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Trk 05: Reg of Prod Adv/Mkting [clear filter]
Tuesday, June 28
 

10:30am

#213: FDA Enforcement Update: Advertising and Promotion
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... 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 (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →
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... Read More →


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

2:00pm

#238: Prescription Drug Marketing Regulatory Primer
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will provide a basic introduction to the regulation of prescription drug advertising and promotion. It will cover such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.

Learning Objectives

Discuss important environmental forces and agencies impacting the regulation of prescription drug promotion; Apply advertising and promotional regulations to advertising/marketing materials; Explain the importance of reviewing FDA regulatory letters as they apply to these regulatory decisions.

Chair

Lucy Rose, MBA

Speaker

FDA Perspective
Thomas W. Abrams



Chair
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC

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 (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA