- 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
