Serious Adverse Events are an important FDA requirement for over-the-counter (OTC) drugs and dietary supplement in the United States. Learn the background and history of SAE reporting regulations, the challenges of deciding what constitutes a SAE, when and how to report an Adverse Event as well as the differences between reporting requirements for OTC drugs and dietary supplements vs. requirements for cosmetics. 


Presented by CHPA/EAS Consulting Group, LLC

Moderated by Marcia D. Howard, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA

Webinar Objectives
  • Learn FDA definition of a serious adverse event and how it relates to a company's reporting obligations.
  • The role of the Healthcare professional in SAE reporting.
  • Is reporting a SAE admission that your product caused the event?
  • The Personal Care Products Safety Act and how this will change SAE reporting for Cosmetics.
  • Understand specific SAE reporting and recordkeeping requirements and information.
Seminar Information
Date Presented:
February 20, 2018 2:00 PM Eastern
1 hour
CHPA Member Price:
Non-Member Price:
Adverse Event Reporting - What You Need to Know
Speaker Information
Norma Skolnik  [ view bio ]
Individual topic purchase: Selected
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