U.S. Adverse Event Reporting Regulations for OTC Drugs, Dietary Supplements & Cosmetics

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

Get an Overview of FDA Requirements for Reporting Serious Adverse Events and Much More

Join expert speaker Norma Skolnik in this power-packed event which will offer an overview of FDA requirements for reporting serious adverse events for OTC Drugs, Dietary Supplements and Cosmetics in the U.S. Challenges of deciding what constitutes a serious adverse event, the when and how to report an Adverse Event will be covered, as will the differences between reporting requirements for OTC drugs and dietary supplements vs. requirements for cosmetics. You will also get the background and history of adverse event reporting regulation and would be acquainted with the FDA requirements of serious adverse event reporting.

At the end of the session, you will take away various references relevant to all FDA regulations. You will also receive guidance documents and FDA websites for Serious Adverse Event reporting as well as regulatory know-how tips.

Training Objective:

  • Background & history of adverse event reporting regulations
  • FDA requirements for serious adverse event reporting
  • How requirements for OTC drugs & dietary supplements differ from those for cosmetics?
  • What constitutes a serious adverse event?
  • How to complete and submit FDA medwatch forms?
  • Role of the healthcare professional

Who Should Attend

Regulatory Affairs managers, directors & associates, Product Safety managers, Compliance Specialists and anyone involved in product safety or planning to market or label OTC drugs, Dietary Supplements & Cosmetics in the U.S.



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About Our Speaker

Norma Skolnik - FDA Regulations Expert

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...   More Info
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