Bloomingdale, IL (February 8, 2013)
NOW® Technical Director Michael Lelah, Ph.D., was an expert presenter in a webinar co-produced by all of the industry trade associations and two major publishers on Adverse Event Reporting (AER) held on February 5, 2013.
"Serious Adverse Event Reporting (sAER) for the Dietary Supplement Industry: Key Considerations from the Experts" was designed to raise awareness of, and provide training on, compliance with regulatory requirements for collecting, investigating, and reporting serious adverse events.
An Adverse Event (AE) is defined as "any health-related event associated with the use of a dietary supplement that is adverse." A dietary supplement AE is legally defined as a possible but not causal association with a product. In other words, an AER does not constitute proof that the supplement caused a problem; in many instances a medical investigation indicates that the issue was presumably caused by known side effects of medications or pre-existing medical conditions. But if potentially serious adverse events resulted, no matter what the probable cause, documentation, investigation, and prompt notification to the FDA is required. This webinar detailed these legal requirements.
Dr. Lelah described NOW's adverse event and serious adverse event reporting systems and how events are received, investigated, and reported. NOW has a robust system for adverse event reporting that is fully integrated into its quality management and regulatory compliance systems. This assures that anyone who experiences a medical event with a NOW product will receive full attention, from reporting to resolution.
More than 400 people attended the 90-minute webinar, which covered:
- FDA's response to AERs and what triggers agency action (Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA)
- Legal and regulatory requirements for dietary supplement businesses (Scott Bass, Partner, Sidley Austin LLP and Anthony Young, Partner, Kleinfeld, Kaplan & Becker LLP and AHPA General Counsel
- Preparations for receiving and recording an AER (Michael Lelah, Ph.D., Technical Director, NOW Foods)
- Taking an AER (Steve Swantek, President & CEO, PROSAR)
- Q & A
Illustrating the importance of this topic, the list of industry organizations co-sponsoring this event is notable: *
- American Herbal Products Association (AHPA)
- Consumer Healthcare Products Association (CHPA)
- Council for Responsible Nutrition (CRN)
- Natural Products Association (NPA)
- United Natural Products Alliance (UNPA)
In association with
- New Hope Natural Media