Wednesday 18 March 2009

14.00 - Opening
- Alastair Kent, EPPOSI Chairman

Session 1: Current situation of registries in Europe
Chairs: Tsveta Schyns and Elisabeth Hernberg-Stahl

14.10 - Setting the scene: State of Art in Europe
- Ségolène Aymé, INSERM / Orphanet
èPresentation and analysis of the current situation of patient databases in Europe

14.30 - European Commission perspectives
- Antoni Montserrat, EC, DG Sanco
- Catherine Berens, EC, DG Research

14.50 - Value of Registries from the point of view of stakeholders
- Christine Lavery, MPS
- Charles Hay, Manchester Royal Infirmary
- Danielle Dols, Genzyme
èPresentation and analysis of established positive results obtained thanks to the existence of registries

15.35 - Debate

16.05 - Coffee Break

Session 2 : Challenges for registries from the point of view of stakeholders in Europe
Chairs: Christel Nourissier and Herwig Jansen

16.25 - Issues at stake from the point of view of stakeholders
- Tsveta Schyns, ENRAH
- Stuart Tanner, EUROWILSON
- Hartwig Gajek, Baxter
èPresentation and analysis of the difficulty to establish and maintain registries

17.10 - Debate

17.40 - End Day 1

20.00 – Dinner
 

Thursday 19 March 2009

Session 3 : Issues at stake with registries in Europe
Chairs: Cees Smit and Atul Mehta

9.00 - Partnerships: Success stories and Challenges
- Maryze Schoneveld van der Linde, International Pompe Association
- Bodo Grimbacher, ESID, University Hospital Freiburg
- Elizabeth Hernberg-Stahl, Shire HGT
èPresentation of successes and difficulties faced when establishing partnerships, between countries and between stakeholders

9.45 - Debate & identification of concrete recommendations

10.45 - Coffee Break

Session 4 : Registration of Patient Data: Legal and ethical issues
Chairs: Christine Lavery and Catherine Berens

11.00 – Registration of Patient Data: Legal and ethical issues
-  Simon Woods, Newcastle University
-  Jasper Bovenberg, Academic Medical Centre Amsterdam (TBC)

12.00 - Debate & identification of concrete recommendations

12.30 - Lunch

Session 5 : Data collection, management and analysis
Chairs: Christophe Beroud and Samantha Parker

13.30 - Data collection, management and analysis: technical issues
-  Paul Landais, CEMARA
-  Denis Costello, EURORDIS
-  Industry Representative, TBI
è What are the issues regarding technical platforms?

14.30 - Debate & identification of concrete recommendations

Session 6: Governance of registries
Chairs: Antoni Montserrat and Kerstin Westermark

15.00 - Governance of registries from the point of view of stakeholders
-  Atul Mehta, University College London
-  Linda Foley, Irish Cystic Fibrosis Registry (TBC)
-  Industry Representative, TBI
èGovernance rules: How to access and publish the data? What are the rules to protect the data and patient privacy?  How to ensure sustainability?

16.00 - Debate & identification of concrete recommendations

16.30 -  Conclusions
Ségolène Aymé, INSERM / Orphanet

16.45 - End Day 2