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:
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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:
  • Regulatory requirements for adverse event reporting for DS and OTC products
  • Best practices for collection and documentation of adverse events for such products
  • How, when and where to submit reports
  • Electronic submission of reports
  • Similarities and differences in reporting adverse events for DS and OTC products
  • Trends in FDA audit for DS and OTC reporting
  • Best practices for monitoring, apps, social media and web-sites for adverse event information
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Dietary supplement and OTC manufacturers, marketers,
  • Regulatory Compliance Associates and Managers
  • Legal and medical experts involved in DS ad OTC industry
  • People investing in FDA-regulated product development projects
Date: December 14, 2018
Time: 12 PM ET        
​Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com