Designing studies for risk management plans that are acceptable to European regulators
Saad Shakir addresses the challenges of proposing post-authorisation safety (PAS) studies for risk management that would be approved by regulators: Designing and proposing studies for risk management plans (RMPs) requires more than knowledge about the relevant GVP modules and the template.The process needs strategic thinking that requires understanding of:
The pre-marketing data for the product - more importantly the known unknowns.
Studies proposed in the RMP are essentially to reduce uncertainties about such known unknowns, as well as addressing concerns about the safety when the product is used post-marketing in a population which is likely to be different from those who received the product pre-marketing.
Experience required to be built over time regarding which studies will be needed for RMPs that will be accepted by PRAC and be seen by the regulators to be capable of answering the relevant questions.
Such experience definitely includes pharmacoepidemiological know-how, but also experience with strategic approaches to answer the relevant regulatory questions.
All studies proposed to PRAC by the DSRU have been approved.