This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
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.
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
Course Provider
Mukesh Kumar,
