1. European Patients’ Academy on Therapeutic Innovation Aspects of pharmacovigilance: Post-Authorisation Safety Studies (PASS)

2. European Patients’ Academy on Therapeutic Innovation  A PASS is a study carried out after a medicinal product has been authorised, in order to obtain further information on a medicinal product’s safety or to measure the effectiveness of risk-management measures  The purpose of the PASS is to evaluate the safety and benefit-risk profile of a medicinal product and to support regulatory decision-making  The protocols and results of PASSs are assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) 2 What is a Post-Authorisation Safety Study (PASS)?

3. European Patients’ Academy on Therapeutic Innovation  A PASS aims to  Identify, characterise, or quantify a safety hazard;  Confirm the safety profile of a medicine; or,  Measure the effectiveness of risk-management measures.  PASSs can either be clinical trials or non-interventional studies. 3 Scope of a PASS

4. European Patients’ Academy on Therapeutic Innovation  European Medicines Agency (2015). Post-authorisation safety studies (PASS). Retrieved 29 September, 2015 from http://www.ema.europa.eu/ema/index.jsp?curl=pages/re gulation/document_listing/document_listing_000377.jsp& mid=WC0b01ac058066e979 http://www.ema.europa.eu/ema/index.jsp?curl=pages/re gulation/document_listing/document_listing_000377.jsp& mid=WC0b01ac058066e979 4 Further reading