New England Research Institutes Executive to Discuss Best Practices for Risk Mitigation Using Registries at 45th Annual Drug Information Association Meeting
Published: Jun 23, 2009
WATERTOWN, Mass.--(BUSINESS WIRE)--Flora Sandra Siami, Director, Regulatory Affairs, at New England Research Institutes, Inc. (NERI), has been selected to present best practices for risk mitigation using registries at the 45th Annual Meeting of the Drug Information Association (DIA). She will share lessons learned from NERI about risk mitigation through the practical application of registries. These insights will be discussed within the context of regulatory changes resulting from the Food and Drug Administration Amendments Act (FDAAA) of 2007 that empower FDA to impose risk evaluation and mitigation strategies (REMS). The conference will be held from June 21 – 25 in San Diego, California. NERI is a clinical research organization and a recognized leader in creating, analyzing, and merging complex datasets that comprise patient registries.