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Eurordis - Rare Disease Europe


Recommendations on the required capabilities for patient engagement

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This online course provides recommendations on the competencies (understood as knowledge, skills and behaviours) and resources that each stakeholder organisation should aspire to have in place in order to plan, implement and evaluate meaningful and sustainable patient engagement activities across the medicines lifecycle.

This course is based on one of the main outcomes of the IMI funded multi-stakeholder consortium PARADIGM (Patients active in research and dialogues for an improved generation of medicines). The Patient Engagement Toolbox centralises all PARADIGM’s co-created recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. This course focuses on a specific guide: Recommendations on the required capabilities for patient engagement

This online course does not address the specific competencies of the patient participants involved in patient engagement activities.

Learning Objective

The objective of this online course is to increase the preparedness of stakeholder organisations by identifying the capabilities required by those individuals involved in implementing patient engagement activities and the resources (processes, tools and systems, organisational structure) needed within the organisation.

Experts that contributed to this course

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Maria Cavaller, EURORDIS

Maria is part of the EURORDIS Patient Engagement team. She manages the process of patient engagement in medicines development procedures at the European Medicines Agency (EMA), mainly protocol assistance and coordination of patient engagement for European initiatives namely PARADIGM, C4C and MoCA. She also supports the work of the members of the EURORDIS Therapeutic Action Group, and work on topics linked to therapeutic development.


Virginie Hivert, EURORDIS

Virginie is responsible for following the development of orphan medicinal products as an observer on the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency. She coordinates the group of high-level EURORDIS representatives/volunteers who sit on the various scientific committees/working parties at the EMA, known as the Therapeutic Action Group (TAG) and is herself the alternate member representing patients on the Pharmacovigilance and Risk Assessment Committee (PRAC).

Virginie is responsible for two activity areas in EURORDIS, one being the training of patients’ representatives in therapeutic development activities (EURORDIS Summer School, EUPATI) and the other related to their engagement in these activities (in Protocol Assistance in Scientific Advice Working Party (SAWP) at the EMA for example)

She is also Vice-Chair of the Therapies Scientific Committee of IRDiRC (International Rare Disease Research Consortium).




Download the glossary for this course.


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