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Glossary

Risk-benefit balance

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An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. 

Other glossary definitions

I

Incident for IVDMD (IVDR definition)

Any malfunction or deterioration in the characteristics or performance of a device made available on…

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P

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming…

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