Tutorial Registration: 12:00 to 1:00 PM
Understanding how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole has become a vital skill for stakeholders. This tutorial will follow the progression of vignettes at three points in the development and post-approval life cycle, showing how a team might utilize various methodologies in context.
(i) Development: As a team locks its assessment content in place, considers what endpoints to use and roughs out an approach for the assessment when only phase 2 data is available
(ii) Peri-approval: As a team uses all data developed during its clinical program to develop Benefit-risk arguments to use in health authority submissions and advisory committee presentations.
(iii) Post-approval in preparation for a PBRER: Using post-approval data sources, developing and presenting an integrated Benefit-risk assessment.
At the conclusion of this tutorial, participants should be able to:
Describe how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole
Recognize and gain familiarity with the utility from different methods for Benefit-risk assessment at different points in the development life cycle
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