The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor.
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
Instructor Profile:
Ashish Talati,
is Partner at Amin Hallihan, LLC. whose key practice areas include Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Customs, U.S. Drug Enforcement Agency (DEA), U.S. Department of Agriculture (USDA) and related Federal and State regulatory compliance and litigation matters, advertising law, intellectual property including patents, trademarks, copyrights, trade secrets and licensing, contracts, and business litigation. Ashish R. Talati primarily counsels companies and trade associations in the pharmaceutical and biotechnology industry on a wide range of issues surrounding U.S. Food and Drug Administration’s (FDA) review, approval, and oversight of drug and biological products.
