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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