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ICH Steering Committee and Expert Working Groups

The Steering Committee

The ICH Steering Committee (SC) 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 also oversees the preparations for the series of International Conferences on Harmonisation, which have been held biannually since 1991. The ICH Steering Committee has two Members from each of the six ICH parties (EU, EFPIA, MHW, JPMA, FDA , PhRMA) as well as IFPMA. Representatives of WHO, EFTA and Canada are nominated as Observers on the Steering Committee (see also, Structure of ICH)

The Committee is chaired by one of the regulatory parties and the Chair is rotated, according to the country in which the SC meeting takes place. The Committee normally meets twice a year, with additional meetings in Conference years.

ICH Coordinators for the six ICH parties, and the ICH Secretariat provide administrative support for the Steering Committee.

On technical issues, the Steering Committee is advised by Expert Working Groups


Steering Committee Membership

European Commission - European Union - EU

Prof. J. M. Alexandre Chairman, Committee for Proprietary Medicinal Products (CPMP)
The European Agency for the Evaluation of Medicinal Products, EMEA
(Directeur de l'Evaluation, Agence Française du Médicament, France)
Mr Patrick Deboyser Head of Unit, Pharmaceuticals
DGIII/E/3, European Commission, Brussels

European Federation of Pharmaceutical Industries' Associations - EFPIA

Mr Brian Ager Director General
EFPIA, Brussels
Dr. Yves Juillet Pharma Policy Director
Roussel Uclaf, France <Top of page>

Ministry of Health and Welfare, Japan - MHW

Mr Yasunori Tsuruta Director, Pharmaceuticals and Cosmetics Division
Pharmaceutical Affairs Bureau, MHW, Japan
Mr Kyozo Inari Project Manager for Clinical Trials
Pharmaceutical Affairs Bureau MHW, Japan

Japan Pharmaceutical Manufacturers Association - JPMA

Mr Kazutaka Ichikawa Senior Managing Director
JPMA, Tokyo, Japan
Mr. Osamu Ebi Member of the Board Regulatory Affairs
Takeda Chemical Industries, Ltd, Japan <Top of page>

US Food and Drugs Administration - FDA

Dr Roger L. Williams Associate Director, Science and Medical Affairs
Center for Drug Evaluation & Research (CDER), FDA, USA
Dr. Elaine C. Esber Associate Director for Medical and International Affairs
Center for Biologics Evaluation and Research (CBER), FDA, USA

Pharmaceutical Research and Manufacturers of America - PhRMA

Dr John Beary Senior Vice President for Regulatory and Scientific Affairs
PhRMA, Washington, USA
Dr. Alexander Giaquinto Senior Vice President Worldwide Regulatory Affairs
Schering Plough Research Institute, Kenilworth, NJ, USA <Top of page>

IFPMA

Dr. Richard B. Arnold Executive Vice President
IFPMA, Geneva
Miss Margaret C. Cone Vice President for Scientific Affairs
IFPMA, Geneva

Observers on the ICH Steering Committee

World Health Organization - WHO

Dr J. Idänpään-Heikkilä Director Division of Drug Management & Policies
World Health Organization, Geneva

Canada

Ms. Mary Carman Director
Bureau of Pharmaceutical Assessment
Drugs Programme, Health Canada

European Free Trade Area - EFTA

Dr Rolf Spang Vice Director, Head Registration Department
Intercantonal Office for the Control of Medicines, 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.

European Commission - European Union - EU

Ms Marie Donnelly Administrator,
DGIII/E/3, Pharmaceutical Unit
European Commission, Brussels
Technical Coordinator
Prof. Dr. Rolf Bass
Head of Unit "Evaluation of Human Medicines"
The European Agency for the Evaluation of Medicinal Products (EMEA), London

European Federation of Pharmaceutical Industries' Associations - EFPIA

Ms Emer Cooke Manager Scientiifc and Regulatory Affairs
EFPIA, Brussels

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Ministry of Health and Welfare, Japan - MHW

Dr Toshiyoshi Tominaga Deputy Director Pharmaceuticals and Cosmetics Division
Pharmaceutical Affairs Bureau, MHW, Japan

Japan Pharmaceutical Manufacturers Association - JPMA

Mr Toshikazu Yoshinaga Vice Director, Medical &Scientific Department
JPMA, Tokyo

US Food and Drug Administration - FDA

Ms Janet Showalter FDA's ICH Programme Coordinator
Office of Health Affairs, FDA, USA

Pharmaceutical Research and Manufacturers of America - PhRMA

Mrs Carol McCullough ICH Coordinator
PhRMA, Washington, USA

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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.

Miss Margaret C. Cone Vice President for Scientific Affairs
IFPMA, Geneva
Mr Katsuji Sato ICH and Japan Liaison Executive,
ICH Secretariat c/o IFPMA, Geneva
Mrs Sarah Préperier Secretary, ICH Secretariat, c/o IFPMA, Geneva

ICH Secretariat
c/o IFPMA
30 rue de St-Jean
P.O. Box 9
1211 Geneva 18
Switzerland

Tel: +41 (22) 340 12 00
Fax: +41 (22) 345 82 75
E-mail: ich@ifpma.org

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ICH Expert Working Groups (EWGs)

The ICH Expert Working Groups are joint regulatory/industry Working Groups for which experts are nominated from the six co-sponsors of the Conference. The Working Groups deal with individual harmonisation Topics and each party nominates a Topic Leader for the subject under discussion. For an ICH EWG to meet formally, on ICH business, there must be at least one expert present from each of the six parties: the Topic Leader, Deputy Topic Leader or nominated representative.


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