Pharmacoepidemiology

Post-authorisation safety & efficacy studies (PASS/PAES)

We have been contributing to the development and execution of PASS/PAES for several products from various therapeutic areas as part of the PV activities required for products in Europe, following PRAC referrals.

We can support you in all steps of designing and running such studies. We have also been coordinating a consortium of companies having to perform a PASS on a class of products, consisting of 18 companies with over 150 products throughout Europe, 7 data sources in 5 countries, one specialist pharmacoepidemiology partner, including the communication with PRAC and national competent authorities. Having gained the experience of running such an industry consortium with many important learnings along the way puts us in a unique position in the industry to set-up and successfully coordinate similar consortium approaches to safety and efficacy studies. We follow the ENCePP guide on methodological standards in pharmacoepidemiology and the ENCePP Code of Conduct.