||cGMP Compliance Series: Adverse Event Reporting: Strategies for Compliance
October 16, 2007
AHPA presents strategic regulatory, medical and legal perspectives to help companies comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect December 2007 and requires dietary supplement manufacturers to file serious adverse event reports (AERs) with the Food and Drug Administration. In addition to reviewing the regulation and FDA’s guidance document, AHPA provides practical documents and insights from these expert speakers:
- Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel — reviews your legal obligations under the new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. In addition to reviewing FDA’s guidance document, he will also describe how the law differentiates a serious AER from an AER and a customer complaint and explain required reports and recordkeeping requirements.
- Michael McGuffin,AHPA’s President — focuses on how companies should communicate with their customers and how to use the current MedWatch form. He will also discuss the information needed to create a complete record of each report and add his insights into the FDA guidance.
- Tieraona Low Dog, MD, Director of Education for the Program in Integrative Medicine at the University of Arizona, Clinical Assistant Professor in the Department of Medicine and a Clinical Lecturer for the University of Arizona College of Pharmacy —explains important considerations when recording adverse event history, including how to focus on the clinical course of the reported event, medical history, recording concomitant use of other medical products and other relevant medical information.
Questions they answer include:
- How do we communicate AER information to our contracted manufacturer? Who should take those calls? Who should follow up afterwards?
- Can we handle this task in-house, or do we need to contract someone?
- Which MedWatch form should we use? None of them are really for dietary supplement or OTC products.
- We don’t have doctors on staff, so how (and who) decides if an AER is serious?
- How much should we follow-up after an adverse event is reported?
- Do we have to show our AER files to FDA during inspections?
- How can we get accurate information, and how much of their medical history is important?
- What should we tell our health food store and practitioner clients?
Support documents to help your company comply with the law include:
- “AER vs. Customer Complaint” — a decision-making flow chart
- Mandatory MedWatch form and facsimile MedWatch form
- “Quick Glance Advice about Mandatory Reporting”
- AHPA’s instructive form for recording information concerning an adverse event associated with dietary supplement product use
Member Price: $220.00
Non-Member Price: $520.00
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