Jonathan Morris | Vice President, Evidence Development
UBC

The EMA regulatory reporting requirements for marketed biopharmaceutical products have changed.  Periodic update reports that used to focus on case line listings, safety, and safety assessment now must also address periodic updates to product benefit, and include a formal assessment of benefit-risk.  Multi-Criteria Decision Analysis (MCDA) has been identified as a cornerstone of the methodology used for the quantitative modeling of a product’s benefit-risk profile.  The presentation will focus on the new content requirements, the implementation of MCDA modelling with marketed products, and the impact of the new regulations on content and membership of Safety and PV teams.

• › Jonathan Morris, Vice President, Evidence Development, UBC