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Event - Workshop on the IVD Directive and Genetic Testing (WP1.6)

When

Tuesday 24 April 2007

Where

3000 Leuven
Belgium Flag of Belgium

By Invitation Only

Contact


What

09:30 Welcome and introductions - David Barton, National Centre for Medical Genetics, Dublin
09:40 Introduction to the IVD Directive Download PDF Document - John Brennan, DG Enterprise
10:00 Public Health Perspective I Download PDF Document- Stuart Hogarth, University of Cambridge
10:30 Public Health Perspective II Download PDF Document - Tobias Schulte in den Baeumen, PHGEN
   
11:00 coffee
   
11:20 Comparison of EU and US regulatory frameworks Download PDF Document - Tim Stenzel, Abbott
11:35 Industry perspective Download PDF Document - Karen Howes, EDMA
11:50 Swiss perspective Download PDF Document - Andreas Schlegel, Swissmedic
   
12:30 Lunch
   
13:30 AFTERNOON DISCUSSION TOPICS
  Exemption for in-house assays:
 
  • - How is it being applied across Europe?
  • - Defining a "health institution"
  The coverage of genetic tests under the IVDD: plans for adding some tests to Annex II and proposed changes to the Medical Devices Directive: Implications for IVDs Exit this website Download PDF Document- John Brennan, DG Enterprise
15:00 coffee
   
  Reference Materials
15:20 CRMs, CE-marked RMs, JCTLM RMs, WHO standards - bringing clarity to the alphabet soup Download PDF Document - David Gancberg JRC-IRMM, Geel
15:30 Coverage of RMs under the IVDD - responses to scenarios sent to DG Enterprise and MHRA Download PDF Document - David Barton, National Centre for Medical Genetics, Dublin
15:45 Progress towards CE marked reference materialsExit this website Download PDF Document - Ross Hawkins & Varsha Patel, NIBSC, London
16:05 Discussion
   
16:30 Summary and next steps - David Barton, National Centre for Medical Genetics, Dublin
   
17:00 Close

 

Confirmed attendance as of 21 May, 2007

Name Organization
David Barton EuroGentest, Dublin
John Brennan DG Enterprise
Patrick Buckley Irish Medicines Board
Mark Dobson SNiP2CHIP STREP
Karl Freese DG Health
David Gancberg JRC-IRMM
Ross Hawkins NIBSC/WHO
Stuart Hogarth University of Cambridge
Karen Howes EDMA
Dolores Ibarreta DG Research
Mike Morris EuroGentest, Geneva
Clemens Mueller EuroGentest, Wuerzburg
Varsha Patel NIBSC/WHO
Valerie Race EuroGentest, Leuven
Jean-Luc Sanne DG Research
Andreas Schlegel Swissmedic
Tobias Schulte in den Baeumen PHGEN Network
Tim Stenzel Abbott Molecular
Evelyn Tait SAFE NoE

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