adverse-event-reporting-rules-for-otc-drugs-dietary-supplements-cosmetics

Adverse Event Reporting Rules for OTC Drugs, Dietary Supplements & Cosmetics

Live Webinar

  • 60 minutes
  • 10 Days Left
     Apr 30, 2019
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

In order to market dietary supplements and OTC drugs in the U.S.A., reporting serious adverse events is mandatory. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid refusal of product entry into the U.S. or an FDA warning letter or FDA audit issues. Serious Adverse Event reporting will also soon be required for all Cosmetics and it’s essential that Cosmetic companies learn what will be required of them.

Join this session by expert speaker Norma Skolnik, where she will provides an overview of FDA OTC Drug regulations with a focus on OTC Drug. It will help the attendee understand basic regulatory requirements for marketing and labeling OTC drugs successfully in the U.S.A

Session Highlights:

  • Understand FDA Adverse Event (AE) labeling requirements

  • Review current AE mandatory reporting requirements for OTC drugs and Dietary Supplements

  • Cover coming AE requirements for all Cosmetics

  • Understand how a Serious Adverse Event is determined

  • Learn correct procedures for filing FDA AE notifications

  • Be able to implement FDA recordkeeping requirements

Why You Should Attend:

This webinar will cover Adverse Event requirements for all manufacturers, packers, or distributors of OTC drug or dietary supplement products for mandatory serious adverse event reporting. Included will be important FDA labeling and AE notification requirements, determination of what constitutes a serious adverse event, procedures for filing reports and all FDA record keeping requirements. Important future requirements for reporting Cosmetic Adverse Events will also be covered.

Who Should Attend:

  • Consumer Healthcare firms

  • OTC Drug companies

  • Dietary Supplement Manufacturers & Distributors

  • Cosmetic manufacturers & distributors


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Norma Skolnik

Norma Skolnik

Norma Skolnik is currently a Regulatory Consultant with over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She was Director of Regulatory Affairs for the Americas for Cadbury Adams and Director of Regulatory Affairs for the Adams division of Pfizer before that. Prior to that she was Associate Director of Regulatory Affairs for the Warner-Lambert company and Associate Director Regulatory Affairs at American Home Products Whitehall-Robbins Division.

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