Prepare now for the new adverse event reporting law
Feb 22 educational tele-seminar from AHPA offers practical implementation info
(Silver Spring, MD) — The American Herbal Products Association (AHPA) will present an educational tele-seminar on February 22 to teach the dietary supplements industry how to take any reports of serious adverse events associated with their products. A new law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, signed into law just last month, goes into effect in December 2007. It requires that serious adverse event reports (AERs) be sent to the Food and Drug Administration (FDA) so that any public safety concerns can be identified and dealt with quickly.
AHPA has long supported the new AER law. Its presenters will take the mystery out of the required FDA forms and will help companies establish standard operating procedures to comply with the new law.
This practical course will cover the new legal obligations, FDA’s inspection authority, recordkeeping, staff preparation, and more. Speakers will address how to respond to calls from consumers and healthcare providers, and how to complete the MedWatch form with a special focus on how to take a medical history. Also, attendees will be able to distinguish between a quality issue complaint and an AER, as well as between a serious and non-serious adverse event.
AHPA’s tele-seminars are convenient and cost-effective, offering insight and enhancing knowledge important to your business. You will be provided with practical, useful documents to assist with AER compliance. Please note, the registration fee is charged per phone connection, but as many staff members as you wish may listen in on your speaker phone.
Event Date: Thursday, February 22, 2007 // Time: 1pmET – 3pmET
Where: Your telephone or office conference room
Cost: $195 per line for AHPA members / $495 per line for non-members (unlimited participants!)
Includes an unedited transcript
Includes a Certification of Completion (additional certificates, $25 each)
Optional Audio CD — $25
Registration: Register with this online form to fax or email back: http://www.ahpa.org/portals/0/pdfs/07_02_AHPA_AER.xls.
Advance registration only; the deadline is 24 hours prior to the event. Once registered, a confirmation email will be sent to you and all supporting resource documents and instructions will be sent via email.
Any questions? Please contact Devon Powell at firstname.lastname@example.org, or 301-588-1171, x102.
The American Herbal Products Association (AHPA) is a trade association representing the core of the botanical trade — comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s 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 herbs are manufactured, labeled, and sold. Website: www.ahpa.org.