM MST
The Role of RA in the Clinical and Performance Evaluation Process: Key Strategies to Support Project SuccessLocation/Room:Exhibit Hall: Ignite! Stage - Booth 337Speaker: – Criterion Edge
Laurie Mitchell – Criterion Edge ### 1634261###Speaker###President###Criterion Edge###Speaker: – Criterion Edge
###
1:30 PM – 2:00 PM MST
Solutions Circle: Clinical Investigations Using FDA Consensus EU Harmonised ISO 14155:2020 - Changes from 2011
1:30 PM – 2:00 PM MST
Solutions Circle: Clinical Investigations Using FDA Consensus EU Harmonised ISO 14155:2020 - Changes from 2011Location/Room:Exhibit Hall: Booth 104Speaker: – SG Consulting-Pro Ltd.
Solutions Circle
Sharon Goldfarb – SG Consulting-Pro Ltd. ### 1614382###Speaker###Ceo/Consultant###SG Consulting-Pro Ltd.###Speaker: – SG Consulting-Pro Ltd.
### 1:30 PM – 2:00 PM MST
Solutions Circle: How to Efficiently Prepare Your eSTAR Submission
1:30 PM – 2:00 PM MST
Solutions Circle: How to Efficiently Prepare Your Estar SubmissionLocation/Room:Exhibit Hall: Booth 104Solutions Circle
Anike Freeman, M.Eng. – RQM+ ### 1614396###Speaker###Principal Consultant###RQM+###Speaker: – RQM+
### 1:30 PM – 2:00 PM MST
Solutions Circle: Partnering with the FDA: The Q-Submission Solution
1:30 PM – 2:00 PM MST
Solutions Circle: Partnering with the FDA: The Q-submission SolutionLocation/Room:Exhibit Hall: Booth 104Speaker: – Network Partners
Solutions Circle
Amy Winegarden – Network Partners ### 1636771###Speaker###Associate Director, Regulatory Affairs###Network Partners###Speaker: – Network Partners
### 1:30 PM – 2:00 PM MST
Solutions Circle: Potential Pitfalls of Orphan Drug Designation Requests
1:30 PM – 2:00 PM MST
Solutions Circle: Potential Pitfalls of Orphan Drug Designation RequestsLocation/Room:Exhibit Hall: Booth 104Speaker: – Premier Consulting
Solutions Circle
Jennifer L. Fielder – Premier Consulting ### 1615687###Speaker###Regulatory Compliance Manager###Premier Consulting###Speaker: – Premier Consulting
### 2:00 PM – 3:00 PM MST
Accelerated Drug Development & Approval through Pilot Programs and Initiatives
2:00 PM – 3:00 PM MST
When Everyday Counts: Global Expedited Approval Pathways for Novel TherapeuticsLocation/Room:W103 A-BSession Leader/Speaker: – Seagen Inc.
Speaker: – PharmaLex
Speaker: – Genentech, a member of the Roche Group
Speaker: – European Medicines Agency
Biopharmaceuticals
Linda Bowen, MSc, RAC, FRAPS – Seagen Inc. ### 1615689###Session Leader/Speaker###Head of Global Regulatory Policy and Intelligence###Seagen Inc.###Session Leader/Speaker: – Seagen Inc.
### @@@ Mark Lane, MS, PhD – PharmaLex ### 1615688###Speaker###VP Development and Scientific Affairs###PharmaLex###Speaker: – PharmaLex
### @@@ Jamie L. Robinson, MBA, RAC – Genentech, a member of the Roche Group ### 535434###Speaker###Program Director, Pharma Technical Regulatory###Genentech, a member of the Roche Group###Speaker: – Genentech, a member of the Roche Group
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
###
2:00 PM – 3:00 PM MST
Breaking Through New FDA Pathways: EUA and Novel Device Programs
2:00 PM – 3:00 PM MST
Breaking Through New FDA Pathways: EUA and Novel Device ProgramsLocation/Room:W101 A-BSession Leader/Speaker: – DuVal & Associates, P.A.
Speaker: – Veeva Systems
Speaker: – DuVal & Associates, P.A.
