戻る Agenda
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)
Panelist
Joanne Hawana, JD, MS
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
Member
Panelist
Twyla Thompson, PharmD
FDA, United States
Deputy Division Director, Division of Advertising and Promotion 2, OPDP
Panelist
Meena Savani, PharmD
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 2
Charuni Patel Shah, PharmD
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 2, OPDP, CDER
Panelist
James Dvorsky, PharmD
FDA, United States
Team Leader, Division of Advertising and Promotion 2
Panelist
Samuel Skariah, PharmD
FDA, United States
Team Leader, Division of Advertising and Promotion 1, CDER/DDMAC
Panelist
Lisa Hubbard, PharmD, RPh
CDER, FDA, United States
Deputy Division Director, Division of Advertising and Promotion 1, OPDP
Panelist
Matthew Falter, PharmD, RPh
FDA, United States
Deputy Division Director, DAPR2/OPDP
Panelist
Dhara Shah, PharmD
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 1
Sapna Shah, PharmD
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
Panelist
Christine Bradshaw, PharmD, RAC
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
Panelist
Jean-Ah Kang, PharmD
FDA, United States
Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
Panelist
Lynn Panholzer, PharmD
FDA, United States
Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
Panelist
Nazia Fatima, PharmD, MBA
Sunovion, United States
Associate Director Global Regulatory Affiars
Trung-Hieu Brian Tran, PharmD, MBA
FDA, United States
Team Leader, Division of Advertising and Promotion 1, OPDP, CDER
Nima Ossareh, PharmD, RAC
Regeneron, United States
Senior Manager, Regulatory Affairs
Panelist
Susannah O'Donnell, MPH, RAC
FDA, United States
Team Leader, Division of Advertising and Promotion Review 1
Panelist
Catherine Gray, PharmD
FDA, United States
Director, Office of Prescription Drug Promotion, OMP, CDER