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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > About GHTF > Steering Committee > GHTF Steering Committee Membership List |
GHTF Steering Committee Membership List
Dr. Kazunari Asanuma (Chair)
Director
Office of Medical Devices Evaluation
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki
Chiyoda-ku
Tokyo 100-8916
Japan Tel: +81 3 3595 2419
Fax: +81 3 3597 0332
email: GHTF-chair@mhlw.go.jp
Dr. Atsushi Tamura
International Coordination Officer for Medical Devices,
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building
3-3-2 Kasumigaseki
Chiyoda-ku
Tokyo 100-0013
Japan
Tel: +81 3 3506 9456
Fax: +81 3 3506 9572
e-mail: tamura-atsushi@pmda.go.jp
Mr. Kentaro Azuma
Deputy Director
Office of Medical Devices Evaluation
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki
Chiyoda-ku
Tokyo 100-8916
Tel: +81 3 3595 2419
Fax: +81 3 3597 0332
email: azuma-kentarou@mhlw.go.jp
Kazuo Ogino (Vice Chair)
Chairman & CEO
NIHON KOHDEN CORPORATION
14-20 Higashi Nakano 3-chome,
Nakano-ku Tokyo 164-0003
Japan
Tel: +81-3-5996-8001
Fax:+81-3-5996-8080
e-mail: Kazuo_Ogino@nkc.co.jp
Shigetaka Miura
Senior Advisor
Sakura Seiki Co., Ltd.
3-1-9 Nihonbashi,
Honcho,
Chuo-ku, Tokyo 103-0023
Tel: 81-3-3270-1666
Fax: 81-3-3510-7519
e-mail: s.miura@sakurajp.com
Mr. Tomomichi Nakazaki
Director
Medical Devices Regulatory Affairs
Allergan Japan K.K.
9-7-1 Akasaka, Minato-ku, Tokyo
107-6207
Japan
Tel: +81-3-6439-2634
Fax: +81-3-6439-2601
e-mail: t-nakazaki@basil.ocn.ne.jp
Dr. Larry Kelly
Coordinator, Monitoring & Compliance Group
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston
ACT 2609
AUSTRALIA
Tel: +61 2 6232 8700
Fax: +61 2 6232 8687
e-mail: larry.kelly@tga.gov.au
Ms Andrea Kunca
Head, Office of Devices Authorisations
Market Authorisation Group
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
AUSTRALIA
Tel: +61 2 6232 8793
Fax: +61 2 6232 8785
e-mail: andrea.kunca@tga.gov.au
Anne Trimmer
Chief Executive Officer
Medical Technology Association of Australia
Level 12, 54 Miller Street
North Sydney NSW 2060
AUSTRALIA
Tel: +61 (0) 2 9900 0650
Fax: +61 (0) 2 9900 0655
e-mail: anne.trimmer@mtaa.org.au
Don Boyer
Acting Director
Medical Devices Bureau
Therapeutic Products Directorate
Health Products and Foods Branch
Health Canada
Tel: 613-957-4786
e-mail: don.boyer@hc-sc.gc.ca
Brian Lewis
President and CEO
MEDEC
405 The West Mall, Suite 900
Toronto, Ontario M9C 5J1
CANADA
Tel: +1 416 641 2750
e-mail: blewis@medec.org
Kimberly A. Trautman MSc
Acting Associate Director, International Affairs
Medical Device International Quality Systems Expert
Center for Devices and Radiological Health (CDRH)
US Food and Drug Administration
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
Dr. Michelle Limoli
Director, Harmonization and Multilateral Affairs Office
Office of International Programs
Food and Drug Administration
10903 New Hampshire Avenue
Building 1, Room 3506
Silver Spring, MD 20903
UNITED STATES
Tel: +1 301 796 8377
Fax: +1 301 847 8612
e-mail: michelle.limoli@fda.hhs.gov
Ms. Janet E. Trunzo
Executive Vice President
Technology and Regulatory Affairs
Advanced Medical Technology Association (AdvaMed)
701 Pennsylvania Ave., NW
Suite 800
Washington DC 20004-2654
UNITED STATES
Tel: +1 202 434 7228
Fax: +1 202 783 8750
e-mail: jtrunzo@advamed.org
Terrence J. Sweeney
Sr. Vice President Corporate Quality and Regulatory Affairs
Philips Healthcare
22100 Bothell Everett Highway
Bothell, WA 98041-3003
UNITED STATES
Tel: +1 425-487-7602
Fax: +1 425-487-8666
e-mail: terry.sweeney@philips.com
Mr. Michael Gropp
Vice President
Global Regulatory Strategy
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
Tel: +1-763-505-3053
Fax: + 1-763-505-2630
e-mail: michael.b.gropp@medtronic.com
Laurent Sellès
Deputy Head of Unit
Cosmetics and Medical Devices
European Commission
DG Health Consumers
BREY 10/177
B-1049 Brussels
BELGIUM
Tel: +32 2 296 34 20
Fax: +32 2 296 64 67
e-mail: laurent.selles@ec.europa.eu
Dr Matthias Neumann
Senior Executive
Medical Devices Safety Unit
Federal Ministry of Health
Friedrichstr 108
7055 Berlin
GERMANY
Tel: +49 30 18441-2636
Fax: +49 30 18441 4838
e-mail: Matthias.neumann@bmg.bund.de
Jean-Claude GHISLAIN
Directeur DEDIM
AFSSAPS (French Agency)
Tél : +33(1)55873745
Fax: +33(1)55873742
e-mail: jean-claude.ghislain@afssaps.sante.fr
Joanna Kilkowska
The Office for Registration of Medicinal Products
Medical Devices and Biocidal Products
Vice-President
Zabkowska Str 41
PL-03-736,
Warsaw, POLAND
Tel: +48 22 492 11 05
Fax: +48 22 492 11 99
e-mail: joanna.kilkowska@urpl.gov.pl
Nicole Denjoy
Secretary General
COCIR
Diamant Building
80 Bd. A Reyers B-1030
BRUSSELS
Tel: +32 (0) 2 706 89 61
Fax: +32 (0) 2 706 89 69
e-mail: denjoy@cocir.org
Jean-Yves Carentz
Vice President RA International
Stryker
ESPACES ANTIPOLIS
300, Route des Cretes - BP116
06902 Sophia Antipolis Cedex
France
Phone: +33 (0) 4 93 00 60 41
Fax: +33 (0) 4 93 00 60 49
e-mail: jeanyves.carentz@stryker.com
Benny Ons
Director Regulatory Affairs,
Compliance and Quality Management BD Europe / EDMA
Erembodegem - DORP 86
B-9320 Erembodegem BELGIUM
Tel +32 53 72 04 02
Fax +32 53 72 04 50
e-mail: Benny_ONS@europe.bd.com
Dr Francois Simondet
Air Liquide Saute International/EUROM VI
28 rue d’Arcueil
94250 Gentilly
FRANCE
Tel. +33 1 49698239
Fax. +33 1 49698289
email: francois.simondet@airliquide.com
Madoka Murakami
Office of International Programs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building
3-3-2 Kasumigaseki
Chiyoda-ku
Tokyo 100-0013
Japan
Tel: +81 3 3506 9456
Fax: +81 3 3506 9572
Email: GHTF.secretariat@pmda.go.jp
Updated 13 April 2012
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