Medical Devices
Session Room Sponsored By
Lisa L. Pritchard, BSEEE – DuVal & Associates, P.A. ### 1614391###Session Leader/Speaker###VP, Regulatory, Quality, Clinical & Engineering###DuVal & Associates, P.A.###Session Leader/Speaker: – DuVal & Associates, P.A.
### @@@ Brian Scogland, MBA, MS – Veeva Systems ### 1614542###Speaker###Senior Director of Regulatory Strategy, MedTech###Veeva Systems###Speaker: – Veeva Systems
### @@@ Kathy Herzog, BSME – DuVal & Associates, P.A. ### 1614392###Speaker###Regulatory Consultant###DuVal & Associates, P.A.###Speaker: – DuVal & Associates, P.A.
###
2:00 PM – 3:00 PM MST
Conversations that Matter (Devices)
2:00 PM – 3:00 PM MST
Conversations That Matter (Devices)Location/Room:W105 A-BModerator:
Moderator:
Speaker: – Health Canada
Speaker: – European Medicines Agency
Speaker: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
Speaker: – US Food & Drug Administration / CBER
Speaker: – TÜV SÜD Medical Health Services
Speaker (Remote): – FDA/CDRH
Speaker (Remote): – US Food and Drug Administration
Conversations That Matter
Susan Stewart ### 1698805###Moderator#########Moderator:
### @@@ Jethro Ekuta ### 1698806###Moderator#########Moderator:
### @@@ David Boudreau, ing – Health Canada ### 570151###Speaker###Director General###Health Canada###Speaker: – Health Canada
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Sonday L. Kelly, MS, RAC, PMP – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration ### 1679212###Speaker###Staff Director###Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration###Speaker: – Regulatory Project Management Staff / Office of Blood Research and Review / Center for Biologics Evaluation and Research / Food and Drug Administration
### @@@ Katherine Kim, MPH, RAC, CQA – US Food & Drug Administration / CBER ### 1728974###Speaker###Acting Senior Advisor for Medical Device###US Food & Drug Administration / CBER###Speaker: – US Food & Drug Administration / CBER
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Speaker: – TÜV SÜD Medical Health Services
### @@@ Ken Skodacek – FDA/CDRH ### 1005446###Speaker (Remote)###FDA/CDRH Deputy Ombudsman###FDA/CDRH###Speaker (Remote): – FDA/CDRH
### @@@ Eli Tomar, JD, MPH – US Food and Drug Administration ### 1083197###Speaker (Remote)###Associate Director for Guidance, Legislation and Special Projects, Office of Policy, CDRH###US Food and Drug Administration###Speaker (Remote): – US Food and Drug Administration
### 2:00 PM – 3:00 PM MST
Decentralized Clinical Trials: What Are Clinical Trials Like Today?
2:00 PM – 3:00 PM MST
Decentralized Clinical Trials: What Are Clinical Trials Like Today?Location/Room:W106 CSession Leader/Speaker: – Biotechnology innovation organization
Speaker: – Bayer Pharma
Speaker: – Janssen
Biopharmaceuticals
Leslie Harden, PharmD – Biotechnology innovation organization ### 1615668###Session Leader/Speaker###Director###Biotechnology innovation organization###Session Leader/Speaker: – Biotechnology innovation organization
### @@@ Sumana Biswas, PhD – Bayer Pharma ### 1698209###Speaker###US Head, RA Strategy, Cardio-Renal###Bayer Pharma###Speaker: – Bayer Pharma
### @@@ Danielle Friend – Janssen ### 1698210###Speaker###Director, Regulatory Policy and Intelligence###Janssen###Speaker: – Janssen
###
2:00 PM – 3:00 PM MST
ICH a Unique Platform for Convergence & Collaboration
2:00 PM – 3:00 PM MST
ICH a Unique Platform for Convergence & CollaborationLocation/Room:W104 A-BSession Leader/Speaker: – Merck (EMD Serono in the US)
Speaker (Remote): – FDA/Center for Drug Evaluation and Research
Speaker (Remote): – Health Canada
Biopharmaceuticals
Session Room Sponsored By
Isabelle Colmagne-Poulard, PhD Pharmacy, MBA – Merck (EMD Serono in the US) ### 1321690###Session Leader/Speaker###Director, International Global Regulatory Affairs & Scientific Policy (GRASP)###Merck (EMD Serono in the US)###Session Leader/Speaker: – Merck (EMD Serono in the US)
