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DoubleTree by Hilton Washington DC - Crystal City

Feb 23, 2023 7:00 AM - Feb 24, 2023 4:15 PM

300 Army Navy Drive, Arlington, VA 22202

Advertising and Promotion Regulatory Affairs Conference

DIA’s Advertising and Promotion Regulatory Affairs Conference explores the current state of compliance for marketing both biopharmaceuticals and medical devices.

Session 3: Best Practices for Implementing a Labeling Change

Session Chair(s)

Virginia  Foley

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


Cynthia  Collins, PhD

Best Practices for Implementing a Labeling Change

Cynthia Collins, PhD

Gilead Sciences, United States

Executive Director, Regulatory Affairs

Jae  Kim


Jae Kim

DLA Piper, United States

Senior Associate

Bryant  Godfrey, JD, MHA


Bryant Godfrey, JD, MHA

Foley Hoag, United States

Partner, Co-Chair, FDA Practice

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