Directory of Study Group 5 Members

Core members

*Jurisdiction*	*Member*	*Title*	*Nominating Organisation*	*Contact Details*
Europe	Susanne Ludgate Chair	Clinical Director (Devices) Medicines and Healthcare products Regulatory Agency (MHRA) UNITED KINGDOM	European Commission	Susanne.Ludgate@mhra.gsi.gov.uk
	Wolfgang Ecker	Head, Pharmaceuticals and Medical Devices, Federal Ministry of Health, Family and Youth AUSTRIA	European Commission	wolfgang.ecker@bmgfj.gv.at
	Isabel Scuntaro	Medical Devices Division, Swissmedic, SWITZERLAND	European Commission	isabel.scuntaro@swissmedic.ch
	Peter Rattke	Corporate Director of Quality Management and Regulatory Affairs MED-EL Elektromedizinische Geraete GmbH AUSTRIA	EMIG (COCIR)	peter.rattke@medel.com
	Benny Ons	Director, Regulatory Affairs and Quality Management Europe BD Biosciences, Erembodegem BELGIUM	EMIG (EDMA)	benny_ons@europe.bd.com
	Christophe Bailleul	Clinical Director Europe, Middle East, Africa and Canada St Jude Medical BELGIUM/FRANCE	EMIG (EUCOMED)	cbailleul@sjm.com
Asia-Pacific	Johan Brinch	VP Regulatory Affairs Cochlear Ltd AUSTRALIA	MIAA, Australia	jbrinch@cochlear.com.au
	Guy Hibbins	Medical Adviser, Clinical Section, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, AUSTRALIA	TGA, Australia	guy.hibbins@health.gov.au
	Atushi Tamura	Co-ordination Director Office of Medical Devices Pharmaceutical and Medical Devices Agency JAPAN	MHLW, Japan	tamura-atushi@.pmda.co.jp
	Kazuhiro Sase	Professor, Clinical Pharmacology Juntendo University Medical School Juntendo University JAPAN	MHLW, Japan	sase@skyblue.ocn.ne.jp
	Yoshihiro Noda	Senior Staff, QA Division TERUMO Corporation JAPAN	JFMDA, Japan	Yoshihiro_Noda@terumo.co.jp
North America	Herbert Lerner	Center for Devices, and Radiological Health Food and Drug Administration USA	FDA , USA	herbert.lerner@fda.hhs.gov
	Barbara Westrum	Director, Corporate Clinical Affairs, Medtronic Inc. USA	AdvaMed , USA	barbara.westrum@medtronic.com
	Louise Ebbert	Senior Manager, Clinical Operations and Compliance, Siemens USA	Medical Imaging and Technology Alliance (a division of NEMA)	louise.ebbert@siemens.com
	Mitchell Krucoff	Professor, Medicine/Cardiology Duke University Medical Centre Director, Cardiovascular Devices Unit Duke Clinical Research Institute USA	FDA , USA	kruco001@mc.duke.edu
	Maria Carballo	Head, In-Vitro Diagnostic Device Section, Device Evaluation Division Health Canada CANADA	Health Canada	maria_carballo@hc-sc.gc.ca
	Greg LeBlanc Vice-Chair	Manager, Regulatory Affairs and Quality Systems, Cook ( Canada) Inc. CANADA	MEDEC, Canada	gregleblanc@cookcanada.com

‘Associate’ members

Jurisdiction

Nomination

Title

Nominating Organisation

Contact Details

North America

Dr Gregory Campbell 1

FDA , USA

gregory.campbell@fda.hhs.gov

Dr Joanne Less 1

FDA , USA

joanne.less@fda.hhs.gov

1 Expertise available to assist with design and execution of clinical trials – to attend meetings when these issues are being addressed

MIAA

AdvaMed	Advanced Medical Technology Association	COCIR	The European Coordination Committee of the Radiological and Electromedical Industry
EDMA	European Diagnostic Manufacturers Association	EMIG	European Medical Industry Group (affiliated with European Medical Device and Equipment Trade Associations)
EUCOMED	The European Medical Technology Industry Association	MEDEC	Medical Devices Association Canada
JFMDA	Japanese Federation of Medical Devices Associations	NEMA	National Electrical Manufacturers Association
MIAA	Medical Industry Association of Australia

Updated 12 September 2007

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