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Welcome to Day 2 and Session 5: Strategies for Development Labeling
Session Chair(s)
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
Hayley Parker, PHD, MSC
Senior Vice President, Pepgen Inc., 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)
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
Moderators
Hayley Parker, PHD, MSC
Senior Vice President, Pepgen Inc., United States
Moderators
Vijay Sammeta, DrMed, MBA
Senior Director, GRA Labeling, Sanofi, United States
Panelists
Parul Shukla, RPH
Associate Director, Global Labeling, Bayer U.S., United States
Suzanna Leacy
Director, Global Labeling Development, GSK, United Kingdom
Speaker
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