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Glossary

Development safety update report (DSUR)

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Format and content for periodic reporting on drugs under development (ICH-E2F Guideline, Volume 10 of the Rules Governing Medicinal Products in the EU).

Other glossary definitions

R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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M

Market/patient Access

Market access is the definition and achievement of a strategy aiming that all patients included…

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