Advancing medicines safety: EMA’s revised risk minimisation measures and the role of patient engagement

In July 2024, the European Medicines Agency (EMA) issued its revised guideline on Good Pharmacovigilance Practices (GVP) Module XVI and its Addendum II. The update places greater emphasis on the involvement of healthcare professionals and patient representatives in the design, testing, dissemination of risk minimisation measures (RMMs), as well as the evaluation of their effectiveness.

While routine RMMs, such as the summary of product characteristics and package leaflet, can be sufficient to manage most risks for medicines, some may require the use of additional RMM tools. And although the selection and design of RMMs is a shared responsibility between medicines regulators and marketing authorisation holders, healthcare professionals and patients play a key role in ensuring that they are integrated and adopted into practice. By establishing processes to enhance the engagement of healthcare professionals and patients, the revised guideline aims to ensure that RMMs are scientifically robust, practical, and effective in everyday clinical practice.

This collaborative model underscores the critical importance of educating healthcare professionals and patients to drive change of behaviours and practices amongst clinicians and patients through integration in healthcare processes.

EMA has a longstanding history of involving patients in its core activities and integrating their perspectives, from scientific advice early in development, evaluation of marketing authorisation applications to post-authorisation activities. Enhancing the relevance and accessibility of safety information and improving patient outcomes can only strengthen the pharmacovigilance ecosystem.

Morgane De Verdiere, European Medicines Agency, NL

My name is Morgane De Verdiere and I am the head of the Medical and Health Information service better known within the European Medicines Agency as the Medical Writers team.

I trained as a pharmacist in Paris and moved to the UK in early 2000 to work in Regulatory Affairs for a pharmaceutical company. I joined EMA in early 2006, working in the

Committee for Medicinal Products for Human Use (CHMP) secretariat for several years. After a stint in our Access to Document service, I moved to my current role in 2019 where amongst other things I oversee all medicines-related content that we publish in lay language.

At EMA, writing is a big part of our work and communicating clearly is a strength we cultivate and share internally. I am a strong believer that anyone can get better at writing clearly.