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Working Towards Harmonization
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 2 (SG2) > Directory of Study Group 2 Members |
Chair : Demade, Isabelle, Principal Administrator, European Commission, DG Enterprise and Industry
Vice- Chair : Arima, Takehiko, Senior Director Vigilance/Safety & Quality Assurance Division, Medical Company, Johnson & Johnson K.K., Japan
Secretary : Auclair, Philippe, Director Intl, Regulatory Compliance, Quality and Government Affairs, Abbott Vascular International
SG2 members are listed alphabetically by last name within each regional area. Corrections should be forwarded to philippe.auclair@av.abbott.com
Carter, Pamela, Director, Market Vigilance and Monitoring Section, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia, 136 Narrabundah Lane, Symonston ACT 2609, Australia. PH: +61 2 6232 8713, FX: +61 2 6232 8555, EM: pamela.carter@tga.gov.au [TGA]
Matsui, Yutaka, Technical Officer, Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (MHLW), 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, JP, PH: +81 3-3595-2435, FX: +81 3-3508-4364, EM: matsui-yutaka@mhlw.go.jp [MHLW]
Tanishiro, Hiroyuki, Ph.D., Deputy Division Director, Medical Device Division, Office of Safety 1st, Pharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, JP. PH: +81- 3-3506-9030, FX: +81- 3-3506-9543, EM: tanishiro-hiroyuki@pmda.go.jp [PMDA]
Sano, Yoshihiko, Deputy Director, Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare (MHLW), 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, JP, PH: +81 3-3595-2435, FX: +81 3-3508-4364, EM: sano-yoshihiko@mhlw.go.jp [MHLW]
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
Ruiz-Villar, Carmen, Section Head of the Vigilance and Marketing Surveillance of Medical Devices Unit, Spanish Agency for Medicines and Medical Devices (AEMPS), Campezo 1, 28022 Madrid, PH: +34-91-822-5362, FX: +34-91-822-5289, EM: cruizv@agemed.es
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]
Brady, Mary, MSN, RN, Associate Director for International and Home Care Initiatives, 10903 New Hampshire Avenue, Bldg 66, Room 2320, Silver Spring, MD 20993, US. PH: +1 301-796-6089 : Mary.Brady@fda.hhs.gov [FDA]
Harrison, Barbara, Acting Manager, 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: +1 613-954-6666, FX: +1 613-954-0941, EM: barbara.harrison@hc-sc.gc.ca [Health Canada]
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@its.jnj.com [JFMDA]
Ishikawa, Hiroshi, Assistant to President, Toshiba Medical Systems Co., 1385, Shimoishigami, Otawara-Shi, Tochigi,324-8550, Japan .Tel +81-287-26-6774
FAX +81-287-26-6050 EM: hiroshi4.ishikawa@toshiba.co.jp [JFMDA]
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]
Auclair, Philippe, Director Intl, Regulatory Compliance, Quality and Government Affairs, 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]
Wallroth, Carl, General Manager, International Standards and Regulatory Compliance, Medical Division, Drager Medical AG & Co, Moislinger Allee 53/55, 23542 Lübeck, DE., PH: +49-170-85 442 14 FX: +49-451-882-7-4018 EM: beate.moeller@draeger.com [EUROM VI]
Khosravi, Ben, Executive VP ,Product Development & Leads operations, CRM Division. St. Jude Medical 15900 Valley View Court, Sylmar, CA 91342, US. PH: +1 818-493-2377, FX: +1 818-364-8416, EM: bkhosravi@sjm.com [AdvaMed]
Mills, Barbara, Manager, Quality Assurance, GE Healthcare, 3000 N. Grandview Blvd, Waukesha, WI 53188, PH: +1 262 548 4996, FX: +1 262 544 3141, EM: barbara.mills@ge.com [MITA]
Stitz, Klaus, VP Regulatory Affairs, MEDEC - Canada's Medical 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]
Updated 16 September 2009
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