RAPS Indiana Chapter: Optimizing Communications with the Office of Surveillance & Epidemiology

When:  Mar 9, 2017 from 17:30 to 20:00 (ET)

Come join us to connect with others from your local regulatory community and hear an interactive presentation from a senior FDA representative about processes and procedures of the Office of Surveillance and Epidemiology (OSE) within the Center of Drug Evaluation and Research (CDER). This session is brought to you by the RAPS Indiana Chapter and is intended to promote engagement between government, industry and academia.

This presentation will provide an overview of the OSE, the role of OSE in the continuum of drug safety lifecycle management and will include recent operational updates, and anticipated updates, from PDUFA VI. The audience will also 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.

Don’t miss this unique opportunity to network with others from your region and to ask specific questions to an agency representative. A light meal will be provided. RAC holders may claim two RAC recertification credits.