Directory of Study Group 2 Members

Chair : Demade, Isabelle, Principal Administrator, European Commission, Directorate General for Health and Consumers

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

1. Regulators

► Asia-Pacific

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]

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]

► European Union

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: e.stoesslein@bfarm.de [BfArM]

► North America

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]

Harrison , Barbara , Medical Device Specialist, 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: +1 613-946-5093, FX: +1 613-954-0941, EM: barbara.harrison@hc-sc.gc.ca [Health Canada]

2. Industry Representatives

► Asia- Pacific

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 , C hadaporn (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]

► European Union

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]

► North America

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 22 April 2010

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