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Virtual

Mar 08, 2021 9:45 AM - Mar 10, 2021 5:05 PM

(US Eastern Standard Time)

Advertising and Promotion Regulatory Affairs Conference

Meet and Greet with OPDP Staff

Session Chair(s)

Catherine  Gray, PharmD

Catherine Gray, PharmD

Director, Office of Prescription Drug Promotion, OMP, CDER

FDA, United States

Micheline  Awad, MBA

Micheline Awad, MBA

Sr. Director, Regulatory Advertising, Promotion, and Labeling

Day One Biopharmaceuticals, United States

Kimberly  Belsky, MS

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

Panelist

Joanne Hawana, JD, MS

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States

Member

Twyla  Thompson, PharmD

Panelist

Twyla Thompson, PharmD

FDA, United States

Deputy Division Director, Division of Advertising and Promotion 2, OPDP

Meena  Savani, PharmD

Panelist

Meena Savani, PharmD

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 2

Charuni Patel Shah, PharmD

Charuni Patel Shah, PharmD

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 2, OPDP, CDER

James  Dvorsky, PharmD

Panelist

James Dvorsky, PharmD

FDA, United States

Team Leader, Division of Advertising and Promotion 2

Samuel  Skariah, PharmD

Panelist

Samuel Skariah, PharmD

FDA, United States

Team Leader, Division of Advertising and Promotion 1, CDER/DDMAC

Lisa  Hubbard, PharmD, RPh

Panelist

Lisa Hubbard, PharmD, RPh

CDER, FDA, United States

Deputy Division Director, Division of Advertising and Promotion 1, OPDP

Matthew  Falter, PharmD, RPh

Panelist

Matthew Falter, PharmD, RPh

FDA, United States

Deputy Division Director, DAPR2/OPDP

Dhara  Shah, PharmD

Panelist

Dhara Shah, PharmD

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 1

Sapna  Shah, PharmD

Sapna Shah, PharmD

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER

Christine  Bradshaw, PharmD, RAC

Panelist

Christine Bradshaw, PharmD, RAC

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER

Jean-Ah  Kang, PharmD

Panelist

Jean-Ah Kang, PharmD

FDA, United States

Special Assistant to the Director, Office of Prescription Drug Promotion, CDER

Lynn  Panholzer, PharmD

Panelist

Lynn Panholzer, PharmD

FDA, United States

Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER

Nazia  Fatima, PharmD, MBA

Panelist

Nazia Fatima, PharmD, MBA

Sunovion, United States

Associate Director Global Regulatory Affiars

Trung-Hieu Brian Tran, PharmD, MBA

Trung-Hieu Brian Tran, PharmD, MBA

FDA, United States

Team Leader, Division of Advertising and Promotion 1, OPDP, CDER

Nima  Ossareh, PharmD, RAC

Nima Ossareh, PharmD, RAC

Regeneron, United States

Senior Manager, Regulatory Affairs

Susannah  O'Donnell, MPH, RAC

Panelist

Susannah O'Donnell, MPH, RAC

FDA, United States

Team Leader, Division of Advertising and Promotion Review 1

Catherine  Gray, PharmD

Panelist

Catherine Gray, PharmD

FDA, United States

Director, Office of Prescription Drug Promotion, OMP, CDER

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