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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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| GHTF > Study Groups > Study Group 1 (SG1) > Directory of IVD Subgroup Participants |
Benny Ons, Chairman
BD Biosciences
Director Regulatory Affairs and Quality Management
POB 13, Denderstraat 24
B-9320 Erembodegem, BELGIUM
Tel: +32 53 72 04 02
Fax: +32 53 72 04 50
e-mail: Benny_ONS@europe.bd.com
Shelley Tang
Therapeutic Goods Administration
A/g Head
Office of Devices Authorisation
136 Narrbundah Lane
Symonston ACT 2609
AUSTRALIA
Tel: +61 2 6232 8793
Fax: +61 2 6232 8785
e-mail: Shelley.Tang@tga.gov.au
Jilianne Coles
Alere
Regulatory Affairs Manager
532 Seventeen Mile Rocks Rd
Sinnamon Park, QLD
AUSTRALIA, 4073
Tel: + 61 7 3363 7100
Fax: + 61 7 3363 7199
Email: jillianne.coles@alere.com
Dr. Daisei Miyamoto
Pharmaceuticals and Medical Devices Agency (PMDA)
Deputy Review Director, Office of Medical Devices II
Shin-Kasumigaseki Bldg
3-3-2, Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 JAPAN
Tel: +81-3-3506-9468
Fax: +81-3-3506-9474
email: miyamoto-daisei@pmda.go.jp
Kazutoshi Yamagishi
Japan Analytic Instruments Manufacturer’s Association (JAIMA) 3
C/O Toshiba Medical Systems Corporation
Chief Specialist, Development & Engineering Group
Clinical Laboratory Systems Division
Tel: +81 287 26 6202
Fax : +81 287 26 6054
e-mail: kazutoshi.yamagishi@toshiba.co.jp
Yoko Ikeda
Japan Association of Clinical Reagents Industries (JACRI)
c/o Nippon Becton Dickinson Company Ltd
Senior Manager, Regulatory Affairs
2-15-1, Akasaka, Minato-ku
Tokyo 107-0052 JAPAN
Tel: +81-3-6234-5450
Fax: +81-3-6234-5585
email:yoko_ikeda@bd.com
Marie-Lise Migueres
AFSSAPS/DEDIM
Adjointe au Directeu r en charge des Affaires Européennes et Internationales
143-147 Boulevard Anatole France
93285 Saint-Denis cedex
France
Tel : +33 1 55 87 36 85
Fax : +33 1 55 87 37 42
Email : Marie-Lise.MIGUERES@afssaps.cante.fr
Céline BOURGUIGNON
European Commission - Directorate General Enterprise and Industry
Unit F3 - Cosmetics and Medical Devices
Street address : Avenue d'Auderghem 45, B-1040 Brussels
Postal address : BREY 10/165, B-1049 Bruxelles
Tel : +32 22 95 91 10
E-mail : Celine.BOURGUIGNON@ec.europa.eu
Dr. Michael Thein
EDMA European Diagnostics Manufacturers Association
c/o Roche Diagnositcs GmbH
Head of QM & Reg. Affairs Roche Centralized Diagnostics
LQ, Building 161
D-68305 Mannheim
Tel: +49 62 1759 8436
Fax: +49 62 1759 6327
e-mail: michael.thein@roche.com
Dr. Petra Kaars-Wiele
EDMA European Diagnostics Manufacturers Asociation
c/o Abbott GmbH & Co. KG
Diecotr Regulatory Affairs/Affiliate Compliance
GERMANY
Tel: +49 6122 581239
Fax: +49 6122 582128
e-mail: petra.kaars-wiele@abbott.com
Ms. Maria Carballo
Health Canada
Medical Devices Bureau
Room 1605, Main Statistics Building
Tunney's Pasture, PL# 0301H1
Ottawa , Ontario, K1A 0L2, CANADA
Tel: +1 613 954 9391
Fax: +1 613 957 7318
e-mail: maria_carballo@hc-sc.gc.ca
Mr. Matthew Gee
MEDEC Canada
c/o SIEMENS Healthcare Diagnostics Ltd., 1200 Courtney Park Drive East
Toronto, Ontario L5T 1P2, CANADA
Tel: +1 905 743 1655 Ext. 4539
e-mail: Matthew.Gee@siemens.com
Dr. Francis Kalush
US Food and Drug Administration
Network Leader, Diagnostics and Personalized Medicine
Office of the Center Director/ CDRH
7520 Standish PL., MPN1, HFZ-4,
Rockville, MD 20855, UNITED STATES
Tel: +1 240 276 8850
Fax: +1 240 276 8855
e-mail: Francis.Kalush@fda.hhs.gov
Andrea J. Casper
AdvaMed, USA
Vice President, Worldwide Regulatory Affairs
Ortho-Clinical Diagnostics, Inc.
1001 US Highway 202
Raritan, NJ 08876, USA
Tel: +1 908.218.8177
Fax: + 1 908 218 8178
email: acasper1@ocdus.jnj.com
Regina J. O’Meara *
Director, Global Legislative & Government Affairs
Beckman Coulter, Inc.
Brea , CA 92822 USA
Tel: +1 714 993 8383
Fax: +1 714 961 4234
Email: rjomeara@beckman.com
{* = Alternate}
Essam Mohammed Y. Al-Mohandis
Saudi Food & Drug Authority
Chief Biomedical Engineer
Medical Devices Sector
3292 North Ring Road,
Alnafel Unit (1), Riyadh, Saudi Arabia
Tel: (966) 1 2759222 Ext.422
Fax: (966) 1 2757245
Email: EMMohandia@sfda.gov.sa
Jeffrey Chern
Industial Technology Research Institute
Medical Device Evaluation Engineer,
Office of Medical Device Evaluation
Room. 300, Bldg. 16, 321, Sec.2, Kuang Fu Rd, Hsinchu, Taiwan 300, R.O.C.
Tel: (886) 3 5743730
Fax: (886) 3 5734092
Email: JFChern@itri.org.tw
Updated 16 November 2011
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