Fundamental to the smooth running of ICH has been the designation, by each of the six co-sponsors, of an ICH Coordinator to act as the main contact point with the ICH Secretariat. Coordinators ensure proper distribution of ICH documents to the appropriate persons from their party (SC members, Topic Leaders, Experts) and are responsible for proper follow up on actions by their respective party within assigned deadlines.

Due to the structural differences within the European Union (EU) and the Ministry of Health, Labour and Welfare (MHLW), ICH Technical Coordinators are also designated from the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA) respectively. They support the ICH Coordinator and facilitate every action of the Steering Committee members in the region, mainly by applying their scientific knowledge. Their roles include acting as a contact point between the experts within the EMA or PMDA and the ICH Coordinator at the main regulatory body, and as a contact point with the ICH Secretariat.

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EU

Technical Coordinator for EU

Dr. Sébastien Goux

Job Title:Pharmaceutical Unit
Address:Directorate General for Health and Consumers
European Commission
BREY 10/091, Avenue D'Auderghem 45, BE - 1049 Brussels, Belgium
Tel:+32 (0) 2 292 1555
Fax:+32 (0) 2 299 8046
E-mail:sebastien.goux@ec.europa.eu

Dr. Spiros Vamvakas

Job Title:Principal Scientific Administrator
Scientific Advice and Orphan Drugs Sector
Address:European Medicines Agency (EMA)
7, Westferry Circus, Canary Wharf, London E14 4HB, UK
Tel:+44 20 7523 7006
Fax:+44 20 7523 7040
E-mail:Spiros.Vamvakas@ema.europa.eu

EFPIA

Ms. Stephanie Lane

Job Title:Director
International Government Affairs
Address:European Federation of Pharmaceutical Industries Associations (EFPIA)
108 rue du Trone, BP 11050 Brussels, Belgium
Tel:+32 (0) 2 626 25 45
Fax:+32 (0) 2 626 25 66
E-mail:stephanielane@efpia.org

MHLW

Technical Coordinator for MHLW

Ms. Yasuko Inokuma

Job Title:Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau
Address:Ministry of Health, Labour and Welfare (MHLW)
1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan
Tel:+81 (3) 3595 2431
Fax:+81 (3) 3597 9535
E-mail:inokuma-yasuko@mhlw.go.jp

Dr. Jun Kitahara

Job Title:Division Director
Division of Regulatory Cooperation
Office of International Programs
Address:Pharmaceuticals and Medical Devices Agency (PMDA)
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyodaku, Tokyo 100-0013, Japan
Tel:+81 3 3506 9456
Fax:+81 3 3506 9572
E-mail:kitahara-jun@pmda.go.jp

JPMA

Dr. Kurajiro Kishi

Job Title:Director
Medical & Scientific Department
Address:Japan Pharmaceutical Manufacturers Association (JPMA)
Torii Nihonbashi Building,3-4-1 Nihonbashi-Honcho,Chuo-ku, Tokyo 103-0023, Japan
Tel:+81 (3) 3241 0326
Fax:+81 (3) 3242 1767
E-mail:kishi@jpma.or.jp

FDA

Dr. C. Michelle Limoli

Job Title:Director
Harmonization and Multilateral Relations Office
Address:Office of International Programs, U.S. Food and Drug Administration (FDA)
10903 New Hampshire Avenue WO 31 - 3506 Silver Spring, MD 20993-0002 USA
Tel:+1 (301) 796 8377
Fax:+1 (301) 595 5056
E-mail:michelle.limoli@fda.hhs.gov

PhRMA

Dr. Michael Garvin

Job Title:Assistant Vice President
Address:Pharmaceutical Research and Manufacturers of America (PhRMA)
Suite 300, 950F Street, NW, Washington, DC 20004, USA
Tel:+1 (202) 835 3544
Fax:+1 (202) 835 3597
E-mail:mgarvin@phrma.org