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Welcome to Day 2 and Session 5: Strategies for Development Labeling
Session Chair(s)
Gerrit Nijveldt, MSc
Global Labeling Consultant
Opus Regulatory Inc., United States
Hayley Parker, PhD, MSc
Vice President Regulatory Affairs
PepGen, United States
This session will discuss labeling throughout drug development from a global and local (e.g., US, EU, Japan) perspective. This session will include a discussion on when to start the process, the needed resources for global submissions, effective strategies and how to negotiate with your company to include labeling department in discussions. This session will include examples from different companies and case studies followed by a Q&A.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the value of labeling during drug development from a global and local perspective
- Restate its value for a company, including the labeling department
- Identify a strategy for creating labeling and advocate for the needed resources for success
Speaker(s)
Moderators
Gerrit Nijveldt, MSc
Opus Regulatory Inc., United States
Global Labeling Consultant
Moderators
Hayley Parker, PhD, MSc
PepGen, United States
Vice President Regulatory Affairs
Panelists
Vijay Sammeta, DrMed, MBA
Sanofi, United States
Senior Director, GRA Labeling
Parul Shukla, RPh
Bayer U.S., United States
Associate Director, Global Labeling
Speaker
Suzanna Leacy
GSK, United Kingdom
Director, Global Labeling Development
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