Module 6

03/10/2024

EU & US steps to risk management

Risk Assessment based on existing data

How to evaluate risks after launch

How to mitigate risk after launch

Safety

Pharmacovigilance Plan

Risk minimization Subset of risks

specification

EU Risk Management Plan (all new products and new indications/safety concerns for approved products)

US Pharmacovigilance Plan

US Risk Evaluation & Mitigation Strategy (some products)

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Examples of additional risk minimisation activities

• Thalidomide, lenalidomide, pomalidomide & valproate PPPs – pregnancy prevention programmes Mueller M, Lewis DJ. Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide. Ther Innov Regul Sci. 2021 Nov;55(6):1155-1164. doi: 10.1007/s43441-021-00327-3.

• Controlled access to drug - clozapine patient monitoring system registers patients and prescribers

• Communication to healthcare professionals (DHCP correspondence)

• Educational materials targeting prescribing physicians

• Increased patient monitoring where a known risk exists

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