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Eurordis - Rare Disease Europe


Conflict of interest in patient engagement

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This online course aims to raise awareness among patients and the engaging stakeholder organisations on the consequences that different patient engagement activities might have on patients. You will learn about best practices related to multi-stakeholder interactions and how each stakeholder could better manage competing interests, and help avoid/minimise conflict of interest by suggesting risk mitigation strategies.

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 the specific guide: Raising awareness on managing competing interests in a multi-stakeholder environment: Guidance to patients and engaging stakeholders.

The first part covers general considerations applicable to all relevant stakeholders and the second part gives specific examples of patient and patient organisations, medicines developers and regulatory and HTA bodies.

At the end of some of the lessons, you’ll find a set of scenarios that will help you hone critical-thinking skills and apply the knowledge gained.

Learning Objectives

With this course you will:

  • understand the difference between competing interests and conflicts of interests;
  • learn how to assess the impact they may have on the process of engagement; and
  • how to manage competing interests using risk mitigation strategies.

Experts that contributed to this course

Read more about the experts

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

Joined EURORDIS in June 2014. Referent for EURORDIS’; activities related to the development of medicines for people living with rare diseases, patient empowerment (e.g. EURORDIS Summer School) and patient engagement in medicines development. Since June 2022, she has been appointed as one of the Civil Society representatives on the Europen Management Agency Management Board. At global level, she is involved in the International Rare Diseases Research Consortium (IRDiRC) since its inception in 2011.

Virginie has 20+ years of work experience in research and healthcare, including 14 years in the rare diseases field – hospital, research lab, academia, European Medicines Agency (as expert) and patient organisation. Notably, prior to joining EURORDIS, she worked 6 years at Orphanet, the international database on rare diseases and orphan drugs (INSERM, France).


Download the glossary for this course.

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