Elizabeth Andrews Appointed to Innovation in Medical Evidence Development, Surveillance Steering Committee

The committee will work to improve development, evaluation of methods for drug safety surveillance using healthcare data

RESEARCH TRIANGLE PARK, N.C. – Elizabeth Andrews, Ph.D., vice president, pharmacoepidemiology and risk management in RTI Health Solutions, a business unit of RTI International, has been appointed to serve as the academia/research institute representative on the Reagan-Udall Foundation, Innovation in Medical Evidence Development and Surveillance (IMEDS) steering committee.

IMEDS is a public-private partnership within the Reagan-Udall Foundation created to advance the science and tools necessary to support post-market evidence generation on regulated pharmaceutical products and medical device products, including safety surveillance and evaluations. The IMEDS project focuses on the use of a robust platform of existing and emerging electronic healthcare data to generate evidence in the post-marketing setting.   

The newly formed steering committee is comprised of top leaders in healthcare and scientific communities, with representation from diverse stakeholder groups. The steering committee will play a critical role in governing the program’s research and operations.

In 2007, Congress created the Reagan-Udall Foundation for the Food and Drug Administration to advance regulatory science and research for the improvement of public health. The IMEDS program launched in April 2013 to build upon the progress made on research methodology by the FDA’s Sentinel Initiative and the Observational Medical Outcomes Partnership.

“It is impressive and gratifying to see the progress made in the past few years in the development and evaluation of methods for drug safety research using healthcare data, through the U.S. and related European projects,” Andrews said. “We continue to need improved tools for safety surveillance of medicines, vaccines and biologics. I am excited about being part of the early stages of IMEDS.”

Andrews joined RTI Health Solutions in 2001. She provides consultation to pharmaceutical companies and the FDA on epidemiology and therapeutic risk management. She also directs research programs that evaluate drug safety and the effectiveness of risk management measures. Andrews has worked extensively in the areas of HIV, sexually transmitted diseases, birth defects, and gastrointestinal disorders.

Prior to RTI, Andrews served as the vice president of worldwide epidemiology at GlaxoSmithKline, and worked within the North Carolina Health Department in perinatal care services and management of non-Medicaid reimbursement services.

She is a fellow and past president of the International Society for Pharmacoepidemiology, and serves as an adjunct faculty member at the University of North Carolina at Chapel Hill’s School of Public Health and School of Pharmacy.

Andrews holds a doctorate degree in epidemiology and a master’s degree in public health from the University of North Carolina at Chapel Hill.

 

Highlights

  • Elizabeth Andrews has been appointed to serve as the academia/research institute representative on the Reagan-Udall Foundation, Innovation in Medical Evidence Development and Surveillance (IMEDS) steering committee.
  • The steering committee will play a critical role in governing the IMEDS program’s research and operations.
  • IMEDS builds upon the progress made on research methodology by the FDA’s Sentinel Initiative and the Observational Medical Outcomes Partnership.