### @@@ Ashley Boam, BSE, MSBE – FDA/Center for Drug Evaluation and Research ### 1728952###Speaker (Remote)###Director, Office of Policy for Pharmaceutical Quality###FDA/Center for Drug Evaluation and Research###Speaker (Remote): – FDA/Center for Drug Evaluation and Research
### @@@ Bruce Randall, B. Sc – Health Canada ### 1402493###Speaker (Remote)###Senior Executive Director###Health Canada###Speaker (Remote): – Health Canada
###
2:00 PM – 3:00 PM MST
Plain Language and Lay Language Summaries: Overview and Writing
2:00 PM – 3:00 PM MST
Plain Language and Lay Language Summaries: Overview and WritingLocation/Room:W101 CSession Leader/Speaker: – Certara
Broad Interest
Laura Sheppard, MBA, MA – Certara ### 1615669###Session Leader/Speaker###Senior Director, Global Submissions and Plain Language Summary Lead###Certara###Session Leader/Speaker: – Certara
###
2:00 PM – 3:00 PM MST
Regulatory challenges and Implications of UK and Switzerland leaving the EU
2:00 PM – 3:00 PM MST
Regulatory Challenges and Implications of UK and Switzerland Leaving the EULocation/Room:W106 A-BSession Leader/Speaker: – Abbott
Speaker: – BSI Group
Speaker (Remote): – Swissmedic, Division Medical Devices Surveillance
Medical Devices
Session Room Sponsored By
Amra Racic – Abbott ### 1614546###Session Leader/Speaker###Director RIS###Abbott###Session Leader/Speaker: – Abbott
### @@@ Vishal Thakker, MEng – BSI Group ### 1614543###Speaker###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Speaker: – BSI Group
### @@@ Michael Köhli, PhD – Swissmedic, Division Medical Devices Surveillance ### 1671525###Speaker (Remote)###Head of section MDS1###Swissmedic, Division Medical Devices Surveillance ###Speaker (Remote): – Swissmedic, Division Medical Devices Surveillance
###
2:00 PM – 3:00 PM MST
Safety in EU Medical Device Clinical Trials: Best Practices for Compliance and Inspection Readiness
2:00 PM – 3:00 PM MST
Safety in EU Medical Device Clinical Trials: Best Practices for Compliance and Inspection ReadinessLocation/Room:W102 A-CSpeaker: – Meditrial USA Inc.
Speaker: – AGES (Austrian Agency for Health & Food Safety)
Speaker: – Meditrial
Moderator: – Self Employed
Speaker: – Meditrial GmbH
Medical Devices
Session Room Sponsored By
Monica Tocchi, MD – Meditrial USA Inc. ### 1614387###Speaker###Chief Medical Officer###Meditrial USA Inc.###Speaker: – Meditrial USA Inc.
### @@@ Karl-Heinz Huemer, MD, PhD – AGES (Austrian Agency for Health & Food Safety) ### 573393###Speaker###Medical Assessor###AGES (Austrian Agency for Health & Food Safety)###Speaker: – AGES (Austrian Agency for Health & Food Safety)
### @@@ Debra Kridner, MA – Meditrial ### 1776778###Speaker###Executive in Regulatory, Quality and Clinical###Meditrial ###Speaker: – Meditrial
### @@@ Vicki Bebeau, BSN – Self Employed ### 1614390###Moderator###Clinical Advisor###Self Employed###Moderator: – Self Employed
### @@@ Kristin Forßmann, MD – Meditrial GmbH ### 1670172###Speaker###Director Clinical Development###Meditrial GmbH###Speaker: – Meditrial GmbH
###
2:00 PM – 4:00 PM MST
Resume Reviews and Career Coaching
2:00 PM – 4:00 PM MST
Resume Reviews and Career CoachingLocation/Room:Exhibit Hall: Booth 728
3:00 PM – 3:30 PM MST
Coffee & Refreshment Break
3:00 PM – 3:30 PM MST
Coffee & Refreshment BreakLocation/Room:Session Rooms: W101-106 Foyers
3:30 PM – 4:30 PM MST
Adapting a Regulatory Framework for Personalized Devices
3:30 PM – 4:30 PM MST
Adapting a Regulatory Framework for Personalized DevicesLocation/Room:W102 A-CSession Leader/Speaker: – Philips Healthcare
Speaker: – Ricoh USA
Speaker: – Optum
Medical Devices
Session Room Sponsored By
Meg Mucha, RAC, FRAP – Philips Healthcare ### 1614524###Session Leader/Speaker###Director###Philips Healthcare###Session Leader/Speaker: – Philips Healthcare
### @@@ Scott Brewer – Ricoh USA ### 1614525###Speaker###Senior Manager, Regulatory Compliance - Additive Manufacturing###Ricoh USA###Speaker: – Ricoh USA
### @@@ Tracey Fox, MS, RAC – Optum ### 535448###Speaker###Sr. Director, Regulatory Affairs###Optum###Speaker: – Optum
###
3:30 PM – 4:30 PM MST
Combination Products: Perspectives from Drug/biologics and Device Industries
3:30 PM – 4:30 PM MST
Combination Products: Perspectives from Drug/biologics and Device IndustriesLocation/Room:W106 CSession Leader/Speaker: – NSF International, Health Sciences Division
Speaker: – Hyman, Phelps & McNamara, P.C.
