Post Authorisation Safety Studies

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.


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