At FDA, Dr. Neyarapally serves on multi-disciplinary scientific working groups, develops scientific/regulatory guidance documents, works on postmarket drug safety projects, and conducts regulatory science research. From 2007 to 2008, he worked on CER initiatives and projects as an AHRQ Fellow.
Dr. Hammad is currently Deputy Div. Director of the Div. of Epidemiology, Office of Surveillance & Epidemiology, CDER, FDA. He has authored over 40 peer-reviewed publications and holds several academic appointments, spanning various medical disciplines.
Nancy A. Dreyer is Chief of Scientific Affairs and Senior Vice President at Outcome, in Cambridge, Massachusetts and St. Prex, Switzerland. Dreyer and her teams conduct observational research on comparative effectiveness and safety, and quality improvement, and are active in methods development.
Alexander Walker, World Health Information Science Consultants (WHISCON), United States
At FDA, Dr. Neyarapally serves on multi-disciplinary scientific working groups, develops scientific/regulatory guidance documents, works on postmarket drug safety projects, and conducts regulatory science research. From 2007 to 2008, he worked on CER initiatives and projects as an AHRQ Fellow.
Description
The assessment of the benefits and risks associated with drug exposure take into consideration data from pharmacoepidemiologic studies and from other data streams. This forum will address potential applications of quality assessment tools to the evaluation of pharmacoepidemiologic safety studies and the development of a tool to assess observational CER studies. A panel will discuss these issues and their implications.
Learning Objectives: Discuss issues pertaining to the availability and potential application of quality assessment tools for evaluating pharmacoepidemiologic safety studies Explain the development of a tool for the assessment of epidemiologic comparative effectiveness studies under the GRACE (Good Research for Comparative Effectiveness) initiative.