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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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| GHTF > About GHTF > Steering Committee > GHTF Steering Committee Membership List |
Dr. Larry Kelly (Chair)
Head, Office of Devices, Blood and Tissues
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston
ACT 2609
AUSTRALIA
Tel: +61 2 6232 8700
Fax: +61 2 6232 8687
e-mail: ghtf.chair@tga.gov.au
Dr. Rohan Hammett
National Manager
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston
ACT 2609
AUSTRALIA
Tel: +61 2 6232 8200
Fax: +61 2 6232 8272
e-mail: Rohan.Hammett@tga.gov.au
Anne Trimmer (Vice Chair)
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
Mr. Johan Brinch
V.P. Regulatory Affairs
Cochlear Limited
14 Mars Road
Lane Cove, NSW 2066
AUSTRALIA
Tel: +61 2 9428 6560
Fax: +61 2 9428 6539
e-mail: jbrinch@cochlear.com
Dr. Toshiyoshi Tominaga
Director
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: tominaga-toshiyoshi@pmda.go.jp
Mr. Kentaro Azuma
New Medical Material Specialist
Office of Medical Devices Evaluation
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
Tel: +81 3 5253 1111 ext. 2787
Fax: +81 3 3597 0332
email: azuma-kentarou@mhlw.go.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: 81-3-3510-7537
e-mail: s.miura@sakurajp.com
Mr. Hiroshi Ishikawa
Assistant to President
Toshiba Medical Systems Corporation
1385 Shimoishigami Ootawara shi Tochigi
324-855
JAPAN
Tel: +81 287 26 6774
Fax: +81 287 26 6050
e-mail: hiroshi4.ishikawa@toshiba.co.jp
Dr. Roland Rotter
Director - Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
1st Floor, Room 1605, Main Statistics Canada Building
150 Tunney's Pasture Driveway, Tunney's Pasture
Address Locator: 0301H1
Ottawa, Ontario K1A OK9
CANADA
Tel: +1 613 957 4786
Fax: +1 613 957 7318
e-mail : Roland_Rotter@hc-sc.gc.ca
Stephen Dibert
President and CEO
MEDEC
405 The West Mall, Suite 900
Toronto, Ontario M9C 5J1
CANADA
Tel: +1 416 620 1915
e-mail: sdibert@medec.org
Timothy Ulatowski
Director, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
W066-3423
Silver Spring, MD 20993
UNITED STATES
Tel: +1 301-796-5504
Fax: +1 301-847-8136
e-mail: timothy.ulatowski@fda.hhs.gov
Ms. Gail Costello
Regional Food & Drug Director, Northeast
Office of Regulatory Affairs
Food and Drug Administration
One Montvale Avenue, HFR-NE240
Stoneham, MA 02180
UNITED STATES
Tel: + 1 781-596-7758
Fax: +1 781-596-7896
e-mail: gail.costello@fda.hhs.gov
Dr. Michelle Limoli
Director, Harmonization and Multilateral Affairs Office
Office of International Programs
Food and Drug Administration
5600 Fishers Lane HFG-1
Rockville, MD 20857
UNITED STATES
Tel: +1 301 827 0908
Fax: +1 301 827-0003
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 Enterprise and Industry
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
Matthias Neumann
Division 116, Medical Devices
Federal Ministry of Health
Friedrichstr 108
77055 Berlin
GERMANY
Tel: +49 30 18441-2636
Fax: +49 30 18441 4838
e-mail: Matthias.neumann@bmg.bund.de
Giuseppe Ruocco
Ministry of Health - Italy
Via G. Ribotta,
5-00144 ROMA
Tel: +39 06 5994 3241/3207
Fax: +39 06 5994 3376
e-mail: g.ruocco@sanita.it
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 RAQA
Stryker Europe, Middle-East and Africa (Representing EUCOMED)
HQ, Les Espaces de Sophia
80, Route des Lucioles, BP 037
06901 Sophia Antipolis Cedex
FRANCE
Tel: +33 (0) 4 92 95 25 28
Fax: +33 (0) 4 92 95 25 29
e-mail: jeanyves.carentz@stryker.com
Benny Ons, Vice-Chairman
BD Europe/ EDMA
Director Regulatory Affairs and Quality Management
POB 13, 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. Carl F Wallroth
General Manager
International Standards and Regulatory Compliance, Medical Division
Dräger and P EUROM VI Medical Technology
Dräger Medical AG & Co. KGaA
Moislinger Allee 53/55 23542
Lübeck
GERMANY
Tel: +49 451 882 2267
Mob: +49 170 854 4214
Fax: +49 451 882 4596
e-mail: beate.moeller@draeger.com
Ginette Michaud, M.D.
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Blvd., HFZ-480
Rockville, MD 20850
UNITED STATES
Tel: +1 240 276 3700
Fax: +1 240 276 3789
e-mail: ginette.michaud@fda.hhs.gov
Isabelle Demade
Principal Administrator
European Commission
DG Enterprise and Industry
Unit F3 Cosmetics and Medical Devices
Avenue d'Auderghem 45
B-1049 Brussels, BELGIUM
Tel: +32 2 295 10 75
Fax: +32 2 296 6467
e-mail: isabelle.demade@ec.europa.eu
Mr. Egan Cobbold
Quality Systems Officer
Medical Devices Bureau
Health Canada
Rm 1605, Main Statistics Bldg.,
Tunney's Pasture PL 0301H1
Ottawa, Ontario
K1A 0L2 CANADA
Tel: 1 613 954 4597
Fax: 1 613 954 7666
e-mail: Egan_Cobbold@hc-sc.gc.ca
Ms. Jan Welch
Food and Drug Administration
Center for Devices and Radiological Health
2094 Gaither Road , HFZ-320
Rockville , MD 20850
UNITED STATES
Tel: 1-240-276-0354
Fax: 1-240-276-0114
e-mail: jan.welch@fda.hhs.gov
Dr. Susanne Ludgate
Clinical Director, Devices
BSc MB ChB DMRT FRCR FRACR
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: +44 020 7084 3123
Fax: +44 020 7084 3111
Mob: 07990 531 729
e-mail: Susanne.Ludgate@mhra.gsi.gov.uk
Linda Martin
Parliamentary and Management Group
Office of Devices, Blood and Tissues
Therapeutic Goods Administration
Australia
Street address:
136 Narrabundah Lane
SYMONSTON ACT 2609
Postal address:
PO Box 100
WODEN ACT 2606
AUSTRALIA
Tel: +61 2 6232 8726
Fax: +61 2 6232 8687
Email: ghtf.secretariat@tga.gov.au
Susan K. Meadows
Secretariat, U.S. Delegation GHTF
Food and Drug Administration (FDA)
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO #66, Room 5426
Silver Spring, MD 20993
Phone: 301-796-6672
Fax: 301-847-8510
e-mail: susan.meadows@fda.hhs.gov
Updated 4 February 2010
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