EURORDIS (European Organisation for Rare Diseases) launched the Summer School in 2008 to empower patients’ representatives in the areas of clinical trials and EU regulatory affairs. EURORDIS’ training programs and resources are designed to strengthen the capacity of rare disease patients’ representatives.
Training empowers patients’ representatives to advocate effectively for rare diseases at both the local and EU level. EURORDIS Summer School 2013 was held in Barcelona, Spain, on 17-21 of June. The EURORDIS Summer School is organized in collaboration with the Fundacio Dr. Robert and Professor Josep Torrent i Farnell and his team at the Universidad Autonoma de Barcelona. The Summer School is an initiative started by EURORDIS in 2008 and financed by the:
- French Muscular Dystrophy Association (AFM)
- Executive Agency for Health and Consumers (EAHC) Operating Grant
- European Clinical Research Infrastructure Network (ECRIN)
- DIA Philanthropy Programme (2008 -2010)
This four-day course provides training in aspects of medicines development and EU regulatory processes where patients’ representatives can be involved.
The EURORDIS Summer School aims at training patients’ advocates in the areas of :
- Clinical trials
- Medicines development
- Regulatory affairs
The program included:
Day 1. Life-cycle of Drug Development. Principles of clinical trials.
Day 2. Ethics. Post-marketing phases.
Day 3. Regulatory committees and working parties at the European Medicines Agency
Day 4. Regulatory committees cont… EURORDIS research and projects.
Social activities: Welcome dinner on 17th of June, Cocktail evening at Hotel Alimara, Tour of the Cosmo Caixa Museum.
Each day of the summer school started at 9 a.m. and finished at 4 p.m. The schedule usually included lectures, coffee break, small group discussions, lunch, training.
Speakers:
- Fernando de Andres-Trelles, M.D. Member of EMA Paediatric Committee (PDCO), EMA Scientific Advice Working Group, Human Scientific Committees working party with Patients` and Consumers` Organisations (PCWR), Professor of Pharmacology at Madrid`s Universidad Complutense.
- Juan García Burgos, M.D. Section Head for Public Information and Stakeholder Networking in Medical Information.
- Rob Camp. Consultant in patient group of EURORDIS, US AIDS Treatment Activists Coalition (ATAC), Drug Development Committee.
- Monica Ensini. PhD in Neurobiology, Scientific Director at EURORDIS.
- FrançoisHouÿez. Represents EURORDIS at the Patients` and Consumers` Working Party at the EMA
- Drs Eric Koster. Institutional Review Board Twente (ethicist), member of the hospital Ethics Committee.
- Christine Kubiak, PharmD, PhD. Member of European Clinical Research Infrastructure Network (ECRIN)
- Jordi Llinares-Garcia, M.D., MSc. The head of orphan medicines at the EMA
- Professor John Norrie. Professor & Director of the Centre for Healthcare Randomised Trials (CHaRT) at the Health Services Research Unit, University of Aberdeen.
- Patrick Salmon, M.D. CHMP member of the EMA, Irish COMP delegate.
- Markku Toivonen, M.D., PhD. Chaired the EMEA Scientific Advice Working Party, the CPMP Scientific Advice Review Group (SciARG), the CPMP Ad hoc group on (pre-) clinical comparability of biotech products.
- Professor Josep Torrent-Farnell. Member of the Committee for Orphan Medicinal Products (COMP) of the EMA, Scientific Advice Working Party (SAWP) of the EMA, Professor of Clinical Pharmacology and Therapeutics at the Autonomous University of Barcelona, Director General of the Fundacio Doctor Robert, Advanced Centre of Services and Training for Health and Life Sciences.
Participants statistics: A total of 38 participants from 18 countries representing 32 disease interest.
In addition to intense and informative training program all the participants had a great opportunity to share experience, to discuss the problems and the ways of their solving, to keep in touch after the school.
The organization has been at the highest level due to non-stop work of Maria Mavris, Nancy Hamilton and others.
