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

Instructor: Norma Skolnik
Product ID: 704371
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.

Why Should You Attend:

This webinar will cover requirements for all manufacturers, packers, or distributors whose name appears on a drug or dietary supplement product label for adverse event reporting. The program will also include discussions on FDA notification requirements, determination of what constitutes a serious adverse event, procedures for filing reports, and record keeping requirements.

Areas Covered in the Webinar:

  • Understand adverse event reporting requirements for OTC drugs and dietary supplements
  • Understand how a serious adverse event is determined
  • Learn correct procedures for filing FDA notifications
  • Be able to implement FDA recordkeeping requirements

Who Will Benefit:

  • Regulatory affairs managers
  • Directors and associates
  • Compliance specialists
  • Marketing managers
  • QA managers

Instructor Profile:

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 as associate director of marketed product support for Lederle Laboratories and associate director of regulatory affairs for Wyeth. She currently works as a regulatory consultant.

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