As part of the series EAS is presenting on behalf of CHPA’s OTC Academy, Norma Skolnik will speak to Serious Adverse Events Reporting on February 20th at 2 pm ET. Serious Adverse Events are an important FDA requirement for over-the-counter (OTC) drugs and dietary supplements in the United States. In this webinar, participants will learn the background and history of SAE reporting regulations, the challenges of deciding what constitutes an 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.
On March 6th, Senior Director of Dietary Supplements, Tara Lin Couch, Ph.D. will present on Conducting a Scientifically Sound Out of Specification (OOS) Investigation. More information on both webinars can be found in the hyperlinks or by contacting the Consumer Healthcare Products Association.
Posted in EAS in Action.