ExPRESS 2017 Expert Patient and Researcher EURORDIS Summer School
Patients are taking on ever increasing roles in advocating for medicines development, equal access to treatments across Europe and ensuring that medical information is clear, accurate and comprehensible. In order to help prepare them for these roles and as part of its commitment to empowering people living with rare diseases, EURORDIS launched its own training programme for expert patients in 2008.
The programme allows patients and researchers to sharpen their advocacy skills and gain an understanding of the regulatory process of orphan medicinal products so that they are able to advocate at a European level.
The programme has online and face-to-face components. The face-to-face portion trains 40 expert patients annually as part of an intensive 4.5-day course held in Barcelona, Spain.
The Summer School was developed to fill specific needs identified by expert patients, EURORDIS and the European Medicines Agency. Expert patients from EURORDIS are permanent representatives on EMA Scientific Committees and working parties. EURORDIS recognises their need for support and training that includes an overview of clinical research and methodology, medicines development and regulatory procedures.
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 three more scientific committees have been created, all of which include patients' representatives:
Patients' and Consumers' Working Party (PCWP) in 2006
Paediatric Committee (PDCO) in 2008
Committee for Advanced Therapies (CAT) in 2009
Pharmacovigilance and Risk Assessment Committee (PRAC) in 2012
Expert Patients are also frequently solicited 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).
To date, the Summer School has trained over 300 participants from more than 40 countries and representing over 70 different diseases. Summer School alumni report an increased awareness of the importance of their involvement in all aspects of medicines development and of their potential to be a real force. Participants also recognise the need for patients' organisations to collaborate internationally as well as the importance of involvement in the activities of the European Medicines Agency (EMA) and EURORDIS. The training experience reinforces participants' sense of community, and increases their individual capacities.
Ahead of the Summer School in Barcelona, participants are invited to take part in a pre-training course. In addition to the face-to-face training programme, trainees have access to freely available on-line modules, webcasts and slide presentations to allow them to prepare for the face-to-face training and to review and refer back to the content once they have completed the training.