Overview

The proactive planning of risk minimisation measures (RMMs) in the context of optimizing the benefit-risk profiles of medicinal product is a challenging task. RMMs should be commensurate to the risk in relation to the clinical benefit of the product and should work for the intended patient population without adding undue burden on the healthcare systems. They should also allow for rapid evaluation of their effectiveness and adaptation to a changing healthcare environment, if and when necessary.
In this course, we will share experiences and challenges in designing, implementing, and evaluating RMMs in different regulatory settings and different therapeutic areas, as well as presenting an outlook on what may be the next generation of RMM tools.

Featured topics

- Introduction to risk management
- Regulatory framework for risk management
- Designing a risk minimisation measures strategy
- Tools for risk minimisation
- Implementation of risk minimisation measures
- Measuring effectiveness
- Risk minimisation measures findings from an assessor’s perspective
- Evolving landscape and future outlook

Who should attend?

This intermediate level virtual live training course is intended for professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, risk management and regulatory affairs. Ideally, participants should have an experience in risk management.

Learning objectives

At the conclusion of this virtual live training course, participants will be able to:
- Design a risk management strategy
- Select the appropriate tools for risk minimisation
- Choose the right measures to evaluate effectiveness

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Risk Minimisation Measures