Webinars >>OTC Drugs
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Dietary supplement and non-prescription product manufacturers are required to collect and report any adverse events associated with their products and report to the FDA within a defined time period. Despite the law stating that being in effect since early 2007, there is significant misunderstanding in the dietary supplement and over-the-counter (OTC) product industry regarding how to proactively collect information regarding adverse events, the ways to report, where to report and the time-periods allowed by the law.
Why should you attend:
This seminar will discuss the legal requirements and practical aspects of adverse event reporting for dietary supplement and OTC products. Key strategic considerations will be discussed using real-life case studies. Also discussed will be FDA forms, reports and other interactions critical for the industry. Impact of web-based, smart phone apps and social media tools for tracking adverse events, proactively addressing events and troubleshooting crisis events.
Areas Covered in the Session:
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: firstname.lastname@example.org