Become a member
Menu Back toSession 2: FDA Update

Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.

Session 2: FDA Update

Session Chair(s)

Wayne Pines

Wayne Pines

  • President, Health Care
  • APCO Worldwide Inc., 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

  • President, Health Care
  • APCO Worldwide Inc., United States
Elizabeth Pepinsky, JD

Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance

Elizabeth Pepinsky, JD

  • Health Science Policy Analyst
  • FDA, United States
Thomas W. Abrams, MBA, RPh

FDA Update on Oversight of Prescription Drug Promotion

Thomas W. Abrams, MBA, RPh

  • Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
  • Former FDA, United States
Lisa Stockbridge, PhD

CBER APLB

Lisa Stockbridge, PhD

  • Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
  • FDA, United States
Melissa Burns, MS

Introduction to Combination Products

Melissa Burns, MS

  • Senior Program Manager, Office of Combination Products, OCPP, OC
  • FDA, United States

Contact us

Registration Questions?

Send Email
1.888.257.6457

Preconference Primer

Drug and Medical Device Ad Promo Primer

On Demand Content Preview Webinar

Ad/Promo eCTD Submissions Round Table

Additional Information

Advertising and Promotion Regulatory Affairs Resource Kit

View Infographic