(April 3, 2007, Silver Spring, MD) — When the Dietary Supplement and Nonprescription Drug Consumer Protection Act goes into effect in December 2007, dietary supplement and OTC drug companies will be required to submit serious adverse event reports (AERs) to the FDA so that any public safety concerns can be identified and dealt with quickly. To help companies train staff and put policies in place as they prepare to comply with the new law, the American Herbal Products Association (AHPA) offers an educational program, Adverse Event Reporting: How to Comply with the New Law, that explains the law, educates companies on how to take any reports of serious adverse events associated with products, and assists companies with developing their own AER system. Expert speakers clearly define a serious adverse event, and enable companies to handle an adverse event call properly — in particular focusing on how to complete FDA’s mandatory MedWatch form by asking callers the right questions in the right way.
Preparing to comply with the new federal requirements to report serious adverse events to FDA is not a difficult task — not when AHPA provides the expertise and tools you need. Based on practical, "step-by-step" advice and useful documents from a panel of legal, business and medical experts who know every detail of taking AERs, you can develop a formal and pragmatic adverse event reporting system. Further, companies will be able to distinguish between a quality issue complaint and an AER, and between a serious and non-serious adverse event.
What you'll learn from these experts to help you develop your company’s AER system efficiently and economically:
-- Tony Young, Esq. — general counsel to the American Herbal Products Association and the Pharmaceutical Distributors Association, partner with the law firm Kleinfeld, Kaplan and Becker, LLP. He has practiced food, drug and environmental law since 1974, representing ingredient and product manufacturers, developers and distributors. In 2004, Mr. Young testified about mandatory AER reporting before a U.S. Senate subcommittee, focusing on the scenario that the new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, will put into place when it goes into effect in December 2007. In this course, he explains companies’ legal obligations, including the practicalities of submitting AERs, recordkeeping requirements, and more.
-- Michael McGuffin — president of AHPA, Mr. McGuffin led the supplement industry toward recognizing the need for mandatory AERs, and was deeply involved in ensuring that the new law provide the same protections that the pharmaceutical and medical device industries have had in their respective AER systems. Active in the supplement industry since 1975, having owned both retail and manufacturing businesses, he has been AHPA’s president since 1999. He reviews the MedWatch forms, explains how to handle customer AER calls, and offers a step-by-step guide to creating a complete record.
-- Paula Gardiner, MD, MPH — research fellow at the Division for Research and Education in complementary and Integrative medical therapies at Harvard Medical School's Osher Institute, Dr. Gardiner's work focuses on dietary supplement safety issues, including interactions with prescription medicines. She is also a member of the U.S. Pharmacopeia's Dietary Supplements Expert Committee, where she has worked to improve adverse event reporting. In this course, she focuses on how to gather important medical details, including medical history, concurrent use of other medical products, and other relevant information.
Course materials cost $220 for AHPA members, $520 for non-members, and include:
-- "AER vs. Customer Complaint" — a decision-making flow chart
-- AHPA's AER MedWatch Worksheet — AHPA’s instructive form for recording information concerning an adverse event associated with dietary supplement product use
-- Presentations from all speakers
-- Written transcript, including answers to questions posed by attendees
-- Course Outline & Speakers Bios
-- Audio CD
Order the course materials online from AHPA's bookstore, and start your training program today: http://www.ahpa.org/Default.aspx?tabid=68#AERLAW
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.