Norma Skolnik
Instructor Norma Skolnik
Product Id 600494
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Dietary Supplements and OTC Drugs - Adverse Event Reporting


Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs.

Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to answer.

Why Should You Attend: There are often questions about what FDA considers to be an adverse event and about Adverse event reporting requirements for Dietary Supplements and OTC drugs. This Webinar will help to answer those questions and will help assure manufacturers and importers that they comply with the law.

Areas Covered in the Session:

  • Adverse event reporting and recordkeeping requirements of the Dietary Supplement &Nonprescription Drug Consumer Protection Act
  • Questions & Answers regarding the Labeling of Dietary Supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Who Will Benefit: Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar:
  • Regulatory Professionals
  • Drug Marketers
  • Manufacturers and Distributors
  • Students of FDA Regulations

Speaker Profile
Norma Skolnik has 30 years of regulatory experience in the OTC Drug, Food and Dietary Supplement industries. She has had extensive experience advising on regulatory strategies for new and marketed consumer healthcare products. Particularly regarding the development and review of optimal product claims and advertising. For 10 years, Norma served as Director of Regulatory Affairs for Cadbury Adams, Americas (formerly Adams Division of Pfizer). Previously she was Associate Director of Regulatory Affairs at Wyeth Consumer Healthcare and Associate Director, Regulatory Affairs at Lederle Consumer Health division of American Cyanamid.

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