Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risks
12-13 June 2014, Washington DC, USA
The discussion at this workshop centred on how utilising an overarching framework that covers pre-, peri- and post-approval periods of a product’s lifespan can enable an improved understanding of the changing benefit- risk profile as knowledge increases about a new medicine. The challenges, hopes and expectations of structured approaches to evaluating the evidence in balancing benefit-risk in the post-approval period were also explored along with evaluating methodologies that would be feasible for companies and acceptable to agencies to provide information on the benefits of a new medicine in the post-approval period. This workshop also provided an update on the various regulatory methodologies to assess benefits and harms with a focus specifically on both company and agency experience in using a structured approach and how this can translate to the post-approval phase.
Workshop objectives
- Discuss how a universal framework aligns to the structured benefit-risk assessment of medicines across the pre-, peri- and post- approval periods
- Identify appropriate methodologies for producing Periodic Benefit Risk Evaluation Reports (PBRERS) as well as the challenges and solutions
- Recommend how best to assess benefits i the post-approval period.