On March 9th, the RAPS Indiana Chapter, chaired by Pearl Pathways COO Gretchen Bowker, will host an interactive presentation from a senior FDA representative. The FDA representative, Jill R. Bourdage, RPh, PMP, will speak about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). The presentation will provide an overview of the OSE and its role in the continuum of drug safety lifecycle management. Anticipated updates from PDUVA VI will be covered and the audience will learn how the role of the OSE Safety Regulatory Project Manager and regulatory expert as point of contact for industry can help achieve optimal communication.
Presentation title: Optimizing Communications with the Office of Surveillance & Epidemiology
Date: March 9, 2017
Time: 5:30 – 8:00pm EST
Location: Purdue University: Seng Liang Wang Hall
West Lafayette, IN
Registration and more information about the content can be found here.