Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
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.
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.
All OTC drugs and Dietary Supplements are required to report Serious Adverse Events to FDA. When the Personal Care Products Safety Act becomes law, Cosmetics will also have to report Adverse Events to FDA. It’s essential that companies understand how to define and report a Serious Adverse event and what labeling and recordkeeping regulations are required under the Dietary Supplement & OTC Drug Consumer Protection Act.
Learning Objectives
- Background to FDA Serious Adverse Event reporting regulations
- Understand how to define a Serious Adverse Event
- Learn what products are covered and what changes are coming
- Understand specific SAE reporting and recordkeeping requirements and information
- Changes that are coming for Cosmetics with the Personal Care Products Safety Act
Who Should Attend
- Regulatory Affairs managers and associates at drug, Supplement, or Cosmetic firms
- Quality Assurance managers at drug, Supplement, or Cosmetic firms
- Consumer Affairs managers & representatives
- Marketing managers in Drug, Supplement, or Cosmetic industries
- Safety managers
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