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SWECRIN Meeting September 2008 ECRIN - Future challenges and visions Christian Gluud, DCRIN The Copenhagen Trial Unit

SWECRIN Meeting September 2008 ECRIN - Future challenges and visions Christian Gluud, DCRIN The Copenhagen Trial Unit Rigshospitalet. ECRIN challenges. ECRIN challenges - human resources. ECRIN challenges - human resources. ECRIN challenges - human resources. ECRIN challenges

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SWECRIN Meeting September 2008 ECRIN - Future challenges and visions Christian Gluud, DCRIN The Copenhagen Trial Unit

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  1. SWECRIN Meeting September 2008 ECRIN - Future challenges and visions Christian Gluud, DCRIN The Copenhagen Trial Unit Rigshospitalet

  2. ECRIN challenges

  3. ECRIN challenges - human resources

  4. ECRIN challenges - human resources

  5. ECRIN challenges - human resources

  6. ECRIN challenges - different regulation in all 27 countries

  7. ECRIN challenges - The trial directive (2001/20/EC) has been variably transposed into the EU countries regulation - The ‘ethical values’ differ

  8. ECRIN challenges - The greedy firms

  9. ECRIN challenges - The greedy firms We got to make them understand that they are practising ‘neocolonialism’ They expropriate patient’s data and sell back the drug

  10. ECRIN challenges - The greedy physicians

  11. ECRIN challenges - The greedy physicians We got to make physicians agree that clinical research must be part of clinical work, ie, live up to our Hippocratic oath!

  12. ECRIN will meet a lot hot lave…..

  13. ECRIN will get problems

  14. ECRIN’s vision:

  15. ECRIN’s Mission Statement

  16. Ecrin’s Mission StatementWe arethe European infrastructure for clinical research, facilitating clinical research in the European Union, taking advantage of its population size and of its high healthcare standards, andimproving quality and transparency for the benefit of patients, citizens, and healthcare systems

  17. Vision • ECRIN provides an integrated ‘one-stop shop’ support to investigators and sponsors in multinational clinical research, • for any category of clinical research, • in any disease area, • particularly in rare diseases where • multinational collaboration is a • critical success factor

  18. Vision • ECRIN promotes the development of national networks of clinical research centres and clinical trial units with professional staff and data management tools, implementing high quality • standards in the conduct of clinical studies

  19. CRC = Clinical Research Centre DM = Data Centre EC = European Correspondent NNC = National Network Coordination GMP= GMP facilities for biotherapy

  20. Vision • ECRIN promotes education and training, • as well as mobility programmes between countries, • between preclinical and clinical research, and between academia and industry

  21. Vision • ECRIN facilitates the connection of disease-oriented networks across borders

  22. Vision • ECRIN promotes sound, unbiased methodology ensuring optimal protection of trial participants and high ethical standards

  23. Vision • ECRIN promotes availability of EU funding to clinical research

  24. Vision • ECRIN promotes harmonisation of national legislation on clinical research and the development of a European regulatory framework providing optimal protection for the trial participants and minimal obstacles to medical institutions, through requirements adapted to the risk of the • individual trial

  25. Vision • ECRIN promotes transparency and optimal use of data through public registration of clinical studies, transparent reporting, and the development of public repositories for clinical study data

  26. Vision • ECRIN promotes the active participation of patients in clinical research, through their involvement in every step including the initiation and design of clinical studies

  27. Vision • ECRIN promotes communication on the challenges raised by clinical research with patients, families, citizens, ethics committees, competent authorities, academic and industry sponsors, • news media, national and EU policy makers, and other stakeholders

  28. Vision • ECRIN acts synergistically with the other EU biomedical infrastructures involved in preclinical research and biobanking, promoting common strategies, shared procedures and interoperable • data, thus providing a comprehensive support to biomedical science in the EU

  29. Vision • ECRIN plans extension to all the EU member and associated states, develops partnership with clinical research infrastructures in other world regions, and with developing countries through its • capacity building programme

  30. ECRIN website http://www.ecrin.org/

  31. Thank you!

  32. This multinational and distributed infrastructure makes the European Union an integrated area for clinical research, unlocking latent scientific potential, spreading best practices and highest quality standards, thus fostering the attractiveness of Europe for clinical research and increasing the competitiveness of European biomedical research for academic institutions, small- and medium sized enterprises, and health industry

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