Topic
(Titles shown below are linked to abstracts)
|
Speaker
|
| Introduction and Welcome |
|
| EC IVD Directive - Expectations and
Implications |
Kim Carneiro, Ph.D., Danish Institute of Fundamental Metrology,
Denmark |
| Standardization Activities to Support
the Implementation of the IVD-Directive: Harmonized Standards and the European
Free Market |
Emil Voelkert, Ph.D., Roche Diagnostics, Germany, CEN/TC
140, Chair |
| Status of MRAs and International Standardization |
Hratch G. Semerjian, Ph.D., NIST, USA |
| Process for Credentialing Reference
Materials, Reference Methods, and Reference Laboratories in Europe |
Lothar Siekmann, Ph.D., University of Bonn, Germany |
| European Reference Materials Activities
in the Clinical Field |
Heinz Schimmel, Ph.D., Institute for Reference Materials and
Measurements (IRMM), Belgium |
| The IVD Directive Requirement for
Calibration Traceability: Impact on IVD Manufacturers |
Neil Greenberg, Ph.D., D.A.B.C.C., Ortho Diagnostics, USA |
| History of Reference Systems for Clinical
Measurements |
John H. Eckfeldt, M.D., Ph.D., CAP, University of Minnesota,
USA |
| Development Of Reference Methods and
Reference Materials in the U.S. |
Willie E. May, Ph.D, NIST, USA |
| Importance of Commutable Human Specimens
and Test Value Distributions for Assay Calibration |
George G. Klee., M.D., Ph.D., Mayo Clinic, USA |
| Reference Systems Models from Other
Industries |
Joan Walsh Cassedy, M.B.A., ACIL, (formerly the American Council
of Independent Laboratories), USA |
Invited
Talks