ExPRESS 2016 Expert Patient and Researcher EURORDIS Summer School

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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 preparing 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 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.

In 2015, the Summer School was given a new name, “Expert Patient and Researcher EURORDIS Summer School” or ExPRESS, to reflect that researchers can also apply to take part in course.

The next session will be held from 6-10 June 2016 in Barcelona. The deadline for applications is December 31, 2015

1. Why the Summer School was developed

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).

2. Content of the programme

The EURORDIS Summer School covers the follow topics:

Clinical Trials Methodology
Clinical Research
Ethical Considerations in Medicines Development
Regulatory affairs
Health Technology Assessment
Marketing Authorisations

3. Financial support

The Summer School is financed by:

2008 to 2010 DIA Philanthropy Programme
2008 to 2016 French Muscular Dystrophy Association (AFM)
2008 to 2016Inserm
2008 to 2015 Fundació Doctor Robert UAB
2008 to 2016 Executive Agency for Health and Consumers Operating Grant
2012 to 2016 European Clinical Research Infrastructure Network (ECRIN)
2013 to 2016Platforma Malalties Minoritaries
2015 and 2016 Cost Action Exon Skipping BM1207

This valuable support allows EURORDIS to cover the costs of training materials meeting rooms, technical and logistics support, accommodation, economy class travel and most meals for all attendees.

4. How to apply

Below you will find links to a) the letter for applicants, b) preliminary programme, and c) the application form. Participants are selected by an ad hoc committee according to their, their advocacy experience, their willingness to be involved in medicines development and regulatory affairs at the European and their English language skills.

5. Alumni

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.

6. Other training

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.

For more information about EURORDIS Summer School please contact Nancy Hamiltonnancy.hamilton@eurordis.org