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30 June 2021

On 14 June, EFA held its Meet and Greet EU Training on the European Medicines Agency (EMA). This training shed light on how the EMA functions. It also provided meaningful information for EFA Members and expert patients to increase their understanding and involvement in the regulatory processes of medicines development.

The event had more than 28 participants actively participating and engaging in the Q&A sessions. The comprehensive programme delved into how patient advocates and contribute to the EMA's work at various levels. The sessions were led by Maria Mavris, Patient Relations, from the Public and Stakeholder Engagement department of the EMA, and Sabine Straus, Chair of the EMA Pharmacovigilance Risk Assessment Committee. Participants also heard from Susanna Palkonen, Director of EFA and Erna Botjes, EFA’s representative to EMA. Each speaker shared their expertise around patient involvement to offer advice and guidance to the participants.

Ms Mavris provided a comprehensive introduction to EMA and its centralised procedure, discussing EMA’s responsibilities and how different medicines are approved. She also highlighted the progressive journey the EMA has undertaken to involve patients and consumers in their work. Mavris clarified how, and where, patients can be involved in the process, across areas of interest such as rare disease medicines and marketing authorisation. Additionally, she presented avenues for patient involvement in scientific advice procedures and scientific advisory groups, including advice on successful engagement.

Susanna Palkonen and Erna Botjes discussed EMA’s policy on handling competing interests for patient involvement, clarifying direct and indirect interests, and providing guidance for the DoI (Declaration of Interests) form. 

The presentation from Sabine Straus delved into pharmacovigilance, safety monitoring and lifecycle processes of medicines for allergy and respiratory disease. In her presentation, she stressed the importance of patient and healthcare professional participation in stakeholder meetings.  

The participants enjoyed a comprehensive and unique insight into EMA’s work and processes, helping patients and member associations build their capacity to meaningfully engage in processes governing their healthcare. 

Couldn’t make it to the event? You can watch the edited recording on Youtube.

In the meantime, click here for upcoming events and follow EFA on TwitterFacebook or LinkedIn for future trainings.