Moderator: – Quidel
Biopharmaceuticals
Andy Papas, PhD, MBA – NSF International, Health Sciences Division ### 1615716###Session Leader/Speaker###Vice President of Regulatory Affairs###NSF International, Health Sciences Division###Session Leader/Speaker: – NSF International, Health Sciences Division
### @@@ Adrienne Lenz, MS, RAC – Hyman, Phelps & McNamara, P.C. ### 535486###Speaker###Principal Medical Device Regulatory Expert###Hyman, Phelps & McNamara, P.C.###Speaker: – Hyman, Phelps & McNamara, P.C.
### @@@ Frank Pokrop, RAC, CQE, CSQE, CPGP, CISA – Quidel ### 1642067###Moderator###Sr. Director, Reg. Affairs###Quidel###Moderator: – Quidel
###
3:30 PM – 4:30 PM MST
eCTD 4.0 - No Need to be afraid
3:30 PM – 4:30 PM MST
Ectd 4.0 - No Need to Be AfraidLocation/Room:W101 A-BSession Leader/Speaker: – EXTEDO GmbH
Skill Building
Session Room Sponsored By
Frank Dickert – EXTEDO GmbH ### 1321687###Session Leader/Speaker###Senior Business Consultant###EXTEDO GmbH###Session Leader/Speaker: – EXTEDO GmbH
###
3:30 PM – 4:30 PM MST
Health Authority Forum
3:30 PM – 4:30 PM MST
Health Authority Forum - JapanLocation/Room:W105 A-CModerator: – Cook Medical
Speaker: – PMDA
Speaker: – Pharmaceuticals and Medical Devices Agency
Health Authority Forum
David Chadwick, PhD, RAC, FRAPS – Cook Medical ### 549204###Moderator###Director, Regulatory Affairs / Regulatory Science###Cook Medical###Moderator: – Cook Medical
### @@@ Kuniki Imagawa, MSc – PMDA ### 1614535###Speaker###Principal Officer, Office of Standards and Compliance for Medical Devices###PMDA###Speaker: – PMDA
### @@@ Haruko Yamamoto, MD, PhD – Pharmaceuticals and Medical Devices Agency ### 1688377###Speaker###Associate Executive Director###Pharmaceuticals and Medical Devices Agency###Speaker: – Pharmaceuticals and Medical Devices Agency
###
3:30 PM – 4:30 PM MST
Real-World Evidence: Current Global Landscape and utility in Regulatory Decision-Making
3:30 PM – 4:30 PM MST
Real-World Evidence: Current Global Landscape and Utility in Regulatory Decision-makingLocation/Room:W103 A-BSession Leader/Speaker: – Merck & Co., Inc
Speaker: – Bristol Myers Squibb
Speaker: – European Medicines Agency
Biopharmaceuticals
Seema S. Betigeri, PhD – Merck & Co., Inc ### 828929###Session Leader/Speaker###Executive Director, Global Regulatory Affairs###Merck & Co., Inc###Session Leader/Speaker: – Merck & Co., Inc
### @@@ Rob Kalesnik-Orszulak, PharmD – Bristol Myers Squibb ### 1321696###Speaker###Director, Regulatory Innovation Lead for RWE and Data Science###Bristol Myers Squibb###Speaker: – Bristol Myers Squibb
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Speaker###Principal Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
###
3:30 PM – 4:30 PM MST
Risk Management & Clinical Evaluation
3:30 PM – 4:30 PM MST
Meaningful Conversations about Benefit Risk Analysis – A Panel DiscussionLocation/Room:W101 CSession Leader/Speaker: – Qserve Group
Speaker (Remote): – AKRA Team GmbH
Speaker: – NAMSA
Speaker: – (British Standards Institute) BSI
Medical Devices
Mindy McCann – Qserve Group ### 720640###Session Leader/Speaker###VP Regulatory Compliance###Qserve Group###Session Leader/Speaker: – Qserve Group
