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Full Schedule
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Tue, Mar 5
Wed, Mar 6
Thu, Mar 7
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Tuesday, March 5, 2024
7:00 AM – 4:00 PM
East Coast USA Time
Registration
7:00 AM – 4:00 PM
East Coast USA Time
Registration
Location: Foyer C/D
8:00 AM – 9:00 PM
East Coast USA Time
Preconference Workshop Breakfast
8:00 AM – 9:00 PM
East Coast USA Time
Preconference Workshop Breakfast
9:00 AM – 4:00 PM
East Coast USA Time
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
9:00 AM – 4:00 PM
East Coast USA Time
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
Location: Concourse C
Presenter:
Mayte Martinez, MSc., RAC
– Teleflex
Presenter:
William Blackmon, PMP, CSM
– Teleflex
Presenter:
Cassandra Rominski (she/her/hers)
– Teleflex
Presenter:
Divya Raman, JD, MS, PMP
– Teleflex
10:30 AM – 11:00 AM
East Coast USA Time
Preconference Workshop Coffee Break
10:30 AM – 11:00 AM
East Coast USA Time
Preconference Workshop Coffee Break
Location: Foyer B/C
12:00 PM – 1:00 PM
East Coast USA Time
Preconference Workshop Lunch
12:00 PM – 1:00 PM
East Coast USA Time
Preconference Workshop Lunch
Location: Flight Deck Restaurant
Wednesday, March 6, 2024
7:00 AM – 5:00 PM
East Coast USA Time
Registration
7:00 AM – 5:00 PM
East Coast USA Time
Registration
Location: Foyer C/D
8:00 AM – 9:00 AM
East Coast USA Time
Breakfast - Sponsored by RegASK
8:00 AM – 9:00 AM
East Coast USA Time
Breakfast - Sponsored by RegASK
Location: Foyer B/C
9:00 AM – 10:30 AM
East Coast USA Time
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
9:00 AM – 10:30 AM
East Coast USA Time
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
Location: Concourse B
Presenter:
Darin S. Oppenheimer, DRSc, FRAPS
– BD
Panelist:
Mark Levi, PhD
– RTI
Panelist:
Susumu Nozawa, RAC, FRAPS
– Siemens Healthineers
Panelist:
Timothy Pang, MA, MSc, DLSHTM (he/him/his)
– Citeline
Panelist:
Jethro E. Ekuta, DVM, PhD, RAC, FRAPS
– Alexion, AstraZeneca Rare Disease
10:30 AM – 11:00 AM
East Coast USA Time
Coffee Break - Sponsored by PRIA
10:30 AM – 11:00 AM
East Coast USA Time
Coffee Break - Sponsored by PRIA
Location: Foyer B/C
11:00 AM – 12:00 PM
East Coast USA Time
Current Insights into the FDA Premarket Landscape
11:00 AM – 12:00 PM
East Coast USA Time
Current Insights into the FDA Premarket Landscape
Location: Concourse C/D
Presenter:
Melissa Hall, MSc (she/her/hers)
– Statera Regulatory Consulting, LLC
Presenter:
Caroline Rhim, PhD
– Evera Regulatory Advisors
Medical Device/IVD
11:00 AM – 12:00 PM
East Coast USA Time
The Importance of Precedent in Developing a Regulatory Strategy
11:00 AM – 12:00 PM
East Coast USA Time
The Importance of Precedent in Developing a Regulatory Strategy
Location: Concourse B
Presenter:
Linda F. Bowen, MSc, RAC-US, RAC-EU, RAC-CDN, Fellow (she/her/hers)
– Pfizer
Pharma/Biologics
12:15 PM – 1:15 PM
East Coast USA Time
The Importance of and Preparing the Target Product Profile (TPP)
12:15 PM – 1:15 PM
East Coast USA Time
The Importance of and Preparing the Target Product Profile (TPP)
Location: Concourse B
Presenter:
Mark Levi, PhD
– RTI
Presenter:
Xi Yang, PhD, DABT (she/her/hers)
– RTI
Pharma/Biologics
12:15 PM – 1:15 PM
East Coast USA Time
Use of Standards in Medical Device Global Regulatory Strategy (Working Title)
12:15 PM – 1:15 PM
East Coast USA Time
Use of Standards in Medical Device Global Regulatory Strategy
Location: Concourse C/D
Presenter:
Susumu Nozawa, RAC, FRAPS
– Siemens Healthineers
Medical Device/IVD
1:15 PM – 2:45 PM
East Coast USA Time
Networking Lunch - Sponsored by SGS
1:15 PM – 2:45 PM
East Coast USA Time
Networking Lunch - Sponsored by SGS
Location: Foyer B/C
2:45 PM – 3:45 PM
East Coast USA Time
Global Patient Safety Teams Should Develop the Study's Target Product Profile Safety Section
2:45 PM – 3:45 PM
East Coast USA Time
Global Patient Safety Teams Should Develop the Study's Target Product Profile Safety Section
Location: Concourse B
Presenter:
Michael E. Kieffer, Pharm.D.
