EURORDIS Summer School for patient advocates
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The Summer School is an initiative started by EURORDIS in 2008 and financed by the:
- DIA Philanthropy Programme,
- Executive Agency for Health and Consumers (EAHC) Operating Grant
- French Muscular Dystrophy Association (AFM)
It aims at training rare disease patients' representatives in the areas of :
- Clinical trials,
- Drug development
- Regulatory affairs.
This preparation builds participants' capacities to act as experts in regulatory processes for their disease and to further their implication in drug development and advocacy actions.
An annual event in Barcelona
Since its inception, the EURORDIS Summer School has collaborated on this project with the Fundacio Dr. Robert headed by Professor Josep Torrent i Farnell and his team of the Universidad Autonoma de Barcelona (UAB). Every year the Summer School is held in Barcelona, Spain and to date has welcomed over 150 participants from more than 25 different countries representing over 45 rare diseases.
Participants are selected by an ad hoc committee according to their level of English language skills, their experience in rare disease advocacy, and their willingness to be involved in drug development and regulatory affairs at the European level.
In this unique training course tailored for EU patients' representatives, the material is presented by experts with extensive experience and enables participants to put together a complete picture of drug development from clinical trials to market authorisation.
Positive results, greater understanding, further involvement
Summer School participants' feedback includes an increased awareness of the importance of their involvement in all aspects of drug development and their potential to be a real force. Participants also stressed the need for international collaboration of patients' associations in these activities and the importance of familiarity with the activities of the European Medicines Agency (EMA) as well as EURORDIS.
An on-line e-learning tool has been developed that supports the content of the Summer School in clinical trials and drug development.
Prior to the EURORDIS Summer School, these patient advocates felt isolated and alone in their cause. There was no opportunity to meet others and interact with stakeholders to exchange information and experiences.
The EURORDIS Summer School has enabled these interactions, reinforced their sense of community, and increased their individual capacities.
The EMA and Summer School
In 2000 the Committee for Orphan Medicinal Products (COMP) was formed at the European Medicines Agency (EMA) and the European authorities had the foresight to include patients' representatives as permanent and full members with equal voting rights. Three patients' representatives sit on this committee and the position of Vice-Chair of the COMP has to date always been held by a patients' representative.
Since this time, a working party and two more scientific committees were created:
- Patients' and Consumers' Working Party (PCWP) (2006),
- Paediatric Committee (PDCO) in 2008,
- Committee for Advanced Therapies (CAT) in 2009,
all of which include patients' representatives.
In addition, rare disease patients are also frequently solicited as experts on a sporadic basis for their input on the development of specific products for their disease e.g. via the process of protocol assistance with the Scientific Advice Working Party (SAWP).
Further to their regulatory role, activities of patients' representatives (advocates) in the framework of therapeutic development include:
- Promoting drug development,
- Ensuring clear information to patients,
- Attempting to achieve equal access to treatments both at European and national levels.
This motivated EURORDIS, who has permanent representatives in the COMP, PDCO, CAT and the PCWP and is consulted for protocol assistance in the SAWP, to evaluate how best to continue supporting these patients' advocates. A training course providing an overview of clinical trials, drug development and regulatory procedures was identified as an essential tool to address these needs - hence the EURORDIS Summer School was born.
For more information about EURORDIS Summer School please contact Maria Mavris maria.mavris@eurordis.org
The Eurordis Summer School for Patient Advocates is made possible thanks to the generous support of:
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Developed with the support of:
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Author: EURORDIS
Photos: © EURORDIS
