CRED Understanding Clinical Development 2024

09/10/2024

Risk Management Plan (RMP)

Risk minimization Plan

• defines appropriate measures to minimize the known risks and monitor the success of those measures. • Routine risk minimisation (SmPC) • Additional risk minimisation (for very important serious risks) – Educational programs (for Healthcare Professionals, patients, and caregivers) – Dear Healthcare Professional Communication – Pregnancy Prevention Programs

– Controlled Access Programs – Controlled Distribution System

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Post Marketing PV

• What we know at the end of the clinical trial programme…

What we don’t know!

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• What happens when the use of medicinal product is used in normal practice (not controlled conditions) • Limited numbers of patients studied in clinical trials

The Organisation for Professionals in Regulatory Affairs

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