Either aiming to evaluate the safety and benefit-risk profile of an authorised medicinal product or wish to support regulatory decision-making, a post authorisation safety study (PASS) will help you:
- identify, characterise or quantify a safety concern
- confirm the medicine's safety profile, or
- measure the effectiveness of risk-management measures
PASSs may be imposed by a competent authority or EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) as a condition of the marketing authorization process but also after granting a marketing authorization, if there are concerns about medicinal product’s potential risks.
However, PASS may also be voluntarily initiated to help MAHs evaluate the risks of a medicinal product -or provide evidence about their absence- and in this way develop more effective risk management plans.
In full compliance with the Guidelines on Good Pharmacovigilance Practices (GVP), CORONIS clinical team is very-well experienced to successfully carry out PASS projects: from study protocol development to final study report submission.