The ICH Steering Committee (SC) is the governing body that oversees the harmonisation activities of ICH. The SC has representatives from the six Founding Parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), and from Swissmedic and Health Canada. Since the outset of ICH, WHO has participated as an Observer to the SC. The IFPMA participates as a non-voting member of the SC.

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EU

Ms. Lenita Lindström-Gommers

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

MHLW/PMDA

Dr. Nobumasa Nakashima

Job Title:International Planning Director
Pharmaceutical Safety and Environmental Health Bureau
Address:Ministry of Health, Labour & Welfare (MHLW)
Tokyo, Japan

Mr. Naoyuki Yasuda

Job Title:Office Director
Office of International Programs
Address:Pharmaceuticals and Medical Devices Agency (PMDA)
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)
Silver Spring, MD, USA

Health Canada

Ms. Catherine Parker

Job Title:Senior Executive Director
Biologics and Genetic Therapies Directorate
Address:Health Products and Food Branch
Health Canada
Ottawa, Canada

Swissmedic

Dr. Petra Doerr

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

Ms. Cordula Landgraf

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

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

JPMA

Dr. Akira Kawahara

Job Title:Senior Managing Director
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

PhRMA

Dr. Rajesh Ranganathan

Job Title:Vice President, Scientific & Regulatory Advocacy
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:Senior Advisor
Regulatory and Scientific Affairs
Address:International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Geneva, Switzerland

WHO

Dr. Lembit Rägo

Job Title:Head, Regulation of Medicines and other Health Technologies
Essential Medicines and Health Products
Address: World Health Organization (WHO)
Geneva, Switzerland

Mr. Mike Ward

Job Title:Coordinator
Regulatory Systems Strengthening - Department of Essential Medicines and other Health Products
Address: World Health Organization (WHO)
Geneva, Switzerland