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The Nuts and Bolts of U.S. Drug Labeling Requirements

 
  August 30, 2011  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
October 12, 2011 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend
This course is intended for professionals in the Pharmaceutical, Biotechnology and related industries.

It will be especially valuable for those active in: Legal, QA/QC, Regulatory and Manufacturing areas of these industries and will benefit those working in such functions as: Regulatory Affairs and Quality Control Managers, Auditors, and Technicians.

Description
This 90-minute, accredited training will provide an explanation of the Food and Drug Administration and other agency laws and regulations applicable to pharmaceutical labeling. It will review general principles relevant to all drug labeling, and those that are specific to over-the-counter drugs and prescription drugs. Both content and format requirements will be explained. The exemptions from and modifications to the full labeling requirements will be discussed, including those applicable to drug samples, small drug packages, and drug product intended for further packaging. Finally, the course will describe the FDA drug product listing requirements, and provide details on the steps necessary to submit the required product labeling and listing document electronically. This training will include opportunities for learning assessment.

Review of Learning Objectives
Module 1: General Overview of Statutes and Regulations Applicable to Drug Labeling

  • Statutes: FFDCA and other Federal Laws
  • FDA Regulations: General Drug Labeling Regulations; 
    OTC/Prescription Labeling; Drug Labeling Exemptions; 
    Drug Listing Requirements; CGMP Labeling and Labeling 
    Control Requirements
  • Other Agency Regulations Affecting Drug Labeling: Country
    of Origin; Child Resistant Packaging Requirements; FTC 
    Green Guides

Module 2: Labeling of OTC and Prescription Drugs
  • OTC Drug Labeling: General Labeling Requirements; Drug 
    Facts Requirements; OTC Monograph Labeling; New 
    Drug Labeling;
    Other
    – Combination Drug/Cosmetic (e.g., sunscreen products)
    – Homeopathic Drugs
  • Prescription Drug Labeling: General Label Requirements; 
    Package Insert Requirements; Medication Guide
    Requirements

Module 3: Overview of Electronic Drug Product Listing/Labeling Process
  • 3 Types of Structured Product Labeling (SPL) Submissions
  • Electronic Submission Requirements
  • Submission Process Overview
  • FDA SPL Resources

Question and Answer Session

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Ann Begley, BSN, JD, Partner with K&L Gates, LLP.

Ann Begley, BSN, JD, is a partner with K&L Gates, 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.

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

Ben McGinty, Senior Director, Business Development, Reed Technology

Mr. Ben McGinty has managed Life Sciences business development initiatives at Reed Technology since 2005. Previously he served as Reed Tech’s Director of Production Operations for data conversion, capture and delivery of U.S. Patent Applications for the U.S. Patent and Trademark Office. Mr. McGinty has over 35 years of experience in production operations and business management. Prior to his 13 years at Reed Tech, he managed various production and business administration activities at Lockheed Martin’s Management and Data Systems Division in Valley Forge, PA supporting US Federal Government defense contracts.

Mr. McGinty holds a Bachelor of Science in Business Administration from St. Joseph’s University, Philadelphia, PA and a Masters in Management from Rosemont College, Rosemont, PA.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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