Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Date: May 2, 2025
Duration: 60 Minutes
Time: 12 PM EST
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:
- 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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
