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Glossary

Identified risk

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An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

Other glossary definitions

C

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure…

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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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