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