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Virtual Event

May 18, 2020 10:00 AM - May 20, 2020 3:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Advertising and Promotion Regulatory Affairs Conference

Session 2: FDA Update

Session Chair(s)

Wayne  Pines

Wayne Pines

President, Health Care

United States

This session, organized by senior representatives from the three FDA medical centers, will provide a summary of recent enforcement and actions taken in the ad promo area. This session will also present a perspective on the enforcement priorities and concerns of the FDA centers, recent guidance issued, and the guidance’s being developed.

Learning Objective :

At the conclusion of this session, the participant should be able to:

  • Understand better the recent ad promo enforcement actions, what motivated the agency to take enforcement action on that particular alleged violation
  • How the agency is viewing enforcement
  • What issues arise from the latest guidances and general policy evolution

Speaker(s)

Wayne  Pines

FDA Update

Wayne Pines

United States

President, Health Care

Elizabeth  Pepinsky, JD

Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance

Elizabeth Pepinsky, JD

FDA, United States

Health Science Policy Analyst

Thomas W. Abrams, MBA, RPh

FDA Update on Oversight of Prescription Drug Promotion

Thomas W. Abrams, MBA, RPh

Former FDA, United States

Retired, Director, Office of Prescription Drug Promotion, OMP, CDER

Lisa  Stockbridge, PhD

CBER APLB

Lisa Stockbridge, PhD

FDA, United States

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER

Melissa  Burns, MS

Introduction to Combination Products

Melissa Burns, MS

FDA, United States

Senior Program Manager, Office of Combination Products, OCPP, OC

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