Ad Hoc Working Groups

* see GHTF Steering Committee Members for contact information
+ see the Ad Hoc Working Group Chart below for contact information

Global Model Ad Hoc Working Group

Beginning Date: 2 October 2007
Chair: Johann Brinch
Members: Hiroshi Ishikawa, Roland Rotter, Terry Sweeney, Nicole Denjoy

Unique Device Identification Working Group

Beginning Date 8 October 2008 (Ottawa SC Meeting)
Chair: Laurent Selles
Members: Jay Crowley, Jeff Secunda, Tom Werthwine, Jackie Elkin, Hiroshi Ishikawa, Prof. Yan Liang, Lindsay Tao, Christopher Rose, Christine Tarrajat, Matthias Neumann, Rodolphe Muñoz, Volker Zeinar

Regulatory Change Management Ad Hoc Working Group

Beginning Date12 November 2009
Chair: Gary Burgess
Members: Gary Burgess Johan Brinch, Kentauro Azuma, Michael Gropp, Mark Melkerson .

+ GHTF Ad Hoc Working Group Members

NAME	AFFILIATION	EMAIL
Kentauro Azuma	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	azuma-kentarou@mhlw.go.jp
Gary Burgess	Therapeutic Goods Administration Director, Market Authorisation Group, Office of Devices Authorisation, Devices Conformity Assessment PO Box 100 WODEN ACT 2606 AUSTRALIA Tel: +61 2 6232 8514 Fax: +61 2 6232 8785 Email: gary.burgess@tga.gov.au	gary.burgess@tga.gov.au
Johan Brinch	Cochlear Limited 14 Mars Road Lane Cove, NSW 2066 AUSTRALIA Tel: +61 2 9428 6560 Fax: +61 2 9428 6539	jbrinch@cochlear.com
Jay Crowley	FDA Senior Advisor for Patient Safety Center for Devices and Radiological Health Food and Drug Administration Phone: 301-980-1936	jay.crowley@fda.hhs.gov
Nicole Denjoy	Secretary General COCIR Diamant Building 80 Bd. A Reyers B-1030 BRUSSELS Tel: +32 (0) 2 706 89 61 Fax: +32 (0) 2 706 89 69	denjoy@cocir.org
Jackie Elkin	Global Process Owner – Standard Product Identification Initiatives Medtronic, Inc Corporate Global Regulatory Operations 710 Medtronic Parkway, MS LS330 MINNEAOPOLIS, MN Tel: (+1-763) 505-2575 Fax: (+1-763) 505 8205	jackie.elkin@medtronic.com
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	michael.b.gropp@medtronic.com
Hiroshi Ishikawa	Assistant to President Toshiba Medical Systems Corporation 1385 Shimoishigami Ootawara shi Tochigi 324-855 JAPAN Tel: +81 287 26 6774 Fax: +81 287 26 6050	hiroshi4.ishikawa@toshiba.co.jp
Prof Yan Liang	SFDA Shanghai - Senior Advisor of International & Legal Affairs Shanghai Municipal Food & Drug Administration(SH-FDA) Shanghai Institute of Food & Drug Safety(SIFDS) No.615 Liu Zhou Road. Shanghai PR.China 200233. Tel:+86-21 6167 3735; Fax:+86-21 6451 1851;	yanliang@smda.gov.cn yanliang@online.sh.cn
Mark Melkerson	US Food and Drug Administration Director, Division of General, Restorative and Neurological Devices CDRH/Office of Device Evaluation 9200 Corporate Blvd., HFZ-410, 350C Rockville, MD 20850 UNITED STATES Tel +1 240 276 3737 Fax +1 240 276 3602	mark.melkerson@fda.hhs.gov
Rodolphe Muñoz	European Commission DG SANCO Health & Consumer Unit B2 – Cosmetics and Medical Devices BREY 10/158, Avenue d'Auderghem 45 - 1049 Brussels, BELGIUM	Rodolphe.munoz@ec.europa.eu
Matthias Neumann	Bundesministerium für Gesundheit Referat 116 "Medizinprodukte" Federal Ministry of Health Division 116 "Medical Devices" Friedrichstraße 108 10117 Berlin Tel. +49 (0) 30 20640 2636 Fax. +49 (0) 30 20640 4838	matthias.neumann@bmg.bund.de
Christopher Rose	Health Products and Food Branch Inspectorate Room 359, 250 Lanark Ave. Ottawa, Ontario K1A 0K9 Tel: 613-954-6666 Fax: 613-954-0941	christopher.rose@hc-sc.gc.ca
Roland Rotter	Director - Medical Devices Bureau Therapeutic Products Directorate Health Canada 1st Floor, Room 1605, Main Statistics Canada Building 150 Tunney's Pasture Driveway, Tunney's Pasture Address Locator: 0301H1 Ottawa, Ontario K1A OK9 CANADA Tel: +1 613 957 4786 Fax: +1 613 957 7318	Roland_Rotter@hc-sc.gc.ca
Jeff Secunda	Advamed Vice President, Technology & Regulatory Affairs 701 Pennsylvania Ave. NW Washington, DC 20004 +1-202-434-7224 +1-202-783-8700	JSecunda@AdvaMed.org
Laurent Sellès	European Commission DG SANCO Health & Consumer Unit B2 – Cosmetics and Medical Devices BREY 10/177, Avenue d'Auderghem 45 - 1049 Brussels, BELGIUM	Laurent.selles@ec.europa.eu
Terry Sweeney	Sr. Vice President Corporate Quality and Regulatory Affairs Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98041-3003 UNITED STATES Tel: +1 425-487-7602 Fax: +1 425-487-8666	terry.sweeney@philips.com
Lindsay Tao	Corporate Director Regulatory Government Affairs, Asia Pacific 4th F, Chengkai International Center 355 Hong Qiao Rd, Shanghai, CHINA 200030 Tel: + 86-21-22058288(phone) Fax: * 86-21-22059262	LTAO@its.jnj.com
Christine Tarrajat	EDMA - European Diagnostic Manufacturers Association Place des Maïeurs 2 § B-1150 Brussels Direct Tel. +32 2 777 0271 Mobile. +32 475 464 182	c.tarrajat@edma-ivd.be
Tom Werthwine	Johnson & Johnson Global Process Owner, Auto ID Technology & Data Standards Johnson & Johnson Health Care Systems Inc 425 Hoes Lane Piscataway NJ 08854 US Tel: 01 732 562 3293	TWerthwi@its.jnj.com
Volker Zeinar	Global Coordination Auto-ID Affairs B Braun Melsungen AG Phone +49 (5661) 71-4328 Fax +49 (5661) 75-4328	volker.zeinar@bbraun.com

Updated 15 October 2010

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