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Session 3: Best Practices for Implementing a Labeling Change
Session Chair(s)
Virginia Foley
Founder, CEO, Compliance Forward, United States
This session will discuss best practices for implementing different types of labeling changes. We will discuss planning strategies for label updates for currently marketed products and/or new product approval launches. Expect lively discourse about ways to implement and set timing for labeling changes. Discussion will include the impact to in-market materials, updating prescribing information, and important safety information. Emphasis will be put on being compliant whilst meeting the business needs.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize different labeling changes
- Discuss how to manage the timing and impact to in-market materials
- Identify the nuances and importance of strategic implementation of labeling for both line extensions and new product launches
Speaker(s)
Cynthia Collins, PhD
Executive Director, Regulatory Affairs, Gilead Sciences, United States
Best Practices for Implementing a Labeling Change
Jae Kim
Senior Associate, DLA Piper, United States
Speaker
Bryant Godfrey, JD, MHA
Partner, Co-Chair, FDA Practice , Foley Hoag, United States
Speaker