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Acknowledgements

Special acknowledgement is made to:

Mrs W. Bonny, Medicines Quality Assurance (MQA), Technologies Standards and Norms (TSN), Ms E. Cooke, Head, Regulation of Medicines and other Health Technologies (RHT) and acting Coordinator, TSN, Mrs X. Finnerty, MQA, Dr V. Gigante, MQA, Dr S.R. Hill, Director, Department of Essential Medicines and Health Products (EMP) and Assistant Director-General, Health Systems and Innovation Cluster, Dr S. Kopp, Group Lead, MQA, Dr H. Schmidt, MQA, Mr D. Mubangizi, Coordinator, Prequalification Team (PQT), Ms J.K. Sawyer, Liaison Officer, EMP, Dr M.M. Stahl, Group Lead, Medicines Assessment, PQT and Ms M. Zweygarth, Geneva, Switzerland, who were instrumental in the preparation and proceedings of the meeting.

Technical guidance included in this report has been produced with the financial assistance of the European Union, the Bill & Melinda Gates Foundation, the Department of Health, Hong Kong SAR, China (Hong Kong, Hong Kong SAR, China), Health Canada (Ottawa, Canada), the Ministry of Health, Labour and Welfare, Japan (Tokyo, Japan), the Reproductive, Maternal, Newborn and Child Health Fund and UNITAID.

The Committee also acknowledged with thanks the valuable contributions made to its work by the following agencies, institutions, organizations, pharmacopoeias, WHO Collaborating Centres, WHO programmes, especially PQT, and persons:

Active Pharmaceutical Ingredients Committee, European Chemical Industry Council, Brussels, Belgium; Belgian Association of the Pharmacists of the Pharmaceutical Industry, Meerbeke, Belgium; Asia-Pacific Economic Cooperation, Singapore; Brazilian Health Surveillance Agency/ANVISA, Brasilia, DF, Brazil; Commonwealth Pharmacists Association, London, England; European Commission, Brussels, Belgium; European Directorate for the Quality of Medicines & HealthCare on behalf of the European Pharmacopoeia, Council of Europe, Strasbourg, France; European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium; European Generic and Biosimilars Medicines Association, Brussels, Belgium; European Generic Medicines Association, Brussels, Belgium; European Medicines Agency, London, England; The Global Fund to Fight AIDS, Tuberculosis and Malaria, Vernier, Switzerland; International Atomic Energy Agency, Vienna, Austria; International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland; International Generic and Biosimilar Medicines Association, Brussels, Belgium; International Pharmaceutical Excipients Council – Americas, Arlington, VA, USA; International Pharmaceutical Excipients Council Europe, Brussels, Belgium; International Pharmaceutical Federation, The Hague, Netherlands; International Society for Pharmaceutical Engineering, Tampa, Florida, USA; International Society for Pharmaceutical Engineering,Thousand Oaks, CA, USA; Latin American Association of Pharmaceutical Industries, Buenos Aires, Argentina; Medicines and Healthcare Products Regulatory Agency, Inspection, Enforcement and Standards Division, London, England; Pan-American Network for Drug Regulatory Harmonization, Washington, DC, USA; Parenteral Drug Association, Bethesda, Maryland, USA; Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; The Stop TB Partnership, Geneva, Switzerland; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland; Therapeutic Goods Administration, Woden, ACT, Australia; United Nations Children's Fund, Supply Division, Copenhagen, Denmark; United Nations Children's Fund, New York, USA; United Nations Development Programme, New York, USA; United Nations Industrial Development Organization, Vienna, Austria; The World Bank, Washington, DC, USA; World Intellectual Property Organization, Geneva, Switzerland; World Self-Medication Industry, Nyon, Switzerland; World Trade Organization, Geneva, Switzerland.

