The ICH Steering Committee (SC) is the governing body that oversees the harmonisation activities. Since its establishment in 1990, each of its six co-sponsors (EU, EFPIA, MHLW, JPMA, FDA, PhRMA) has had two seats on the SC. Other parties have a significant interest in ICH and have been invited to nominate Observers to the SC. The three Observers are the World Health Organization (WHO), Health Canada and the European Free Trade Association (EFTA). The IFPMA participates as a non-voting member of the SC.

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EU

Ms. Lenita Lindström

Job Title:Senior Policy Officer
Pharmaceutical Unit
Address:Directorate General for Health and Consumers
European Commission
Brussels, Belgium

Dr. Tomas Salmonson

Job Title:CHMP Vice Chairman
Address:Medical Products Agency, Preclinical and Clinical Investigation Unit
Uppsala, Sweden

EFPIA

Mr. Richard Bergström

Job Title:Director General
Address:European Federation of Pharmaceutical Industries and Associations (EFPIA)
Brussels, Belgium

Dr. Sabine Luik

Job Title:Sr. Vice President
Medicine & Regulatory Affairs
US Regional Medical Director
Address:Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut

MHLW

Mr. Naoyuki Yasuda

Job Title:Director
International Planning
Address:Ministry of Health, Labour & Welfare (MHLW)
Tokyo, Japan

Dr. Nobumasa Nakashima

Job Title:Office Director
International Programs Office
Address:Pharmaceuticals and Medical Devices Agency (PMDA)
Tokyo, Japan

JPMA

Dr. Kurajiro Kishi

Job Title:Director
Medical & Scientific Department
Address:Japan Pharmaceutical Manufacturers Association (JPMA)
Tokyo, Japan

Dr. Hironobu Saito

Job Title:Vice President
New Drug Regulatory Affairs Department
R&D Center
Address:Daiichi Sankyo Co., Ltd.
Tokyo, Japan

FDA

Dr. Theresa Mullin

Job Title:Director
Office of Strategic Programs
Address:Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
Silver Spring, MD, USA

Ms. Joan Wilmarth Blair

Job Title:Senior Advisor
International Affairs
Address:Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)
Rockville, MD, USA

PhRMA

Dr. Patrick Brady

Job Title:Deputy Vice President
Scientific and Regulatory Affairs
Address:Pharmaceutical Research and Manufacturers of America (PhRMA)
Washington DC, USA

Dr. Peter K. Honig

Job Title:Senior Vice President
Worldwide Regulatory Affairs
Address:Pfizer Inc
Collegeville, NJ, USA

IFPMA

Mr. Eduardo Pisani

Job Title:Director General
Address:International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Geneva, Switzerland

Dr. Odette Morin

Job Title:Director
Regulatory and Scientific Affairs
Address:International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Geneva, Switzerland

EFTA

Dr. Petra Doerr

Job Title:Head of Management Services and Networking
Address:Swissmedic, Swiss Agency for Therapeutic Products
Berne, Switzerland

Health Canada

Mr. Mike Ward

Job Title:Manager
International Programs Division
Address:Bureau of Policy and Coordination Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Ottawa, Canada

Mrs. Louise Déry (Alternate)

Job Title:Director
International Affairs Division
Address:Health Canada
Ottawa, Ontario, Canada

WHO

Dr. Lembit Rägo

Job Title:Coordinator
Quality Assurance and Safety: Medicines, Health Technology & Pharmaceuticals (HTP/EDM/QSM)
Address: World Health Organization (WHO)
Geneva, Switzerland