The MedDRA Management Board, appointed by the ICH Steering Committee, has overall responsibility for direction of MedDRA, an ICH standardised dictionary of medical terminology. The Board oversees the activities of the MedDRA “Maintenance and Support Services Organisation” (MSSO), which serves as the repository, maintainer, developer and distributor of MedDRA. The Management Board is composed of the six ICH Parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Health Canada and the WHO (as Observer). The IFPMA acts as a non-voting observer on the Management Board and chairs the Board.

 
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EU

Dr. Sébastien Goux

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

Dr. Sabine Brosch (Alternate)

Job Title:Business Lead
EudraVigilance and International Standardisation in Pharmacovigilance
Pharmacovigilance and Risk Management Sector
Address:European Medicines Agency (EMA)
London, UK

MHRA UK

Mr. Mick Foy

Job Title:Group Manager
Vigilance Intelligence and Research Group
Vigilance and Risk Management of Medicines Division
Address:Medicines and Healthcare products Regulatory Agency (MHRA)
London, UK

EFPIA

Mrs. Hilary Vass

Job Title:Global Clinical Dictionary Manager
Address:AstraZeneca Pharmaceuticals
Cheshire, UK

Dr. Christina Winter (Alternate)

Job Title:Medical Director
Global Clinical Safety & Pharmacovigilance
Address:GlaxoSmithKline R&D
Uxbridge, UK

Dr. Barry Hammond (Alternate)

Job Title:Global Dictionary Head
Address:GlaxoSmithKline Research & Development
Hertfordshire, UK

Dr. Omar De Mol (Alternate)

Job Title:EU Qualified Person for Pharmacovigilance
Address:Genzyme
Naarden, The Netherlands

MHLW

Dr. Shinichi Watanabe

Job Title:Director
Office of Safety Promotion, Safety Division
Address:Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour & Welfare (MHLW)
Tokyo, Japan

Ms. Makiko Isozaki (Alternate)

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

Mr. Daisuke Sato (Alternate)

Job Title:Office of Safety II
Address:Pharmaceuticals and Medical Devices Agency (PMDA)
Tokyo, Japan

Mr. Go Yamamoto (Alternate)

Job Title:Section chief
Safety Division
Address:Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour & Welfare (MHLW)
Tokyo, Japan

JPMA

Mr. Yo Tanaka

Job Title:Manager
Biometrics Department
Address:Chugai Clinical Research Center, Chugai Pharmaceutical Co.,
Tokyo, Japan

FDA

Dr. John (Jake) Kelsey

Job Title:Dental Team Leader
Division of Dermatology and Dental Products
Address:Center for Drug Evaluation and Research (CBER), Food & Drug Administration (FDA)
Silver Spring, MD, USA

Dr. Daniela Vanco (Alternate)

Job Title:Medical Officer
Office of Blood Research and Review
Division of Hematology/Clinical Review Branch
Address:Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA)
Rockville, MD, USA

Health Canada

Ms. Heather Sutcliffe

Job Title:Director
Marketed Health Products Safety and Effectiveness Information Division
Address:Health Products and Food Branch, Health Canada
Ottawa, Ontario, Canada

Dr. Christopher Turner (Alternate)

Job Title:Director General
Marketed Health Products Directorate
Address:Health Products and Food Branch, Health Canada
Ottawa, Ontario, Canada

PhRMA

Dr. Paul Lagarenne

Job Title:Vice President, Global Deputy Head
Address:Sanofi-Aventis Global Pharmacovigilance and Epidemiology
Bridgewater, NJ, USA

Ms. JoAnn Medbery (Alternate)

Job Title:Senior Director
Safety Compliance
Address:Johnson & Johnson Consumer Products
Foster City, CA, USA

MSSO

Mr. Patrick W. Revelle

Job Title:MSSO Director
Address:Northrop Grumman Corporation, Maintenance and Support Services Organization (MSSO)
Chantilly, VA, USA

Dr. Patricia Mozzicato (Alternate)

Job Title:Chief Medical Officer
Address:Northrop Grumman Corporation, Maintenance and Support Services Organization (MSSO)
Chantilly, VA, USA

Dr. Anna C. Zhao-Wong (Alternate)

Job Title:Senior Medical Review Officer
Address:Northrop Grumman Corporation, Maintenance and Support Services Organization (MSSO)
Chantilly, VA, USA

JMO

Mr. Osamu Handa

Job Title:Director
Address:Japanese MedDRA Maintenance Organization, Pharmaceutical and Medical Device Regulatory
Tokyo, Japan

Mr. Reiji Tezuka (Alternate)

Job Title:
Address:Japanese MedDRA Maintenance Organization Pharmaceutical, Medical Device Regulatory Science Society of Japan
Tokyo, Japan

IFPMA

Dr. Odette Morin

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

WHO

Dr. Lembit Rägo

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