The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.
The law goes into effect December 22, 2007. This Webinar will provide practical tips to comply with and implement the Adverse Event Reporting requirement with useful information regarding the minimum data elements to be submitted in such reports. The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor.
How to submit AE report to the FDA?
What are the Recordkeeping requirements?
Which MedWatch form to use?
How to answer a customer Adverse Event phone call/letter?
What information should be collected from the customer?
How to take the Adverse Event history?
The law goes into effect December 22, 2007. This Webinar will provide practical tips to comply with and implement the Adverse Event Reporting requirement with useful information regarding the minimum data elements to be submitted in such reports. The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor.
Areas Covered in the seminar:
What is a serious adverse event?How to submit AE report to the FDA?
What are the Recordkeeping requirements?
Which MedWatch form to use?
How to answer a customer Adverse Event phone call/letter?
What information should be collected from the customer?
How to take the Adverse Event history?
Who Will Benefit:
- Dietary Supplement Manufacturers
- Dietary Supplement Packers
- Dietary Supplement Distributors
- CEO’s and Presidents of such companies
- Regulatory Affairs personnel
Course Provider
Ashish Talati,
