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Meet and Greet with OPDP Staff
Session Chair(s)
Catherine Gray, PHARMD
Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling, Day One Biopharmaceuticals, United States
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States
This session will feature eighteen OPDP staff members participating in a meet and greet opportunity with conference attendees. Reviewers or Team Leaders from the Metabolic & Endocrine, Anti-Infective, Cardiovascular, Medical Imaging, Ophthalmology, Renal, Transplant, Addiction, Analgesics, Anesthetics, Antivirals, Dental, Dermatology, Osteoporosis, Reproductive, Urology, Neurology/Psychiatry, and Oncology dockets will engage in an informal conversation about their experience in OPDP. OPDP’s Deputy Directors for the Division of Advertising and Promotion Review 1 and 2, the Acting OPDP Director and the Assistant to the Director will also engage in the conversation.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the reviewer or TL for a number of OPDP therapeutic dockets
- Identify the diversity of educational backgrounds and professional experiences among OPDP staff members
- Efficiently communicate with the reviewer or TL for a therapeutic docket
Speaker(s)
Joanne Hawana, JD, MS
Member, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Panelist
Twyla Thompson, PHARMD
Deputy Division Director, Division of Advertising and Promotion 2, OPDP, FDA, United States
Panelist
Meena Savani, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 2, FDA, United States
Panelist
Charuni Patel Shah, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 2, OPDP, CDER, FDA, United States
James Dvorsky, PHARMD
Team Leader, Division of Advertising and Promotion 2, FDA, United States
Panelist
Samuel Skariah, PHARMD
Team Leader, Division of Advertising and Promotion 1, CDER/DDMAC, FDA, United States
Panelist
Lisa Hubbard, PHARMD, RPH
Deputy Division Director, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Panelist
Matthew Falter, PHARMD, RPH
Deputy Division Director, DAPR2/OPDP, FDA, United States
Panelist
Dhara Shah, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 1, FDA, United States
Panelist
Sapna Shah, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Christine Bradshaw, PHARMD, RAC
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Panelist
Jean-Ah Kang, PHARMD
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER, FDA, United States
Panelist
Lynn Panholzer, PHARMD
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Panelist
Nazia Fatima, PHARMD, MBA
Associate Director Global Regulatory Affiars, Kite Pharma, United States
Panelist
Trung-Hieu Brian Tran, PHARMD, MBA
Team Leader, Division of Advertising and Promotion 1, OPDP, CDER, FDA, United States
Nima Ossareh, PHARMD, RAC
Senior Manager, Regulatory Affairs, Regeneron, United States
Susannah O'Donnell, MPH, RAC
Team Leader, Division of Advertising and Promotion Review 1, FDA, United States
Panelist
Catherine Gray, PHARMD
Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States
Panelist
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