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Session 7: Non-Traditional Data – Labeling versus Promotion
Session Chair(s)
Su-Yueh Lin
Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
Explore and discuss the use and placement of the non-traditional data (e.g., long term extension study data, open labeling study data, RWE, etc.) in labeling and promotion. Application of the “consistent with the FDA-required labeling” final guidance will be presented. A panel discussion will provide an interactive learning experience using case studies to help drive the conversation and determine the appropriate course of action.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the different types of non-traditional data and the possibility and pros/cons for inclusion in labeling or promotional materials
- Explain the current guidelines and practices of inclusion of the non-traditional data in promotional materials
- Evaluate and apply this knowledge in labeling strategy and content development
Speaker(s)
Micheline Awad, MBA
Day One Biopharmaceuticals, United States
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Speaker
Heather Hammond, MSC
Regeneron, United States
Associate Director, Reg Labeling