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Tuesday, June 28 • 10:30am - 11:30am
#213: FDA Enforcement Update: Advertising and Promotion

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Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA enforcement actions and policy guidances need to be understood by every company because they reflect FDA's priorities and concerns in regulating advertising and promotion. In this forum, FDA representatives will examine the latest agency enforcement actions and policies and what they mean.

Learning Objectives

Describe the latest FDA enforcement actions and policy initiatives in the area of advertising and promotion; Explain what the enforcement actions reflect about FDA policies and priorities.

Chair

Philomena McArthur, JD

Speaker

CDER Perspective
Thomas W. Abrams

CBER Perspective
Lisa L. Stockbridge, PhD



Chair
avatar for Philomena McArthur

Philomena McArthur

Vice President Global Policies, Procedures & Training, Healthcare Compliance & P, Johnson & Johnson International
Philomena McArthur's diversified experience spans 25 yrs. She currently oversees the Regulatory Advertising & Promotion Dept. in Health Care Compliance supporting the Janssen Pharmaceutical companies of Johnson & Johnson, for whom she has worked for 10 yrs. Philomena has held a variety of roles at other companies including BMS and Pfizer, and has worked as a litigation attorney in New Jersey. She has a BA in biology from Bucknell Univ. & a JD cum... Read More →

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (OPDP), Food and Drug Administration. Before becoming Director of OPDP, Mr. Abrams was Director of the Division of Drug Marketing, Advertising, and Communications.
avatar for Lisa Stockbridge

Lisa Stockbridge

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA
Dr. Stockbridge is chief of the Advertising and Promotional Labeling Branch in CBER’s Office of Compliance and Biologics Quality. Her team reviews promotional labeling and advertising, proprietary names, and product labeling. With over 15 years of experience in both CDER’s DDMAC and CBER’s APLB, she continues to serve on taskforces and special projects. Dr. Stockbridge holds a B.A. in Biology and Psychology from Manhattanville College and a... Read More →


Tuesday June 28, 2016 10:30am - 11:30am
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA