Post Authorisation Efficacy Studies

PAES is a post authorisation efficacy study requested by a Competent Authority in order to complement the available efficacy data.

A PAES may be imposed at the time of granting the initial marketing authorisation, in order to contribute to the resolution of some identified efficacy concerns which can only be achieved after the medicinal product has been marketed.

A PAES, however, may be also imposed after marketing authorization granting, when the understanding of the disease or the clinical methodology or the use of the medicinal product under real-life conditions indicate that previous efficacy evaluations might have to be revised or further evaluated.

CORONIS clinical team can fully undertake the conduct of the study and the submission of the final study report but also the evaluation of final results' impact on the marketing authorisation.

Depending on evaluation’s results, CORONIS medical team will provide consultation on the proposed changes to the medicinal product information and update the periodic safety update report (PSUR) with a summary of the clinically important efficacy and safety findings.



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