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Glossary

Appropriately Reduce (risk)

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The reduction of risk to an acceptable level as determined by the manufacturer and regulatory authority (reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or reducing risk as far as possible) without adversely affecting the benefit-risk ratio. 

Other glossary definitions

V

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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R

Risk minimization measure

Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure…

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