Modern Risk Minimisation for Safety Professionals

In this online seminar, you will learn how to design, implement and evaluate effectively (additional) risk minimisation measures (RMMs). You will gain a clear understanding of current regulatory expectations based on GVP Module XVI (Rev 3) and Addenda I and II, and learn how additional RMMs are selected, developed and monitored in practice. Save your seat now

• GVP Module XVI (Rev 3) and Addenda I and II
• Routine and additional RMM
• Evaluating the effectiveness and user-testing of RMM
• Risk minimisation for medicinal products with embryo-fetal risks
• Global risk management strategy and regulatory expectations

This training course will be conducted in English.

This online training course is designed for professionals involved in risk minimisation activities at a pharmaceutical MAH within the EU and/or globally. It is particularly relevant for colleagues working in pharmacovigilance, drug safety, risk management and regulatory affairs. Participants should already have experience in risk management.

This compact online seminar provides a comprehensive overview of modern risk minimisation in the context of patient safety and pharmacovigilance. You will gain a solid understanding of the practical application of the current regulatory framework, defined in:

• GVP Module XVI - Risk minimisation measures (Rev 3) (06/08/2024),
• GVP Module XVI Addendum I - Risk minimisation measures for medicinal products with embryo-fetal risks (29/08/2025), and
• GVP Module XVI Addendum II - Methods for evaluating effectiveness of risk minimisation measures (06/08/2024).

The course offers a refresher on RMM and a detailed deep dive into aRMM, with a particular focus on the updates released in 2024 and 2025. Key elements include effectiveness evaluation, user testing and pregnancy-prevention programmes. The seminar combines clear regulatory guidance with practical insights, enabling attendees to strengthen their skills in planning, managing and monitoring aRMM within their organisations.

After attending, you will:

• Understand the structure, purpose and regulatory basis of routine and additional RMM.
• Be able to plan and implement aRMMs in alignment with GVP Module XVI (Rev 3) and Addendum I.
• Know how to design materials, engage stakeholders and document relevant steps.
• Apply research methods confidently to evaluate user understanding and RMM effectiveness according to GVP Module XVI and Addendum I and II.
• Recognise regulatory expectations and typical findings.
• Contribute effectively to global risk management strategies within your organisation.