### @@@ Fabienne Neibecker, PhD – AKRA Team GmbH ### 1614528###Speaker (Remote)###Senior Consultant###AKRA Team GmbH###Speaker (Remote): – AKRA Team GmbH
### @@@ Matt Royle, PhD – NAMSA ### 907121###Speaker###Principal Regulatory Consultant###NAMSA###Speaker: – NAMSA
### @@@ Richard G. Holborow, Medical/Professional – (British Standards Institute) BSI ### 1054191###Speaker###Global Head of Clinical Compliance/Clinical Physiologist###(British Standards Institute) BSI###Speaker: – (British Standards Institute) BSI
###
3:30 PM – 4:30 PM MST
The Future of Patient Experience Data in Global Drug Development: EMA, FDA, and Industry Views
3:30 PM – 4:30 PM MST
The Future of Patient Experience Data in Global Drug Development: EMA, FDA, and Industry ViewsLocation/Room:W104 A-BSpeaker (Remote): – FDA
Moderator: – Bayer
Speaker: – Biotechnology innovation organization
Speaker (Remote): – European Medicines Agency
Speaker: – European Medicines Agency
Speaker (Remote): – TSC Alliance
Biopharmaceuticals
Session Room Sponsored By
Robyn Bent – FDA ### 1724460###Speaker (Remote)###FDA/CDER/OCD, Supervisory General Health Scientist###FDA###Speaker (Remote): – FDA
### @@@ Kim Quaintance-Lunn – Bayer ### 1698208###Moderator###VP, US Regulatory Lead###Bayer###Moderator: – Bayer
### @@@ Leslie Harden, PharmD – Biotechnology innovation organization ### 1615668###Speaker###Director###Biotechnology innovation organization###Speaker: – Biotechnology innovation organization
### @@@ Juan Garcia Burgos, MD – European Medicines Agency ### 1551387###Speaker (Remote)###Head of Public and Stakeholders Engagement Department###European Medicines Agency###Speaker (Remote): – European Medicines Agency
### @@@ Anabela Marcal – European Medicines Agency ### 1061464###Speaker###EMA Liaison Official to FDA###European Medicines Agency###Speaker: – European Medicines Agency
### @@@ Gabrielle Rushing, PhD – TSC Alliance ### 1778869###Speaker (Remote)###Director, Research###TSC Alliance###Speaker (Remote): – TSC Alliance
###
3:30 PM – 4:30 PM MST
With All Due Respect, We Disagree with FDA’s Assessment – Resolving Differences During Pre-Market Review
3:30 PM – 4:30 PM MST
With All Due Respect, We Disagree with FDA’s Assessment – Resolving Disagreements During Pre-market Review – Insights from Fda's Ombudsman ProgramsLocation/Room:W106 A-BSpeaker (Remote): – FDA/CDRH
Speaker (Remote): – Center for Biologics Evaluation and Research, US FDA
Speaker (Remote): – Food and Drug Administration, Center for Drug Evaluation and Research
Speaker (Remote): – USFDA Office of Regulatory Affairs (ORA)
Moderator: – Thermo Fisher Scientific
Devices & Pharmaceuticals
Session Room Sponsored By
Ken Skodacek – FDA/CDRH ### 1005446###Speaker (Remote)###FDA/CDRH Deputy Ombudsman###FDA/CDRH###Speaker (Remote): – FDA/CDRH
