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Session 3: Best Practices for Implementing a Labeling Change
Session Chair(s)
Virginia Foley
VP Regulatory Lead, Life Sciences & Healthcare
Constellation, 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)
Best Practices for Implementing a Labeling Change
Cynthia Collins, PhD
Gilead Sciences, United States
Executive Director, Regulatory Affairs
Speaker
Jae Kim
DLA Piper, United States
Senior Associate
Speaker
Bryant Godfrey, JD, MHA
Foley Hoag, United States
Partner, Co-Chair, FDA Practice
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