- 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
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