1992 -

Working Towards Harmonization
in Medical Device Regulation

GHTF > About GHTF > Steering Committee > GHTF Steering Committee Membership List

GHTF Steering Committee Membership List

North America

United States - Government:

Dr. Larry Kessler, Sc.D. (Chair)
Director, Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.,
Building 62, Room 3214
Silver Spring
MD 20993-002
UNITED STATES
Tel: +1 301 796-2530
Fax: +1 301 796-9959
e-mail: GHTFChair@fda.hhs.gov

Mr. Timothy Ulatowski
Director, Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
2094 Gaither Rd. , HFZ-300
Rockville
MD 20850
UNITED STATES
Tel: +1 240-276-0100
Fax: +1 240-276-0101
e-mail: timothy.ulatowski@fda.hhs.gov

Ms. Gail Costello
Director, New England District
Acting 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

Mr. David P. Kelly
Associate Director for Harmonization, Europe, Trade
Office of International Programs
Food and Drug Administration
5600 Fishers Lane HFG-1
Rockville
MD 20857
UNITED STATES
Tel: +1 301 827 4480
Fax: +1 301 480 0716
e-mail: DavidP.Kelly@fda.hhs.gov

United States - Industry

Ms. Janet E. Trunzo (Vice Chair)
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 Medical Systems
22100 Bothell Everett Highway
Bothell, WA 98041-3003
Tel: +1 425-487-7602
Fax: +1 425-487-8666
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

Canada - Government:

Dr. Roland Rotter
Director - Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 - Statistics Canada Main Building #3
Postal Locator 0301HI, Tunneys Pasture
Ottawa Ontario K1A 0L2
CANADA
Tel: +1 613 957 4786
Fax: +1 613 957 7318
e-mail: roland_rotter@hc-sc.gc.ca

Canada - Industry:

Stephen Dibert
President and CEO
MEDEC
405 The West Mall, Suite 900
Toronto, Ontario
Canada M9C 5J1
Tel: +1 416 620 1915
e-mail: sdibert@medec.org

Asia-Pacific

Japan - Government:

Ms. Tomiko Tawaragi
Director,
Office of Medical Devices Evaluation
Evaluation and Licensing Division
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
e-mail: tawaragi-tomiko@mhlw.go.jp

Mr. Hiroshi Yaginuma
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: yaginuma-hiroshi@mhlw.go.jp

Japan - Industry:

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
3-26-5 Hongo
Bunkyo-ku
Tokyo 113-8456
JAPAN
Tel: +81 3 3818 2075
Fax: +81 3 3814 6170
e-mail: hiroshi4.ishikawa@toshiba.co.jp

Australia - Government:

Ms. Rita Maclachlan
Director
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: rita.maclachlan@tga.gov.au

Dr. Rohan Hammett
National Manager
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston
ACT 2609
AUSTRALIA
Tel: +61 2 6232 8210
Fax: +61 2 6232 8272
e-mail: Rohan.Hammett@tga.gov.au

Australia - Industry:

Anne Trimmer
Chief Executive Officer
Medical Industry 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@miaa.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.au

European Union

European Commission:

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

European Member States:

Mathias 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 – 0-144 ROMA
Tel: +39 06 5994 3809
Fax: +39 06 5994 3380
email: g.ruocco@sanita.it

Jos Kraus
Health Care Inspectorate
P.O. Box 5837
2280 HV Ryswyk
The Netherlands
Tel: +31 70 372 3165
Fax: +31 70 372 3110
e-mail: 1) medtech.higz@igz.nl and 2) j.kraus@igz.nl

Europe - Industry:

Dr Brian R Matthews
Senior Director, EC Registration / Authorised Representative
Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Hertfordshire
HP2 7UD
United Kingdom
Tel: +44 1442 341 176
Fax: +44 1442 341 280
e-mail: Brian.Matthews@alconlabs.com or LT09@dial.pipex.com

Ms. Christine Tarrajat
Director General EDMA
Place des Maieurs, 2
1150 Brussels
BELGIUM
Tel: +32 2 777 0271
Mob: +32 4 754 64182
Fax: +32 4 754 64182
e-mail: c.tarrajat@edma-ivd.be

Mr. Werner Schoenbuehler
COCIR - European Coordination Committee of the Radiological,
Electromedical and Healthcare IT Industries
c/o Siemens AG, Medical Solutions
Quality Management & Regulatory Affairs
Henkestr. 127
91052 Erlangen
GERMANY
Tel: +49 (0) 9131 84-8442
Fax: +49 (0) 9131 84-6555
e-mail: werner.schoenbuehler@siemens.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

Study Group Chairs

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: +1 240-276-3744
Fax: +1 240-276-3789
e-mail: ginette.michaud@fda.hhs.gov

Dr. Jorge Garcia
Manager, Medical Device Laboratory Programs,
TGA Laboratories
136 Narrabondah Lane
Symonston, ACT 2606
ACT AUSTRALIA
PH: +61 2 6232 8432,
FX: +61 2 6232 8555,
e-mail : jorge.garcia@tga.gov.au [TGA]

Mr. Egan Cobbold
Quality Systems Officer
Medical Devices Bureau
Health Canada
Rm 1605, Main Statistics Bldg., PL 0301H1
Tunney's Pasture
Ottawa, Ontario
K1A 0L2
CANADA
Tel: 1 613 954 4597
Fax: 1 613 954 7666
e-mail: Egan_Cobbold@hc-sc.gc.ca

Markus Zobrist, PhD
Swissmedic
Division of Medical Devices
Hallerstasse 7
P.O. Box
CH-3000 Berne 9
Switzerland
Tel: +41 31 324 9181
Fax: + 41 31 322 7646
e-mail: markus.zobrist@swissmedic.ch

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

Secretariat

Jean Olson
Program Analyst
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Blvd. (HFZ-84)
Rockville
MD 20850
UNITED STATES
Fax: +1 240-276-8717
Fax: +1-240-276-8713
e-mail: jean.olson@fda.hhs.gov

Updated 14 March 2008

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