PRA Late Phase Expert to Present at Conference Strategic Recommendations for REMS Programs
RALEIGH, N.C., Sept. 20, 2012 /PRNewswire/ -- PRA, a leading Clinical Research Organization, announces that one of our Late Phase experts will speak at the 15th annual CBI Registries and Post-Approval Studies Congress being held in Chicago from 19-21 September.
On 21 September at 9:15AM CDT, Dat Nguyen, Scientific Affairs Director of PRA's Late Phase Services group, will deliver a presentation titled, "The Reality of REMS – Implementation and Impact." His speech will address the FDA's guidance for REMS programs stemming from the implementation of the 2007 amendment to the Food, Drug, and Cosmetic Act. Specifically, Dr. Nguyen will present a case study that reviews current trends and operational considerations for REMS programs, including execution challenges and proactive solutions to meet regulatory requirements.
An experienced research scientist, Dr. Nguyen possesses extensive knowledge of the global drug development process with an emphasis on post-marketing and minimal risk studies. His background includes a number of positions in the pharmaceutical industry and activities spanning from initial study design to authoring major publications. In his current role at PRA, Dr. Nguyen utilizes his expertise to provide strategic and innovative post-marketing and minimal risk design, as well as operational support to ensure proper study execution.
PRA's Late Phase Services group supports global and regional post-approval studies with management locations centralized in PRA's Horsham, Pennsylvania; Mannheim, Germany; and Singapore offices. This highly experienced team assists clients with the post-marketing process by planning and conducting safety-surveillance studies, large simple trials, registries, restricted access programs, risk management programs, and diagnostic and biomarker research.
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 30+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.