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         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation

Directory of Study Group 2 Members

SG2 members are listed alphabetically by last name. Corrections should be forwarded to larry.kroger@med.ge.com

Antunes, Miguel, Director, Healthcare Products Vigilance Department, INFARMED, Parque de Saúde de Lisboa, Av. do Brasil, 53, Pav. 17A, 1749-004 LISBOA, PORTUGAL, PH: +351 21 798 7179, FX: +351 21 798 7367, EM: miguel.antunes@infarmed.pt [INFARMED]

Arima, Takehiko, Senior Director Vigilance/Safety & Quality Assurance Division, Medical Company, Johnson & Johnson KK, 5-2 Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo 101-0065, JP. PH: +81 3 4411-7158, FX: +81 3 4411-7159, EM: tarima@jjmkk.jnj.com [JFMDA]

Auclair, Philippe, Director, Regulatory Affairs, Quality and Compliance , Abbott Vascular International BVBA , Park Lane, Culliganlaan 2B, 1831 Diegem, BE. PH: +32 2 7141460, FX: +32 2 7141414, EM: philippe.auclair@av.abbott.com [EUCOMED]

Brady, Mary, Deputy Director, Division of Surveillance Systems, OSB/ CDRH/FDA, HFZ-530, 1350 Piccard Drive, Rockville, Maryland 20850, US. PH: +1 240-276-3458, FX: +1 240-276-3501, EM: Mary.Brady@fda.hhs.gov [FDA]

Demade, Isabelle, Principal Administrator, European Commission, DG Enterprise and Industry, Unit F3 Cosmetics and Medical Devices, Avenue d’Auderghem 45, B-1049 Brussels, BELGIUM, PH: +32 2 295 10 75, FX: +32 2 296 6467, EM: isabelle.demade@ec.europa.eu

Garcia, Jorge, Manager, Medical Device Laboratory Programs, Therapeutic Goods Administration, POBox 100, Woden ACT 2606, Australia, Narrabundah Lane, Symonston, ACT 2609, AU. PH: +61 2 6232 8432, FX: +61 2 6232 8555, EM: jorge.garcia@tga.gov.au [TGA]

Ishikawa, Hiroshi, Assistant to President, Toshiba Medical Systems Co., 26-5 Hongo 3-Chome, Bunkyou-Ku, Tokyo 113-8456, Japan PH: 81-3-3818-2075, FX: 81-3-3814-6170, EM: hiroshi4.ishikawa@toshiba.co.jp [JFMDA]

Khosravi, Ben, Executive Vice President, Technology Program Management, Quality, Leads Business Unit, St. Jude Medical, Cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar, CA 91342, US. PH: +1 818-493-2377, FX: +1 818-364-8416, EM: bkhosravi@sjm.com [AdvaMed]

Kroger, Larry, Senior Regulatory Programs Manager, GE Healthcare, 3000 N. Grandview, W-418, Waukesha, WI 53188, US. PH: +1 262-544-3894, FX: +1 262-544-3202, EM: larry.kroger@med.ge.com [MITA/NEMA]

Kusakabe, Tetsuya, Deputy Director, Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki
Chiyoda-ku, Tokyo 100-8916, JP, PH: +81 3-5253-1111 , FX: +81 3-3508-4364,
EM: kusakabe-tetsuya@mhlw.go.jp [MHLW]

Segstro, Mark, Senior Evaluation Officer, Medical Devices Compliance Unit, Compliance and Enforcement Coordination Division, Health Products and Food Branch Inspectorate, Health Products and Food Branch, Health Canada, 250 Lanark Avenue, Graham Spry Building, 3rd Floor, Address Locator: 2003D, Ottawa, Ontario, Canada, K1A 0K9, PH: +1 613-952-8759 , FX: +1 613-954-0941, EM: mark_segstro@hc-sc.gc.ca [Health Canada]

Stitz, Klaus, Head of Regulatory Affairs, MEDEC - Canada's Medical Device Technology Companies, 405 The West Mall, Suite 900, Toronto, ON M9C 5J1, PH: +1.416.620.1915 x 224, FX: +1.416.620.1595, EM: kstitz@medec.org [MEDEC]

Stösslein, Ekkehard, Head of the Division-Active Medical Devices, Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger Allee 3, D 53175 Bonn, DE. PH: +49-228-207-5384, FX: +49-228-207-5300, EM: e.stoesslein@bfarm.de [BfArM]

Tanakasemsub, Chadaporn (Miang), Regional Regulatory Affairs Director, Asia Pacific, Bausch & Lomb (HK) Ltd., 15/F, One Kowloon, 1 Wang Yuen Street, Kowloon Bay, Hong Kong. AHWP liaison to SG2. PH: 852-2213-3178, FX: 852-2213-3678, EM: miang.tanakasemsub@bausch.com [AHWP]

Tanishiro, Hiroyuki, Chief, Office of Safety, Medical Device Division, Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Bldg.3-3-2 Chiyoda-ku, Tokyo 100-0013, JP. PH: +81- 3-3506-9030, FX: +81- 3-3506-9543, EM: tanishiro-hiroyuki@pmda.go.jp [PMDA]

Wallroth, Carl, General Manager, International Standards and Regulatory Compliance, Medical Division, Drager Medical AG & Co, Moislinger Allee 53/55, 23542 Lübeck, DE. PH: +49-451-882-2267, FX: +49-451-882-4596, EM: beate.moeller@draeger.com [EUROM VI]

Updated 21 February 2008