Emergint receives contract to maintain FDA/CFSAN adverse event reporting system
(ROCKVILLE, MD) - The U.S. Food and Drug Administration (FDA) is the federal agency responsible for ensuring that foods, cosmetics, drugs, biologics, medical devices, and radiological products are safe. The Center for Food Safety and Applied Nutrition (CFSAN) is one of the FDA Centers. CFSAN's mission is to protect the public health by ensuring that the nation's food supply is safe, sanitary, wholesome, and properly labeled, and that cosmetic products are safe, sanitary, and properly labeled. CFSAN-regulated products include dairy products, plant foods, beverages, seafood, dietary supplements, cosmetic products, infant formula, medical foods, and food and color additives, and all ingredients that come into contact with foods. Emergint recently received a contract to provide IT support for the CFSAN Adverse Events Reporting System (CAERS).
In 2003, CAERS was created to help CFSAN conduct post-market surveillance activities. These activities include collecting, monitoring and analyzing Individual Case Safety Reports (ICSRs). These ICSRs consist of adverse events and product complaints alleging illnesses or injuries caused by CFSAN-regulated products. Examples include developing an eye infection after using mascara, or experiencing shortness of breath after taking a dietary supplement. Some ICSRs are submitted voluntarily by consumers, and health professionals; however, dietary supplement manufacturers, packers or distributors are required to submit reports for serious adverse events.
The Emergint team will perform IT support tasks for the CAERS project which includes project management, software upgrades, helpdesk support, user training, Oracle TMS and Business Objects support, in addition to limited development, modernization, and enhancement projects. Emergint's goal is to support the technology staff in ensuring that system stability, availability, security and data integrity are maintained which gives CFSAN effective tools to assist with carrying out its mission.
About Emergint
Emergint is committed to providing consultation and IT services to meet the evolving management and IT demands of our clients. Through these services, Emergint enhances the client's ability to achieve their strategic mission through measurable results.
Contact:
Ms. Connie Zhong
Director, Federal Healthcare Solutions, Capital Region
(866) 681-0149 ext 6118
connie.zhong@emergint.com