New Benefit to allow Association Members to Manage Adverse Event Reports and Report Serious Incidents to the FDA
November 7, 2007 (Washington, D.C) – The Natural Products Association is partnering with SafetyCall®, one of the most experienced adverse event reporting (AER) call centers in the country, to offer reduced rates for services to association members to help them prepare for changes in reporting requirements after implementation of new laws affecting AERs for dietary supplements. In addition to this added benefit, the Natural Products Association and SafetyCall® will also hold a series of education events throughout the year to help companies adjust to the new regulation and to ease the transition.
According to Daniel Fabricant, Ph,D., vice president of scientific and regulatory affairs at the association, “the recently offered guidance stressed the importance of using trained healthcare practitioners in meeting the regulatory requirements. Through our partnership with SafetyCall® and continued educational opportunities for members, the Natural Products Association hopes to ensure that our members easily adjust and continue to grow and prosper,” Fabricant said.
SafetyCall® experts have more than 25 years experience in fielding AE calls for the consumer product industry and are one of the few organizations with academic, professional and safety expertise specifically related to dietary supplements. SafetyCall’s medical professionals are also well known for their ability to add medical context to spontaneously reported incidents in order to put alleged events in proper context and recognize the inherent safety of marketed dietary supplements. The company will provide assistance for turnkey regulatory reporting to the U.S. Food and Drug Administration (FDA) once the AER law is implemented, on December 22 of this year. The partnership will immediately take effect. Services now available to Natural Products Association members include 24-hour call center support, management of adverse event incidents, and documentation systems that meet archive requirements and produce ready for submission 15-day reports for FDA.
“We’re happy to partner with the Natural Products Association and work with their members at a time when there’s a rush to conform to the new reporting requirements,” said Richard Kingston, Pharm,D., president, regulatory and scientific affairs, at SafetyCall®. “We’re confident that we can meet the increased demand and quickly respond to and document adverse event reports on behalf of participating association member companies,” Kingston said.
For more information on the association’s new partnership with SafetyCall® or any upcoming educational events dealing with the transition to new AER regulations, contact Daniel Fabricant at (202) 223-0101 ext. 102 or e-mail [email protected].
About The Natural Products Association
The Natural Products Association (www.NaturalProductsAssoc.org) is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. The association represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.