CRED NPM

05/11/2024

Risk minimisation and educational measures

• Risk Management Plan (RMP)

Safety Specification

• Important Identified Risks • Important Potential Risks • Important Missing Information

Pharmacovigilance Plan / Activities

• Describes the PV activities and action plan for each safety concern • Routine: collecting adverse drug reactions • Additional: PASS studies, measuring effectiveness of RMMS

Risk Minimisation Plan / Measures

• The RMM Plan details the safety concerns for which RMM activities are proposed and discusses routine requirements and any additional provisions • Routine: SPC and Patient information leaflet • Additional: Provision of Safety Measures e.g. training or checklists

The Organisation for Professionals in Regulatory Affairs

23

Risk minimisation and educational measures

• Risk Minimisation Measures (RMMs)

➢ Strategies to minimise the impact of specific safety concerns

The Organisation for Professionals in Regulatory Affairs

24

12