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in Medical Device Regulation
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| GHTF > Study Groups > Study Group 3 (SG3) > Directory of Study Group 3 Members |
Egan Cobbold MSc, Chairman
Health Canada
Quality Systems Officer
Medical Devices Bureau
150 Tunney’s Pasture Driveway , Room 2605
Tunney's Pasture, PL 0301H1
Ottawa, Ontario, K1A 0K9, CANADA
Tel: 1-613-954-4597
Fax: 1-613-946-6758
E-mail: Egan_Cobbold@hc-sc.gc.ca
Carlos Arglebe, Vice-Chairman
Coordination Committee of the
Radiological, Electromedical and
Healthcare IT Industry (COCIR)
Bvd A. Reyers 80,
1030 Brussels, BELGIUM
Tel: +32 (0)2 706 8960
Fax: +32 (0)2 706 8969
E-mail: carlos.arglebe@siemens.com
Laila Gurney M.Sc., RAC
MEDEC
c/o GE Healthcare
Director, Regulatory Affairs (Canada)
2300 Meadowvale Blvd
Mississauga, ON, L5N 5P9, CANADA
Tel: +1 905-567-3748
Fax: +1 905-567-2115
E-mail: laila.gurney@ge.com
Keith M Smith
Therapeutic Goods Administration
Quality System Manager
Office of Manufacturing Quality
Therapeutic Goods Administration
Symonston, ACT 2609, AUSTRALIA
Tel: +61 (0) 2 6232 8316
Fax: +61 (0) 2 6232 8426
E-mail: keith.m.smith@tga.gov.au
Ken Nicol PhD
Medical Technology Association of Australia (MTAA)
St. Jude Medical Australia Pty. Ltd.
Director, Regulatory
Asia Pacific
17 Orion Road
Lane Cove, NSW 2066, AUSTRALIA
Tel +61 2 9936 1290
Fax +61 2 9936 1222
Mobile +61 (0) 414 346 111
E-mail: knicol@sjm.com
Hironori Matsumoto
Ministry of Health, Labour and Welfare
Compliance and Narcotics Division Pharmaceutical and Food Safety Bureau
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-8916, JAPAN
Tel: +81-3-5252-1111 (ext 2770)
Fax: +81-3-3506-9466
E-mail: matsumoto-hironori@mhlw.go.jp
Kenichi Ishibashi
Pharmaceuticals and Medical Devices Agency (PMDA)
Office of GMP/QMS Inspection
Shin-Kasumigaseki Building 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, JAPAN
TEL:+81-3-3506-9446
FAX:+81-3-3506-9465
E-mail: ishibashi-kenichi@pmda.go.jp
Akie Yamashita
Pharmaceuticals and Medical Devices Agency (PMDA)
Office of GMP/QMS Inspection
Shin-Kasumigaseki Building 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, JAPAN
TEL:+81-3-3506-9446
FAX:+81-3-3506-9465
E-mail: yamashita-akie@pmda.go.jp
Hideki Asai
The Japan Federation of Medical Device Associations (JFMDA)
c/o Hitachi High-Technologies Corporation
Nanotechnology Products Business Group
Naka Division, Medical System Center
882, Ichige, Hitachinaka
Ibaraki, 312-8504, JAPAN
Tel: +81-29-354-5958
Fax: +81-29-275-1163
E-mail: asai-hideki@naka.hitachi-hitec.com
Munehiro Nakamura
The Japan Federation of Medical Device Associations (JFMDA)
c/o Kaneka Corporation
Manager, Medical Devices Division
3-2-4, Nakanoshima, Kita-ku,
Osaka, 530-8288, JAPAN
Tel:+81-6-6226-5141
Fax:+81-6-6226-5143
E-mail: Munehiro_Nakamura@kn.kaneka.co.jp
Dr. Rainer Edelhaeuser
Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten (ZLG)
Central Authority of the Laender for Health Protection
with Regard to Medicinal Products and Medical Devices
Sebastianstrasse 189
53115 Bonn, Germany
Tel.: +49 228 97794 12
Fax: +49 228 97794 44
E-Mail: rainer.edelhaeuser@zlg.nrw.de
Emmett Devereux
European Medical Device Industry Group (Eucomed)
c/o Cook Medical
Quality Management, Clinical & Regulatory Affairs
National Technology Park
O’Halloran Road,
Limerick, IRELAND
Tel: +353 61 334440
Fax: +353 61 334441
E-mail: edevereux@cook.ie
Laila Gurney M.Sc., RAC
MEDEC
c/o GE Healthcare
Director, Regulatory Affairs (Canada)
2300 Meadowvale Blvd
Mississauga, ON, L5N 5P9, CANADA
Tel: +1 905-567-3748
Fax: +1 905-567-2115
E-mail: laila.gurney@ge.com
Kimberly Trautman MSc
US Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Acting Associate Director, International Affairs
Medical Device International Quality Systems Expert
WO 66-3422
10903 New Hampshire Avenue
Silver Spring , MD 20993-0002, USA
Tel: +1 301-796-5515
E-mail: kimberly.trautman@fda.hhs.gov
Scott S. Sardeson
AdvaMed
c/o 3M Health Care
International Regulatory Affairs Manager
3M Center 275-5W-06
St. Paul , MN 55144-1000, USA
Tel: 1 651 736 2025
Fax: 1 651 737 5320
E-mail: ssardeson@mmm.com
Gunter Frey
National Electrical Manufacturers Association
c/o Philips Healthcare
3000 Minuteman Road
Andover, MA 01810, UNITED STATES
Tel.: 1-919-650-2096
Fax: 1-919-650-2096
E-mail: gunter.frey@philips.com
Ee Bin Liew
Asian Harmonization Working Party
AHWP Co-Chair AHWP-WG3
Philips Healthcare
Director, Quality & Regulatory, Cluster Asia Pacific
Philips Electronics Singapore Pte Ltd
TP3 Level 2, 620A Lorong 1 Toa Payoh
Singapore 319762
Direct line: +65 68825480
Fax: + 65 62562502
Email: liew.ee.bin@philips.com
Updated 28 November 2011
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