Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

Why Should You Attend:

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.

This webinar 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.

This webinar will also review 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 Webinar:

• Regulatory requirements for adverse event reporting for dietary supplements 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 dietary supplements and OTC products
• Trends in FDA audit for dietary supplements and OTC reporting
• Best practices for monitoring, apps, social media and websites for adverse event information

Who Will Benefit:

• 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 dietary supplements and OTC industry
• People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.

Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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