SafetyCall International unveils new system for the evaluation of Adverse Events in the Dietary Supplement Industry!

Dr. Rick Kingston , President of Regulatory and Scientific Affairs, SafetyCall International unveiled his newly designed “scoring system” for the evaluation of “serious” and “non-serious” adverse events in the Dietary Supplement and Nonprescription Drug area. Since the enforcement of the 2006 Dietary supplement and Nonprescription Drug Consumer Protection ACT in December 2007 . The FDA has published guidance documents regarding compliance and reporting of “serious” and “non-serious” reported events being evaluated by the FDA or others so as to insure that products are meeting expectations of safety, warranting consumer and regulator confidence. Experience to date demonstrates a high variability in quality and integrity of documented incidents and there is no recognized method regarding scoring of events by experts or FDA so as to assess potential associations between alleged adverse events and product use. Do these reported events signal safety issues? How can manfacturerers review their own experience, present their findings to customer, regulators and the media? Dr. Kingston unveils his new system to address these issues and teaches companies how to demonstrate a positive track record of product safety.