05.01.07
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) now offers an educational program, “Adverse Event Reporting: How to Comply with the New Law,” which 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.
For further information: 301-588-1171.
For further information: 301-588-1171.