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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 5 (SG5) > 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 | |
| Madoka Murakami, Ph.D | Reviewer, Office of Medical Devices I, Pharmaceutical and Medical Devices Agency, JAPAN | MHLW, Japan | murakami-madoka@pmda.co.jp | |
| Jon Rankin | Clinical Adviser Office of Devices, Blood and Tissues Therapeutic Goods Administration Department of Health and Ageing |
TGA, Australia | jon.rankin@tga.gov.au | |
| 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 |
| Mark Gordon | Vice President of Global Regulatory Advocacy and Policy, Boston Scientific |
Advamed (USA) | mark.gordon@bsci.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
|
|
|
Dr Joanne Less 1 |
FDA , USA
|
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 |
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Updated 25 July 2011
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