### @@@ Sheryl Lard-Whiteford, PhD – Center for Biologics Evaluation and Research, US FDA ### 1679217###Speaker (Remote)###Associate Director for Product Management###Center for Biologics Evaluation and Research, US FDA###Speaker (Remote): – Center for Biologics Evaluation and Research, US FDA
### @@@ Virginia Behr – Food and Drug Administration, Center for Drug Evaluation and Research ### 1728964###Speaker (Remote)###Ombuds###Food and Drug Administration, Center for Drug Evaluation and Research###Speaker (Remote): – Food and Drug Administration, Center for Drug Evaluation and Research
### @@@ Erica Katherine, MS – USFDA Office of Regulatory Affairs (ORA) ### 1768449###Speaker (Remote)###ORA Ombudsman###USFDA Office of Regulatory Affairs (ORA)###Speaker (Remote): – USFDA Office of Regulatory Affairs (ORA)
### @@@ Megha Deviprasad Iyer, MS, RAC – Thermo Fisher Scientific ### 1083158###Moderator###Global Director, Regulatory Affairs###Thermo Fisher Scientific###Moderator: – Thermo Fisher Scientific
### 4:35 PM – 5:30 PM MST
Advanced/Innovative Manufacturing: A Panel Discussion about Benefits, Challenges, and the Current Regulatory Landscape
4:35 PM – 5:30 PM MST
Advanced/innovative Manufacturing: A Panel Discussion About Benefits, Challenges, and the Current Regulatory LandscapeLocation/Room:W104 A-BSession Leader/Speaker: – Biotechnology Innovation Organization
Speaker: – Biogen
Speaker: – GSK
Speaker (Remote): – OBP/OPQ/CDER/FDA
Biopharmaceuticals
Session Room Sponsored By
Alex May, M.S. – Biotechnology Innovation Organization ### 1615691###Session Leader/Speaker###Director, Science & Regulatory ###Biotechnology Innovation Organization###Session Leader/Speaker: – Biotechnology Innovation Organization
### @@@ Kim Wolfram, MS – Biogen ### 1666112###Speaker###Head of Regulatory CMC Biologics and Gene Therapy ###Biogen ###Speaker: – Biogen
### @@@ Ben Stevens, PhD, MPH – GSK ### 1666113###Speaker###Director CMC Policy and Advocacy###GSK###Speaker: – GSK
### @@@ Joel Welch, PhD – OBP/OPQ/CDER/FDA ### 1724454###Speaker (Remote)###Associate Director for Science&Biosimilar Strategy###OBP/OPQ/CDER/FDA###Speaker (Remote): – OBP/OPQ/CDER/FDA
###
4:35 PM – 5:30 PM MST
Beyond the MDR/IVDR: Medical Device Regulatory Compliance Challenges outside of the MDR and IVDR
4:35 PM – 5:30 PM MST
Beyond the MDR/IVDR: Medical Device Regulatory Compliance Challenges Outside of the MDR and IVDRLocation/Room:W106 CSession Leader/Speaker: – Qserve Group
Speaker: – Axon Lawyers
In Vitro Diagnostics
Mindy McCann – Qserve Group ### 720640###Session Leader/Speaker###VP Regulatory Compliance###Qserve Group###Session Leader/Speaker: – Qserve Group
### @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Speaker###Partner###Axon Lawyers###Speaker: – Axon Lawyers
###
4:35 PM – 5:30 PM MST
Developing Your Label for Impact while Keeping AdPromo in Mind
4:35 PM – 5:30 PM MST
Labeling Creation: Impact on Adpromo and the Importance of Cross-Functional CollaborationLocation/Room:W103 A-BSession Leader/Speaker: – Turning Point Therapeutics, Inc.
Speaker: – Genentech, Inc.
Biopharmaceuticals
Micheline Awad, MBA – Turning Point Therapeutics, Inc. ### 535432###Session Leader/Speaker###Sr. Director, Regulatory Affairs – Advertising, Promotion, and Labeling###Turning Point Therapeutics, Inc.###Session Leader/Speaker: – Turning Point Therapeutics, Inc.
