- 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 MaintenanceLocation: Concourse CPresenter: – Teleflex
Presenter: – Teleflex
Presenter: – Teleflex
Presenter: – Teleflex
Mayte Martinez, MSc., RAC – Teleflex ### 2129430###Presenter###Sr. Regulatory Affairs Specialist###Teleflex###Presenter: – Teleflex
### @@@ William Blackmon, PMP, CSM – Teleflex ### 2188466###Presenter###Program Director###Teleflex###Presenter: – Teleflex
### @@@ Cassandra Rominski (she/her/hers) – Teleflex ### 2188467###Presenter###Principle Regulatory Affairs Specialist###Teleflex###Presenter: – Teleflex
### she/her/hers @@@ Divya Raman, JD, MS, PMP – Teleflex ### 2188465###Presenter###Head of MDR###Teleflex###Presenter: – 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 PartnerLocation: Concourse BPresenter: – BD
Panelist: – RTI
Panelist: – Siemens Healthineers
Panelist: – Citeline
Panelist: – Alexion, AstraZeneca Rare Disease
Darin S. Oppenheimer, DRSc, FRAPS – BD ### 1446090###Presenter###Vice President Regulatory Affairs###BD###Presenter: – BD
### @@@ Mark Levi, PhD – RTI ### 2129426###Panelist###Director of Regulatory Affairs###RTI###Panelist: – RTI
### @@@ Susumu Nozawa, RAC, FRAPS – Siemens Healthineers ### 1293270###Panelist###Head of Regulatory Policy - North America###Siemens Healthineers###Panelist: – Siemens Healthineers
### @@@ Timothy Pang, MA, MSc, DLSHTM (he/him/his) – Citeline ### 1446092###Panelist###Managing VP, Citeline Consulting and Analytics###Citeline###Panelist: – Citeline
### he/him/his @@@ Jethro E. Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease ### 1945996###Panelist###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Panelist: – 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 LandscapeLocation: Concourse C/DPresenter: – Statera Regulatory Consulting, LLC
Presenter: – Evera Regulatory Advisors
Medical Device/IVD
Melissa Hall, MSc (she/her/hers) – Statera Regulatory Consulting, LLC ### 2215389###Presenter###Founder and Principal Consultant###Statera Regulatory Consulting, LLC###Presenter: – Statera Regulatory Consulting, LLC
### she/her/hers @@@ Caroline Rhim, PhD – Evera Regulatory Advisors ### 2215390###Presenter###Founder and Principal Consultant###Evera Regulatory Advisors###Presenter: – Evera Regulatory Advisors
###
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 StrategyLocation: Concourse BPharma/Biologics
Linda F. Bowen, MSc, RAC-US, RAC-EU, RAC-CDN, Fellow (she/her/hers) – Pfizer ### 551690###Presenter###Chief of Staff###Pfizer###Presenter: – Pfizer
### she/her/hers
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 BPresenter: – RTI
Presenter: – RTI
Pharma/Biologics
Mark Levi, PhD – RTI ### 2129426###Presenter###Director of Regulatory Affairs###RTI###Presenter: – RTI
### @@@ Xi Yang, PhD, DABT (she/her/hers) – RTI ### 2129427###Presenter###Nonclinical Scientist###RTI###Presenter: – RTI
### she/her/hers
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 StrategyLocation: Concourse C/DPresenter: – Siemens Healthineers
Medical Device/IVD
Susumu Nozawa, RAC, FRAPS – Siemens Healthineers ### 1293270###Presenter###Head of Regulatory Policy - North America###Siemens Healthineers###Presenter: – Siemens Healthineers
###
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 SectionLocation: Concourse BPresenter: – Focused Consulting, Staffing, & Drug Safety, LLC
Pharma/Biologics
Michael E. Kieffer, Pharm.D. – Focused Consulting, Staffing, & Drug Safety, LLC ### 2199684###Presenter###Consultant (freelance)###Focused Consulting, Staffing, & Drug Safety, LLC###Presenter: – Focused Consulting, Staffing, & Drug Safety, LLC
###
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 AcceptanceLocation: Concourse C/DMedical Device/IVD
Marc Horner, PhD – Ansys ### 2129432###Presenter###Distinguished Engineer###Ansys###Presenter: – Ansys
###
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 FrameworksLocation: Concourse BPresenter: – Alexion, AstraZeneca Rare Disease
Pharma/Biologics
Jethro E. Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease ### 1945996###Presenter###Vice President, Regulatory Affairs###Alexion, AstraZeneca Rare Disease###Presenter: – Alexion, AstraZeneca Rare Disease
###
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 DevicesLocation: Concourse C/DMedical Device/IVD
Joshua D. Levin, AM, PhD, RAC (device) – ASELL LLC ### 2235913###Presenter###Director of Quality Assurance and Regulatory Affairs###ASELL LLC###Presenter: – ASELL LLC
###
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 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
###
