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Session 8: OPDP Meet and Greet
Session Chair(s)
Fadwa Almanakly, PHARMD
Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas, Bayer Pharmaceuticals, United States
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling, Day One Biopharmaceuticals, United States
This session will feature FDA staff members from the Office of Prescription Drug Promotion (OPDP), the Advertising and Promotional Labeling Branch (APLB), and the Regulatory Policy & Guidance Staff in the Office of Product Evaluation and Quality participating in a meet and greet opportunity with conference attendees. Staff members include reviewers, members of leadership, policy analysts and regulatory counsel.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the reviewer or TL for a number of OPDP, APLB or CDRH therapeutic dockets
- Identify the diversity of educational backgrounds and professional experiences among FDA staff members
- Efficiently communicate with the reviewer or TL for a therapeutic docket
Speaker(s)
Speaker
Deputy Division Director, DAPR2/OPDP, FDA, United States
Moderator
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Speaker
Team Leader, Division of Advertising and Promotion Review 1, FDA, United States
Speaker
Associate Director Global Regulatory Affiars, Kite Pharma, United States
Speaker
Division Director, Division of Promotion Policy, Research, and Operations, OPDP, FDA, United States
Speaker
, United States
Speaker
Regulatory Review Officer, Division of Advertising and Promotion 1, FDA, United States
Speaker
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States
Speaker
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA, United States
Speaker
Program Coordinator, FDA, United States
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