– Focused Consulting, Staffing, & Drug Safety, LLC
Pharma/Biologics
2:45 PM – 3:45 PM
East Coast USA Time
In Silico Trials for Device Development and Regulatory Review: Outlining the Need for Global Acceptance
2:45 PM – 3:45 PM
East Coast USA Time
In Silico Trials for Device Development and Regulatory Review: Outlining the Need for Global Acceptance
Location: Concourse C/D
Presenter:
Marc Horner, PhD
– Ansys
Medical Device/IVD
4:00 PM – 5:00 PM
East Coast USA Time
Global Orphan Drug Regulatory Frameworks
4:00 PM – 5:00 PM
East Coast USA Time
Global Orphan Drug Regulatory Frameworks
Location: Concourse B
Presenter:
Jethro E. Ekuta, DVM, PhD, RAC, FRAPS
– Alexion, AstraZeneca Rare Disease
Pharma/Biologics
4:00 PM – 5:00 PM
East Coast USA Time
In Vitro Diagnostic Medical Devices (Working Title)
4:00 PM – 5:00 PM
East Coast USA Time
In Vitro Diagnostic Medical Devices
Location: Concourse C/D
Presenter:
Joshua D. Levin, AM, PhD, RAC (device)
– ASELL LLC
Medical Device/IVD
5:00 PM – 6:00 PM
East Coast USA Time
Reception with Sponsors
5:00 PM – 6:00 PM
East Coast USA Time
Reception with Sponsors
Location: Foyer B/C
Thursday, March 7, 2024
7:00 AM – 12:00 PM
East Coast USA Time
Registration
7:00 AM – 12:00 PM
East Coast USA Time
Registration
Location: Foyer C/D
8:00 AM – 9:00 AM
East Coast USA Time
Breakfast with Sponsors
8:00 AM – 9:00 AM
East Coast USA Time
Breakfast with Sponsors
Location: Foyer B/C
9:00 AM – 10:00 AM
East Coast USA Time
Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
9:00 AM – 10:00 AM
East Coast USA Time
Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
Location: Concourse B
Presenter:
Rob Berlin, JD/MPH
– GSK
Presenter:
Rasika Kalamegham, PhD
– Genentech
Presenter:
Jeff Siegel, MD (he/him/his)
– FDA
Pharma/Biologics
9:00 AM – 10:00 AM
East Coast USA Time
How do I get/keep my IVD device on the European Market?
9:00 AM – 10:00 AM
East Coast USA Time
How Do I Get/Keep My IVD Device on the European Market?
Location: Concourse C/D
Presenter:
Stefan Burde, PhD (he/him/his)
– TÜV SÜD
Medical Device/IVD
10:00 AM – 10:30 AM
East Coast USA Time
Coffee Break with Sponsors
10:00 AM – 10:30 AM
East Coast USA Time
Coffee Break with Sponsors
Location: Foyer B/C
10:30 AM – 11:30 AM
East Coast USA Time
Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
10:30 AM – 11:30 AM
East Coast USA Time
Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
Location: Concourse C/D
Presenter:
Karen Zhou, JD, MS, RAC
– Northeastern University
Presenter:
Ginny K. Gattinger, MS, RAC
– SoftwareCPR
Medical Device/IVD
10:30 AM – 11:30 AM
East Coast USA Time
Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
10:30 AM – 11:30 AM
East Coast USA Time
Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
Location: Concourse B
Presenter:
Rob Berlin, JD/MPH
– GSK
Presenter:
Eva Temkin
Pharma/Biologics
11:45 AM – 12:45 PM
East Coast USA Time
Building Sustainable Ways of Maintaining a Solid Regulatory Strategy
11:45 AM – 12:45 PM
East Coast USA Time
Building Sustainable Ways of Maintaining a Solid Regulatory Strategy
Location: Concourse C/D
Presenter:
Amra Racic, NA
– Veeva Systems
Medical Device/IVD
11:45 AM – 12:45 PM
East Coast USA Time
Thinking Beyond Regulatory Approval: The What, Why, When, and How of Pharma Lifecycle Management
11:45 AM – 12:45 PM
East Coast USA Time
Thinking Beyond Regulatory Approval: The What, Why, When, and How of Pharma Lifecycle Management
Location: Concourse B
Presenter:
Timothy Pang, MA, MSc, DLSHTM (he/him/his)
– Citeline
Pharma/Biologics
12:45 PM – 2:15 PM
East Coast USA Time
Lunch with Sponsors
12:45 PM – 2:15 PM
East Coast USA Time
Lunch with Sponsors
Location: Foyer B/C
2:15 PM – 3:30 PM
East Coast USA Time
Closing Plenary Session: How Cybersecurity and AI Have Changed the Regulatory Strategy Environment
2:15 PM – 3:30 PM
East Coast USA Time
Closing Plenary Session: How Cybersecurity and AI Have Changed the Regulatory Strategy Environment
Location: Concourse B
Presenter:
Michelle Jump, RAC
– MedSec LLC
Presenter:
Amra Racic, NA
– Veeva Systems
