PASS & PAES Studies
We support you in the design and running of your Post Approval studies
We follow the ENCePP guide on methodological standards in pharmacoepidemiology and the ENCePP Code of Conduct to support you in the design and running of PASS or PAES studies.
A post-authorisation safety study (PASS) is carried out after a medicine has been authorised to obtain further information on its safety or to measure the effectiveness of risk-management measures.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results. The purpose of these studies is to evaluate the safety and benefit-risk profile of a medicine and support regulatory decision-making.
OXON provides clients with a powerful and almost unique combination of clinical, PRO, health economic, methodological and statistical expertise, resulting in creative solutions to best serve clients to:
• identify, characterise or quantify a safety hazard;
• confirm the safety profile of a medicine, or;
• measure the effectiveness of risk-management measures.
A post-authorisation efficacy study (PAES) refers to studies performed after marketing authorisation when there are concerns relating to some aspects of the efficacy of the product, or when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be modified significantly.
In Europe a PAES can be imposed during evaluation of initial MAA or during PA phase whenever there are doubts on efficacy.