- 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 BPresenter: – GSK
Presenter: – Genentech
Presenter: – FDA
Pharma/Biologics
Rob Berlin, JD/MPH – GSK ### 2129428###Presenter###Head US Regulatory Policy###GSK###Presenter: – GSK
### @@@ Rasika Kalamegham, PhD – Genentech ### 1370034###Presenter###Executive Director and Head, US Regulatory Policy###Genentech###Presenter: – Genentech
### @@@ Jeff Siegel, MD (he/him/his) – FDA ### 2263115###Presenter###Office Director###FDA###Presenter: – FDA
### he/him/his
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/DMedical Device/IVD
Stefan Burde, PhD (he/him/his) – TÜV SÜD ### 2129429###Presenter###Director Global Focus Team IVD###TÜV SÜD###Presenter: – TÜV SÜD
### he/him/his
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 TechnologiesLocation: Concourse C/DPresenter: – Northeastern University
Presenter: – SoftwareCPR
Medical Device/IVD
Karen Zhou, JD, MS, RAC – Northeastern University ### 2129425###Presenter###Assistant Teaching Professor###Northeastern University###Presenter: – Northeastern University
### @@@ Ginny K. Gattinger, MS, RAC – SoftwareCPR ### 2129424###Presenter###Partner-Regulatory Affairs###SoftwareCPR###Presenter: – SoftwareCPR
###
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 SoftwareLocation: Concourse BPresenter: – GSK
Presenter:
Pharma/Biologics
Rob Berlin, JD/MPH – GSK ### 2129428###Presenter###Head US Regulatory Policy###GSK###Presenter: – GSK
### @@@ Eva Temkin ### 2252883###Presenter#########Presenter:
###
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 StrategyLocation: Concourse C/DPresenter: – Veeva Systems
Medical Device/IVD
Amra Racic, NA – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###Presenter: – Veeva Systems
###
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 ManagementLocation: Concourse BPharma/Biologics
Timothy Pang, MA, MSc, DLSHTM (he/him/his) – Citeline ### 1446092###Presenter###Managing VP, Citeline Consulting and Analytics###Citeline###Presenter: – Citeline
### he/him/his
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 EnvironmentLocation: Concourse BPresenter: – MedSec LLC
Presenter: – Veeva Systems
Michelle Jump, RAC – MedSec LLC ### 1827177###Presenter###CEO###MedSec LLC###Presenter: – MedSec LLC
### @@@ Amra Racic, NA – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###Presenter: – Veeva Systems
###
