Harmonizing genetic
testing across Europe
|
Event - Workshop on the IVD Directive and Genetic Testing (WP1.6)
|
|
|
|
|
-
When
-
Tuesday 24 April 2007
-
Where
-
3000
Leuven
Belgium 
By Invitation Only
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
|
