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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

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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