International Conference on Harmonisation
ICH Steering Committee
Home Structure Committees Process Topics Conferences News Future

The 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 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

Europe

EU

Mr Patrick Deboyser 
Head of Pharmaceuticals and Cosmetics 
DG III 
European Commission 
Brussels, Belgium 

Professor J. M. Alexandre 
Chairman, CPMP 
European Agency for the Evaluation of Medicinal Products 
Canary Wharf, London

EFPIA

Mr Brian Ager 
Director General 
European Federation of Pharmaceutical 
Industries Associations - EFPIA 
Brussels, Belgium 

Dr Yves Juillet 
Pharma Policy Director 
Hoechst Marion Roussel 
France

Japan

MHW

Mr Yasunori Tsuruta 
Director, Pharmaceuticals & Cosmetics Division 
Pharmaceutical and Medical Safety Bureau 
Ministry of Health & Welfare 
Tokyo, Japan 

Mr Kazuo Hirayama 
Manager, First Review Department 
Pharmaceuticals and Medical Devices Evaluation 
Center, Ministry of Health & Welfare 
Tokyo, Japan

JPMA

Mr Kazutaka Ichikawa 
Senior Managing Director 
Japan Pharmaceutical Manufacturers 
Association - JPMA 
Tokyo, Japan 

Mr Osamu Ebi 
Member of the Board 
Regulatory Affairs 
Takeda Chemical Industries, Ltd. 
Tokyo, Japan

USA

FDA

Dr Roger L. Williams 
Associate Director, Science and Medical Affairs 
Center for Drug Evaluation and Research (CDER) 
Food and Drug Administration 
Rockville, MD, USA 

Dr Elaine C. Esber 
Associate Director for Medical and International Affairs,
Center for Biologics Evaluation and Research (CBER) 
Food and Drug Administration 
Rockville, MD, USA

PhRMA

To be Announced
Regulatory and Scientific AffairsRegulatory and Scientific Affairs
PhRMA
Washington DC, USA

Dr Alexander Giaquinto 
Senior Vice President 
Worldwide Regulatory Affairs 
Schering Plough Research Institute 
Kenilworth, NJ, USA

IFPMA

Dr Harvey E. Bale, Jr. 
Director General
International Federation of Pharmaceutical Manufacturers Associations - IFPMA 
Geneva, Switzerland
Miss Margaret Cone 
Vice President for Scientific Affairs 
International Federation of Pharmaceutical Manufacturers Associations - IFPMA 
Geneva, Switzerland

Observers on the ICH Steering Committee

Canada

World Health Organization (WHO)

Ms. Mary Carman 
Director, Bureau of Pharmaceutical Assessment 
Drugs Programme 
Health Canada 
Ottawa 
Canada
Dr Juhana Idänpään-Heikkilä 
Director Division of Drug Management & Policies 
World Health Organization 
Geneva, Switzerland

EFTA

 
Dr Rolf Spang 
Vice Director, Head Registration Department 
Intercantonal Office for the Control of Medicines (IOCM) 
Berne 
Switzerland 
 

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

EFPIA

EU Coordinator 
(To be announced)
DGIII/E/3 
Pharmaceutical Unit 
European Commission 
200 rue de la Loi 
1049 Brussels, Belgium 
Tel: +32 (2) 296 03 32 
Fax: +32 (2) 296 15 20
Ms Emer Cooke 
Manager, Scientific and Regulatory Affairs 
European Federation of Pharmaceutical Industries
Associations - EFPIA 
Avenue Louise 250 
B.P. 91 
1050 Brussels, Belgium 
Tel:  +32 (2) 626 25 55 
Fax: +32 (2) 626 25 66

MHW

JPMA

Dr Toshiyoshi Tominaga 
Deputy Director 
Pharmaceuticals & Cosmetics Division 
Pharmaceutical and Medical Safety Bureau 
Ministry of Health & Welfare 
1-2-2 Kasumigaseki 
Chiyodaku 
Tokyo 100-45, Japan 
Tel: + 81 (3) 3595 2431 
Fax: + 81 (3) 3597 9535
Mr Toshikazu Yoshinaga 
Vice Director, Medical & Scientific Department 
Japan Pharmaceutical Manufacturers Association - JPMA 
Torii Nihonbashi Building 
3-4-1 Nihonbashi-Honcho 
Chuo-ku 
Tokyo 103, Japan 
Tel: +81 (3) 3241 0326 
Fax: +81 (3) 3242 1767 

FDA

PhRMA

Ms Janet Showalter 
FDA's ICH Programme Coordinator 
Food and Drug Administration 
Office of Health Affairs 
5600 Fishers Lane, HFY-50 
Room 15-22, Parklawn Building 
Rockville, Maryland 20857 
USA 
Tel: +1 (301) 827 0865 
Fax: +1 (301) 443 0232
Ms Carol McCullough 
ICH Coordinator for PhRMA 
7021 Enterprise Ave. 
McLean, VA 22101 
USA 
Tel: +1 (703) 442 0497 
Fax: +1 (703) 442 8679 

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 Documantation are available from the ICH Secretariat. See Topic Page for further details.

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

ICH Expert Working Groups (EWGs)

For each of the technical topics which have been selected for harmonisation in the first phase of activities, the SC appointed an Expert Working Group (EWG) to review the differences in requirements between the three regions and develop scientific consensus required to reconcile those differences. EWGs do not have a fixed "membership" but each of the six parties have nominated a Topic Leader (and, frequently, a Deputy Topic Leader) as the contact for the topic. The Observers to ICH, the Pharmacopoeial authorities and representatives from the self-medication industry and the generic industry have been invited to participate in various EWGs.

One of the working principles agreed by the SC was that an EWG could only meet in its official ICH capacity if there was at least one nominated expert from each of the six ICH co-sponsors.


Schedule of ICH Meetings

April 1990 ICH Steering Committee (SC), Inaugural Meeting, Brussels
Oct. 1990 SC and Expert Working Groups (EWGs), Tokyo
Jan. 1991 SC and EWGs, Washington
April 1991 SC and EWGs, Washington
November 1991: First International Conference on Harmonisation, Brussels, Belgium
March 1992 SC and EWGs, Washington
Sept. 1992 SC and EWGs, Tokyo
March 1993 SC and EWGs, Brussels
June 1993 SC and EWGs, Washington
October 1993: Second International Conference on Harmonisation, Orlando, USA
March 1994 SC and EWGs, Tokyo
Oct. 1994 SC and EWGs, Brussels
March 1995 SC and EWGs, Washington
July 1995 SC and EWGs, Brussels
November 1995: Third International Conference on Harmonisation, Yokohama, Japan
May 1996 SC and EWGs, Virginia, USA
July 1996 SC (special planning meeting), Geneva
Nov. 1996 SC and EWGs, London
March 1997 SC and EWGs, Narita, Japan
July 1997: Fourth International Conference on Harmonisation, Brussels, Belgium
Feb. 1998 SC and EWGs, Virginia, USA

Copyright©1998 International Federation of Pharmaceutical Manufacturers Associations