Speaker: Bennett Levitan, MD-PhD.  Senior-Director, Benefit-Risk Assessment. Department of Epidemiology. Janssen R&D, LLC.

Abstract:

Assessing the B-R balance of medical treatments has always been an integral part of public health, drug development, and regulatory decisions.  However, methodology and regulatory policies for B-R have advanced considerably in the last decade. Structured B-R frameworks are implemented in regulatory review by FDA and EMA and are required in new drug applications and in post-approval periodic benefit-risk evaluation reports (PBRERs) per ICH guidance documents.  In parallel, numerous B-R initiatives have been led by pharmaceutical organizations, patient advocacy groups, public-private partnerships and academic groups.  These efforts have resulted in new qualitative and quantitative approaches to B-R and summaries of approaches and recommendations.  This Webinar will provide an overview of these efforts.  Methods to assess B-R with be introduced, including applications of structured frameworks, B-R tabular summaries, and graphical displays that have become an integral part of B-R assessments and regulatory submissions.