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Tuesday 29 November, 2005
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1300
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Lunch
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1400
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Welcome from the Chair
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Hendrik
Emons
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Tour de table
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1410 -1530
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EU Regulatory issues regarding
RMs for Genetic testing
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Hendrik
Emons & Philippe Corbisier
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1410
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Implementation of the IVD
Directive in Genetic Testing
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John
Brennan
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1430
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ISO Standardization of Clinical
laboratory testing and in vitro diagnostic test systems (point of
view)
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Klaus
Stinshoff
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1510
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Discussion
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1530
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Coffee
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1600
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Patent issues
in RMs for Genetic Testing
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Pierre
Kihn
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1620
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Open Discussions
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Patents and RM Production
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Forming an EU working group on RMs
for genetic testing
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Wednesday
30 November, 2005, IRMM
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0900
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Welcome
and introductions
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David
Barton
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0910
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Definitions
of Types of Reference Materials and Controls
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Philippe
Corbisier
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0920-1100
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Needs
of Stakeholders for Reference Materials for Genetic Testing
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0920
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European
Genetic Testing Labs
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Christine
Brady
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0930
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Coriell
market surveys
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Jeanne
Beck
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Short
statements from Industry and Regulators:
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0945
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Innogenetics
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Gonda
Verpooten
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0955
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Roche
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Hubertus
Stockinger
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1005
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Applera
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Michael
Zoccoli
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1015
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Qiagen
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Edgar
Setzke
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1025
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Affymetrix/IMCLGS
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Janet
Warrington
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1040
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ISO
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Klaus
Stinshoff
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1045
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LGC
(UK)
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Helen
Parkes
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1050
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FDA
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Zivana
Tezak
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1100
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Coffee
Break
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1130-1300
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Current
situation as regards the availability & development of
control materials for genetic testing
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1130
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Availability
of RMs for Genetic Testing in Europe
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David
Gancberg
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1140
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Development
of RMs for Genetic Testing in Europe
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David
Barton
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1200
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NIBSC
Activities in RMs for Genetic Testing
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Elaine
Gray/Paul Metcalfe
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1215
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Development
of GTQC program
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Joe
Boone
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1225
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GTQC
QC materials development
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lisa
Kalman
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1245
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Maine
Molecular Quality Controls : a case study
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Clark
Rundell
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1300
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Lunch
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1400-1530
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Prioritization
of Needs for Reference Materials for Genetic Testing
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1400
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Determining
Needs and Ongoing Monitoring : The US Experience
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Bin
Chen
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1415
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Criteria
for Prioritization : EU Perspective
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David
Barton
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1430
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International
Meeting on Clinical and Laboratory Genomic Standards
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Janet
Warrington
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1445
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Discussion
of priorities for RM production
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1530
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Coffee
Break
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1600
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Open
Discussion/Future plans
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Discussion
topics to include:
- Joint
EU/US effort
- Formation
of a Working Group
- Joint
needs assessment and monitoring
- Interaction
with IMCGLS
- Logistical
issues US/EU
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1650
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Plans
for future EU and International Symposia
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1700
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Close
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