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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)
Matthew Falter, PHARMD, RPH
Deputy Division Director, DAPR2/OPDP, FDA, United States
Speaker
Sapna Shah, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Moderator
Susannah O'Donnell, MPH, RAC
Team Leader, Division of Advertising and Promotion Review 1, FDA, United States
Speaker
Nazia Fatima, PHARMD, MBA
Associate Director Global Regulatory Affiars, Kite Pharma, United States
Speaker
Kathleen David, BSN
Division Director, Division of Promotion Policy, Research, and Operations, OPDP, FDA, United States
Speaker
Amy Muhlberg, PHD
, United States
Speaker
Jennifer Chen, PHARMD, MBA, RPH
Regulatory Review Officer, Division of Advertising and Promotion 1, FDA, United States
Speaker
Deborah Wolf, JD
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States
Speaker
Lisa Stockbridge, PHD
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA, United States
Speaker
Oluchi Elekwachi, PHARMD, MPH
Program Coordinator, FDA, United States
Speaker
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