Labeling Creation: Impact on Adpromo and the Importance of Cross-Functional Collaboration

Tuesday, September 13, 2022

4:35 PM – 5:30 PM MST

Location/Room: W103 A-B

Learning Level Strategic

Session Leader/Speaker(s)

Micheline Awad, MBA

Sr. Director, Regulatory Affairs – Advertising, Promotion, and Labeling
Turning Point Therapeutics, Inc.

Speaker(s)

Lisa M. Kelsey, MA LMFT

Group Director, Head of Commercial Labeling
Genentech, Inc.

Slides

This session will explore the process for developing labeling that meets both regulatory and commercial needs. Presenters will discuss the importance of collaborating with cross-functional partners, specifically focusing on Labeling and Advertising and Promotion functions, to help shape the label and support product promotion. Case studies will be leveraged to discuss: 1) demo/training kits, samples, 2) business impact when labeling changes occur and aren’t communicated, and 3) need to include pivotal data, such as long-term extension or secondary endpoints, into your label vs applying current FDA guidelines (CFL guidance).

Learning Objectives:

Understand the importance of integrating Regulatory Labeling functions and AdPromo into label development by balancing label approval priority while meeting promotional needs
Use case studies to apply lessons learned at your organization
Learn best practices for collaboration and integrating Regulatory Labeling functions and AdPromo into Global Development Teams