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
February 20, 2018 2:00 PM Eastern
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