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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 > Study Groups > Study Group 2 (SG2) > Directory of Study Group 2 Members |
Vice- Chair : Arima, Takehiko, Senior Director Vigilance/Safety & Quality Assurance Division, Medical Company, Johnson & Johnson
Secretary : Auclair, Philippe, Senior Director, Regulatory Strategy and Advocacy , Abbott Quality and Regulatory EMEA, Abbott Vascular International
SG2 members are listed alphabetically by last name within each regional area. Corrections should be forwarded to philippe.auclair@abbott.com
Carter, Pamela, Director, Device Vigilance and Monitoring , Office of Product Review , 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]
Tanaka Daisuke, R Ph, Ph.D. Deputy Director, Safety Division, Pharmaceutical and Food Sanitation Bureau Ministry of Health, Labour and Welfare (MHLW) 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, JAPAN PH: +81-3-3595-2435 FX: +81-3-3508-4364 EM: tanaka-daisuketd@mhlw.go.jp [MHLW]
Tanishiro , Hiroyuki, Ph.D, Chief, Office of Safety, Medical Device Division, 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]
Essam Mohammed AlMohandis , Biomedical Engineer Director of Surveillance and Biometrics Medical Devices Sector Saudi Food and Drug Authority, 3292 Northern ring RD.Riyadh 13312-6288 Kingdom of Saudi Arabia PH: +966 1 2759222 ext.1422 FX: +966 1 2751164 EM: emmohandis@sfda.gov.sa. [AHWP]
Demade, Isabelle, Principal Administrator, European Commission, DG Health and Consumers, Unit B2, 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@aemps.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: ekkehard.stoesslein@bfarm.de [BfArM]
Brady, Mary, MSN, RN Senior Policy Analyst U.S. Food and Drug Administration Center for Devices and Radiological Health10903 New Hampshire Avenue Bldg 66-2320 Silver Spring, MD 20993 US. PH:+1 301-796 6089 -FX: XXXX, EM: Mary.Brady@fda.hhs.gov [FDA]
Rose, Chris, Manager, Medical Device Compliance Unit, Compliance and Enforcement Coordination Division, Health Products and Food Branch Inspectorate, 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: christopher.rose@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., 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]
Tanakasemsub, Chadaporn (Miang), QA/RA director, Asia Pacific Zimmer Medical (Thailand) Co.,Ltd. 183 Rajanakarn Building, 2nd floor, South Sathorn Road, Yannawa, Sathorn, Bangkok 10120 PH: +66 2638 1942 (direct line) FX: +66 2676 8902 EM: miang.tanakasemsub@zimmer.com [AHWP]
Auclair, Philippe, Senior Director, Regulatory Strategy and Advocacy , Abbott Quality and Regulatory EMEA, Abbott Vascular International BVBA , Park Lane, Culliganlaan 2B, 1831 Diegem, BE. PH: +32 2 7141460, FX: +32 2 7141414, EM: philippe.auclair@abbott.com [EUCOMED]
König , Bertram Eduard Wilhelm, Vice President Operations & Quality, Divison Quality Management and Operations, B. Braun Avitum AG, Stadtwaldpark - Haus 1, 34212 Melsungen, DE. PH: +49 5661 71 3793, FX: +49 5661 75 3793, EM: bertram.koenig@bbraun.com [EUROM IV]Mills, Barbara, Manager, Quality Operations, 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]
Santalucia, Michael Vice President Global RA - Vision Care Bausch + Lomb Rochester, 1400 N. Goodman St, Rochester, NY 14609 PH:+ 1 585-338-8731 FX: 1 585-338-0702 EM: michael.a.santalucia@bausch.com [ADVAMED]
Stitz, Klaus, VP 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]
Updated 20 April 2011
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