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Glossary

Risk minimization measure

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Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. 

Other glossary definitions

P

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define…

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P

Patient Reported Outcome (PRO)

A measurement based on a report that comes directly from the patient (i.e., study subject)…

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