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

Mr. Sébastien Goux

Job Title:Directorate General
Health and Consumers
Address:European Commission, Unit D5 Medicinal Products - Authorisations, EMA
Brussels, Belgium

Ms. Lenita Lindström-Gommers

Job Title:Senior Expert
Address:European Commission / Directorate General for Health and Food Safety
Brussels, Belgium

Dr. Tomas Salmonson

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

MHLW/PMDA

Dr. Nobumasa Nakashima

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

Mr. Naoyuki Yasuda

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

FDA

Dr. Theresa Mullin

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

Ms. Joan Wilmarth Blair

Job Title:Senior Advisor
International Affairs
Address:U.S. Food and Drug Administration Center for Biologics Evaluation and Research
Silver Spring, MD, USA

Health Canada

Ms. Catherine Parker

Job Title:A/ Senior Executive Director
Address:Health Products and Food Branch Biologics and Genetic Therapies Directorate
Ottawa, Ontario, 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
Address:Medicine & Regulatory Affairs US Regional Medical Director, NA Boehringer Ingelheim Pharmaceuticals, Inc
Ridgefield, Connecticut, USA

JPMA

Dr. Hironobu Saito

Job Title:Vice President

Address:New Drug Regulatory Affairs Department R&D Division
Tokyo, Japan

Mr. Takuya Saiki

Job Title:Associate Director
Address:Clinical Science, Takeda Development Center Japan, Takeda Pharmaceutical Company Limited
Osaka, Japan

PhRMA

Dr. Rajesh Ranganathan

Job Title:Vice President
Address:Pharmaceutical Research and Manufacturers of America - PhRMA, Scientific & Regulatory Advocacy
Washington DC, USA

Dr. Peter K. Honig

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

IFPMA

Ms. Caroline Mendy

Job Title:Senior Manager, Regulatory Policy
Address:International Federation of Pharmaceutical Manufacturers and Associations - IFPMA
Geneva, Switzerland

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

Mr. Mike Ward

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