The ICH
Steering Committee
The ICH Steering Committee
(SC) was established in April 1990, when ICH was initiated. The Steering
Committee, working within the ICH Terms of Reference, determines the policies and
procedures for ICH, selects topics for harmonisation and monitors the progress
of harmonisation initiatives. The Steering Committee meets at least twice a
year. (See Schedule
of EWG Meetings)
This page gives the
Steering Committee Members for the six ICH co-sponsors, from Europe,
Japan and USA, and the
members for IFPMA and the Observers.
Full Coordinates are given for the ICH Coordinators
and the ICH Secretariat.
Steering
Committee Members
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EUROPE
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EU
Ms. Lenita Lindström-Rossi
Senior Policy Officer
Unit F2 - Pharmaceuticals
Enterprise and Industry Directorate-General
European Commission
Brussels, Belgium
Dr. Tomas Salmonson
CHMP Vice Chairman
Medical Products Agency
Preclinical and Clinical
Investigation Unit
Uppsala, Sweden
|
EFPIA
Dr. Christine-Lise Julou
Director, Scientific Technical Regulatory Affairs
European Federation of Pharmaceutical
Industries Associations - EFPIA
Brussels, Belgium
Dr. André W. Broekmans
Vice President, Regulatory Policy and Intelligence
Schering Plough Research Institute
The Netherlands
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JAPAN
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MHLW
Mr. Shinobu Uzu
International Planning Director
Ministry of Health, Labour & Welfare
Tokyo, Japan
Dr. Satoshi Toyoshima
Executive Director
Pharmaceuticals and Medical
Devices Agency (PMDA)
Tokyo, Japan
|
JPMA
Mr. Kazutaka Ichikawa
Senior Managing Director
Japan Pharmaceutical Manufacturers
Association - JPMA
Tokyo, Japan
Mr. Kohei Wada
General Manager
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd.
Tokyo, Japan
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USA
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FDA
Dr. Justina A. Molzon
Associate Director for International
Affairs
Center for Drug
Evaluation and Research (CDER)
Food and Drug Administration
Rockville, MD, USA
Dr. Robert A. Yetter
Associate Director for Review Management
Center for
Biologics Evaluation and Research (CBER)
Food and Drug Administration
Rockville, MD, USA
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PhRMA
Dr. Alice Till
Vice President
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of America
- PhRMA
Washington DC, USA
Dr. Peter K. Honig
Executive Vice President
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories
North Wales, PA, USA
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IFPMA
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Mme Alicia D.
Greenidge
Director General
International Federation of Pharmaceutical
Manufacturers Associations - IFPMA
Geneva, Switzerland
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Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers Associations - IFPMA
Geneva, Switzerland
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Observers on the ICH
Steering Committee
Canada
Mr. Mike Ward
Manager, International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower 'B', 2nd Floor
1600 Scott St.
Ottawa, Ontario K1A 1B6
Canada
|
World Health Organization (WHO)
Dr. Lembit Rägo
Coordinator
Quality Assurance and Safety : Medicines
HTP/EDM/QSM
World Health Organization
Geneva, Switzerland
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EFTA
Dr. Petra
Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne
Switzerland
|
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ICH Coordinators
Each of the six co-sponsors
has nominated an ICH Coordinator to act as the main contact point with the ICH
Secretariat and ensure that ICH documents are distributed to the appropriate
persons within the area of their responsibility.
Each party has also
established a Contact Network of experts within their own organisation
or region in order to ensure that, in the discussions, they reflect the views
and policies of the co-sponsor they represent. The organisation
of this communication differs according to the administrative structure of the
party concerned.
EU
Dr. Matus Ferech
Pharmaceuticals Unit
European Commission
Avenue d'Auderghem, 45
1049 Brussels
Belgium
Tel: +32 (2) 298 42 60
Fax: +32 (2) 299 80 46
E-mail: matus.ferech@ec.europa.eu
|
EFPIA
Dr. Elisa Siviglia
Assistant Manager
Scientific, Technical & Regulatory Affairs
European Federation of Pharmaceutical Industries Associations - EFPIA
108 rue du Trône, BP 1
1050 Brussels
Belgium
Tel : +32 (2) 626 25 52
Fax : +32 (2) 626 25 66
E-mail: elisasiviglia@efpia.org
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MHLW
Mr. Takayuki Okubo
Section Chief
Evaluation and Licensing Division
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare
1-2-2, Kasumigaseki Chiyoda-ku
Tokyo 100-8916
Japan
Tel : +81 (3) 3595 2431
Fax : +81 (3) 3597 9535
E-mail: ookubo-takayuki@mhlw.go.jp
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JPMA
Dr. Kurajiro Kishi
Director, Medical & Scientific Department
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
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FDA
Dr. C. Michelle Limoli
Associate Director for EU
Office of International Programs
Room 15A-55, Mail Stop HFG-1
Food and Drug Administration
Office of Health Affairs
5600 Fishers Lane
Rockville, Maryland 20817
USA
Tel: +1 (301) 827 0908
Fax: +1 (301) 827 0003
E-mail : michelle.limoli@fda.hhs.gov
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PhRMA
Dr. Michael Garvin
Senior Director
Scientific and Regulatory Affairs
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
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Technical Coordinator for EU
(EMEA)
Dr. Spiros Vamvakas
Principal Scientific Administrator
Scientific Advice and Orphan Drugs Sector
EMEA
7, Westferry Circus, Canary
Wharf
London E14 4HB
UK
Tel : +44 20 7523 7006
Fax : +44 20 7523 7040
E-mail : Spiros.Vamvakas@emea.europa.eu
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Technical Coordinator for MHLW
(PMDA)
Dr. Yoshiaki Uyama
Review Director
Project Leader for PGx
Office of New Drug III
Pharmaceuticals & Medical Devices Agency (PMDA)
Shin-Kasumigaseki Building 9F
3-3-2 Kasumigaseki, Chiyodaku
Tokyo 100-0013
Japan
Tel : +81 3 3506 9452
Fax :+81 3 3506 9453
E-mail : uyama-yoshiaki@pmda.go.jp
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ICH Secretariat
The ICH Secretariat is
provided by IFPMA, Geneva.
The role is primarily concerned with preparations for, and documentation of,
meetings of the Steering Committee as well as coordination of preparations for
EWG meetings and six-party drafting groups. At the time of ICH Conferences, the
Secretariat is responsible for the technical documentation and for liaison with
the speakers for the Conference itself.
ICH Guidelines and
Documentation are available from the ICH Secretariat.
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Dr.
Odette Morin
Director of Regulatory and Scientific Affairs
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Dr. Dawn Ronan
ICH Manager
|
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Dr.
Sarah Adam
ICH Coordinator
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Ms. Friederike Schöch
ICH Assistant
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Ms.
Sarah Renaud
ICH Secretary
|
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ICH Secretariat
c/o IFPMA
15, chemin Louis-Dunant
P.O. Box 195
1211 Geneva 20
Switzerland
Tel: +41 (22) 338 32 06
Fax: +41 (22) 338 32 30
E-mail: admin@ich.org
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