### @@@ Lisa M. Kelsey, MA LMFT – Genentech, Inc. ### 1663948###Speaker###Group Director, Head of Commercial Labeling###Genentech, Inc.###Speaker: – Genentech, Inc.
###
4:35 PM – 5:30 PM MST
EUDAMED & UDI – Evolution of the EU Regulatory Landscape
4:35 PM – 5:30 PM MST
EUDAMED & UDI – Evolution of the EU Regulatory LandscapeLocation/Room:W101 A-BSession Leader/Speaker: – Boston Scientific
Speaker: – Qserve Group
Speaker: – TÜV SÜD Medical Health Services
Speaker: – Arizona State University/Center for Healthcare Delivery and Policy
Medical Devices
Session Room Sponsored By
Olga van Grol-Lawlor, MPhil – Boston Scientific ### 1534231###Session Leader/Speaker###Manager Global Regulatory Intelligence & Advocacy###Boston Scientific###Session Leader/Speaker: – Boston Scientific
### @@@ Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Speaker###CSO - CEO###Qserve Group###Speaker: – Qserve Group
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Speaker: – TÜV SÜD Medical Health Services
### @@@ Natalia Wilson, MD MPH – Arizona State University/Center for Healthcare Delivery and Policy ### 1773705###Speaker###Executive Director###Arizona State University/Center for Healthcare Delivery and Policy###Speaker: – Arizona State University/Center for Healthcare Delivery and Policy
###
4:35 PM – 5:30 PM MST
How to define the expected lifetime of a medical device & its consequences
4:35 PM – 5:30 PM MST
How to Define the Expected Lifetime of a Medical Device & Its ConsequencesLocation/Room:W102 A-CSession Leader/Speaker: – Qserve
Speaker: – Haemonetics
Speaker: – Teleflex Interventional Urology
Medical Devices
Session Room Sponsored By
Keith Morel, PhD – Qserve ### 535522###Session Leader/Speaker###VP Regulatory Compliance###Qserve###Session Leader/Speaker: – Qserve
### @@@ Eva Hellman – Haemonetics ### 1764625###Speaker###RA/CA Manager###Haemonetics###Speaker: – Haemonetics
### @@@ Louis Marcoux – Teleflex Interventional Urology ### 1764626###Speaker###Sr. Director, Regulatory Affairs###Teleflex Interventional Urology###Speaker: – Teleflex Interventional Urology
###
4:35 PM – 5:30 PM MST
OTC Monograph Modernization – Facilitating FDA & Industry Engagement
4:35 PM – 5:30 PM MST
OTC Monograph Modernization – Facilitating FDA & Industry EngagementLocation/Room:W106 A-BSession Leader/Speaker: – Haleon
Speaker (Remote): – FDA
Speaker: – Haleon
Biopharmaceuticals
Session Room Sponsored By
Erin Oliver, MS, MBA, FRAPS – Haleon ### 1007343###Session Leader/Speaker###Senior Director, Regulatory Affairs###Haleon###Session Leader/Speaker: – Haleon
### @@@ Theresa Michele, MD – FDA ### 1052818###Speaker (Remote)###Director, Office of Nonprescription Drugs###FDA###Speaker (Remote): – FDA
### @@@ Lauren Quinn, JD – Haleon ### 1729166###Speaker###Vice President US Regulatory Affairs###Haleon###Speaker: – Haleon
###
4:35 PM – 5:30 PM MST
Regulatory Intelligence SUPER Jam Session: tips and tricks and best practices too!
4:35 PM – 5:30 PM MST
Regulatory Intelligence SUPER Jam Session: Tips and Tricks and Best Practices Too!Location/Room:W101 CSpeaker: – LifeScan
Speaker: – LifeScan
Skill Building
Rosanne Middleton – LifeScan ### 1376586###Speaker###Senior Program Lead, Regulatory Policy & Intelligence###LifeScan###Speaker: – LifeScan
### @@@ Dinar Suleman, RAC – LifeScan ### 1374645###Speaker###Manager, Regulatory Policy & Intelligence###LifeScan###Speaker: – LifeScan
###
6:00 PM – 9:00 PM MST
Closing Party: Arizona Science Center
6:00 PM – 9:00 PM MST
Closing Party: Arizona Science Center Location/Room:Offsite: Arizona Science Center
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