Either aiming to evaluate the safety and benefit-risk profile of an authorised medicinal product or wish to support regulatory decision-making, a PASS will help you:
- identify, characterise or quantify a safety hazard;
- confirm the safety profile of a medicine, or;
- measure the effectiveness of risk-management measures.
PASSs may be imposed by a competent authority or EMA’s Pharmacovigilance Risk Assessment Committee as a condition of the marketing authorization process but also after granting a marketing authorization, if there are concerns about product’s potential risks.
However, PASS may also be voluntarily initiated in order 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 Guideline 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.