| What |
| 09:30 |
Welcome and introductions - David Barton, National Centre for Medical Genetics, Dublin |
| 09:40 |
Introduction to the IVD Directive - John Brennan, DG Enterprise |
| 10:00 |
Public Health Perspective I - Stuart Hogarth, University of Cambridge |
| 10:30 |
Public Health Perspective II - Tobias Schulte in den Baeumen, PHGEN |
| |
|
| 11:00 |
coffee |
| |
|
| 11:20 |
Comparison of EU and US regulatory frameworks - Tim Stenzel, Abbott |
| 11:35 |
Industry perspective - Karen Howes, EDMA |
| 11:50 |
Swiss perspective - 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 - 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 - David Gancberg JRC-IRMM, Geel |
| 15:30 |
Coverage of RMs under the IVDD - responses to scenarios sent to DG Enterprise and MHRA - David Barton, National Centre for Medical Genetics, Dublin |
| 15:45 |
Progress towards CE marked reference materials - 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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