Beyond the Risk Management Plan

Additional Risk Minimisation Measures and Due Diligence

• Risk minimisation across the product lifecycle 
• Routine vs. additional RMMs: European regulatory background 
• Types and implementation of aRMMs: Educational materials, checklists, patient agreements; design, approval, distribution, and oversight
• Governance and regulatory roles: Responsibilities of MAHs and authorities, monitoring, and effectiveness evaluation 
• Examples: Thalidomide analogues, endothelin receptor antagonists

The aim of this seminar is to provide participants with a solid understanding of the regulatory requirements and practical implementation of risk mini- misation measures (RMMs) within pharmacovigilance. In addition to routine RMMs, such as the Summary of Product Characteristics and Package Leaflet, the seminar focuses on additional risk minimisation measures (aRMMs), which are often required for higher-risk medicinal products.

A particular emphasis is placed on the complex implementation of Pregnancy Prevention Programmes (PPPs) for teratogenic substances. Using a case study based on thalidomide analogues and endothelin receptor antagonists, the seminar illustrates regulatory expectations, practical challenges, and effective solutions for designing and implementing PPPs.

The objective is to enable participants to systematically identify risks, plan appropriate risk minimisation measures, implement them in a regulatory- compliant manner, and evaluate their effectiveness.