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The Essentials of U.S. Drug Labeling and Advertising Laws

 
  June 10, 2013  
     
 
CfPA - The Center for Professional Advancement, East Brunswick, NJ
October 3-4, 2013


Who Should Attend
This course will be valuable to professionals in the Pharmaceutical and Biotechnology industries.

Job functions: Regulatory Affairs, Quality Control Managers, Auditors, Technicians and Legal

Departments: Legal, QA/QC, Regulatory, Manufacturing, Marketing, Packaging and Graphics.

Description
Drug Labeling and Advertising is a highly regulated activity, and it is critical for pharmaceutical companies to be familiar with all applicable federal laws and regulations. While FDA has primary authority in this area, other federal agencies, including the FTC, the PTO, the DEA, and the CBP, exercise limited authority.

This course will provide an explanation of Federal laws and regulations applicable to pharmaceutical labeling and advertising, as well as federal authority to investigate and take enforcement action against violative drug labeling and advertising. It will review FDA requirements relevant to all drug labeling and advertising, and those that are specific to over-the-counter drugs and prescription drugs. Label content and format requirements will be explained, along with the exemptions from and modifications to the full labeling requirements. In addition to the FDA requirements, there will be a thorough review of other agency requirements, including FTC advertising standards, and PTO and CBP marking requirements, among others. FDA’s drug product listing requirements will also be explained.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Ann Begley; Partner, Morgan, Lewis & Bockius LLP

Ann Begley, BSN, JD, is a partner with Morgan, Lewis & Bockius, LLP., and regularly counsels clients on Food and Drug Administration-related laws and regulations, including those impacting the formulation, labeling, and advertising of pharmaceutical drug products. Her experience extends to over-the-counter, prescription, and alternative drug product labeling and advertising, and includes considerable counseling and advocacy work related to Federal Trade Commission advertising laws and the Better Business Bureau’s National Advertising Division. Ms. Begley serves on the Editorial Advisory Board of Clinical Trials Advisor, and is a frequent speaker on FDA related issues. Prior to entering the field of law, Ms. Begley worked as a critical care nurse at Georgetown University Medical Center.

Ann Begley received her J.D. from Georgetown University School of Law (cum laude), and her undergraduate degree in Nursing from Georgetown University.

Rebecca L. Dandeker; Partner, Morgan, Lewis & Bockius, LLP

Rebecca L. Dandeker, JD, is a partner to the Washington D.C. office of Morgan, Lewis & Bockius, LLP. Her practice involves legal and regulatory counseling in the areas of pharmaceuticals, dietary supplements, cosmetics, and alternative therapies. Ms. Dandeker has a J.D. from Georgetown University Law Center and a B.S. from Liberty University. 
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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