Laboratoire National de Contrôle des Produits Pharmaceutiques, Chéraga, Alger, Algeria; Instituto Nacional de Medicamentos, Buenos Aires, Argentina; Expert Analytic Laboratory, Centre of Drug and Medical Technology Expertise, Yerevan, Armenia; Laboratoire national de contrôle de qualité des médicaments et consommables médicaux, Cotonou, Benin; Agency for Medicinal Products and Medical Devices, Control Laboratory, Sarajevo, Bosnia and Herzegovina; Instituto Nacional de Controle de Qualidade em Saúde, Rio de Janeiro, Brazil; Laboratoire National de Santé Publique, Ouagadougou, Burkina Faso; National Product Quality Control Centre, Ministry of Health, Phnom Penh, Cambodia; Laboratoire National de Contrôle de Qualité des Médicaments et d'Expertise, Yaoundé, Cameroon; Departamento de Control Nacional, Unidad de Control de Calidad de Medicamentos comercializados, Institutu de Salud Pública, Santiago de Chile, Chile; National Institutes for Food and Drug Control, Beijing, People's Republic of China; Medicamentos y Productos Biológicos del INVIMA, Bogotá, Colombia; Laboratorio de Análisis y Asesoría Farmacéutica, Facultad de Farmacia, Universidad de Costa Rica, San José, Costa Rica; Laboratorio de Normas y Calidad de Medicamentos, Caja Costarricense de Seguro Social, Universidad de Costa Rica, Alajuela, Costa Rica; Laboratoire National de la Santé Publique, Abidjan, Côte d'Ivoire; Oficina Sanitaria Panamericana, OPS/OMS, Havana, Cuba; National Organization for Drug Control and Research, Cairo, Egypt; Drug Quality Control and Toxicology Laboratory, Drug Administration and Control Authority, Addis Ababa, Ethiopia; Centrale Humanitaire Médico-Pharmaceutique, Clermont-Ferrand, France; Food and Drugs Board, Quality Control Laboratory, Accra, Ghana; Laboratoire national de contrôle de qualité des medicaments, Conakry, Guinea; Laboratory for Quality Evaluation and Control, National Institute of Pharmacy, Budapest, Hungary; Central Drugs Laboratory, Kolkata, India; Provincial Drug and Food Quality Control Laboratory, Yogyakarta, Indonesia; Food and Drugs Control Laboratories, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran; Caribbean Regional Drug Testing Laboratory, Kingston, Jamaica; Mission for Essential Drugs and Supplies, Nairobi, Kenya; National Quality Control Laboratory for Drugs and Medical Devices, Nairobi, Kenya; Food and Drug Quality Control Center, Ministry of Health, Vientiane, Lao People's Democratic Republic; Laboratoire de Contrôle de Qualité des Médicaments, Agence du Médicament de Madagascar, Antananarivo, Madagascar; Centre for Quality Control, National Pharmaceutical Control Bureau, Petaling Jaya, Selangor, Malaysia; Laboratoire National de la Santé du Mali, Bamako, Mali; Laboratoire National de Contrôle des Médicaments, Rabat, Morocco; Quality Surveillance Laboratory, Windhoek, Namibia; National Medicines Laboratory, Department of Drug Administration, Kathmandu, Nepal; Laboratoire National de Santé Publique et d'Expertise, Niamey, Niger; Central Quality Control Laboratory, Directorate General of Pharmaceutical Affairs and Drug Control, Ministry of Health, Muscat, Oman; Drug Control and Traditional Medicine Division, National Institute of Health, Islamabad, Pakistan; Instituto Especializado de Análisis, Universidad de Panamá, Panama; Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru; Bureau of Food and Drugs, Department of Health, Muntinlupa City, Philippines; Laboratory for Quality Control of Medicines, Medicines Agency, Ministry of Health, Chisinau, Republic of Moldova; National Drug and Cosmetic Control Laboratories, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Laboratoire National de Contrôle des Médicaments, Dakar Etoile, Senegal; Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; Centre for Quality Assurance of Medicines, Faculty of Pharmacy, North-West University, Potchefstroom, South Africa; Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, South Africa; National Drug Quality Assurance Laboratory, Ministry of Health, Colombo, Sri Lanka; National Drug Quality Control Laboratory, Directorate General of Pharmacy, Federal Ministry of Health, Khartoum, Sudan; Pharmaceutical Analysis Laboratory, R&D, The School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, United Republic of Tanzania; Tanzania Food and Drug Authority, Dar-es-Salaam, United Republic of Tanzania; Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Laboratoire National de Contrôle des Médicaments, Tunis, Tunisia; National Drug Quality Control Laboratory, National Drug Authority, Kampala, Uganda; Central Laboratory for Quality Control of Medicines of the Ministry of Health of Ukraine, Kiev, Ukraine; Laboratory of Pharmaceutical Analysis, State Pharmacological Centre, Ministry of Health of Ukraine, Kiev, Ukraine; Laboratorio Control de Productos MSP, Comisión Para El Control de Calidad de Medicamentos, Montevideo, Uruguay; Instituto Nacional de Higiene “Rafael Rangel”, Caracas, Venezuela; National Institute of Drug Quality Control, Hanoi, Viet Nam; Medicines Control Authority, Control Laboratory of Zimbabwe, Harare, Zimbabwe.

Farmacopea Argentina, Buenos Aires, Argentina; Farmacopeia Brasileira, Brasilia, DF, Brazil; British Pharmacopoeia Commission, Medicines and Healthcare Products Regulatory Agency, London, England; Farmacopea Chilena, Valparaíso, Chile; Pharmacopoeia of the People's Republic of China, Beijing, People's Republic of China; Croatian Pharmacopoeia, Zagreb, Croatia; Czech Pharmacopoeia, Prague, Czech Republic; Danish Pharmacopoeia Commission, Copenhagen, Denmark; European Pharmacopoeia, European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France; Finnish Medicines Agency, Helsinki, Finland; Pharmacopée française, Agence nationale de sécurité du Médicament et des produits de santé, Saint-Denis, France; German Pharmacopoeia Commission, Bonn, Germany; Indian Pharmacopoeia Commission, Raj Nagar, Ghaziabad, India; Indonesian Pharmacopoeia Commission, Jakarta, Indonesia; Iranian Pharmacopoeia, Iranian Association of Pharmaceutical Scientists, Tehran, Islamic Republic of Iran; Committee of the Japanese Pharmacopoeia, Tokyo, Japan; Kazakhstan Pharmacopoeia, Pharmacopoeia Centre of the Republic of Kazakhastan, Almaty, Kazakhstan; Pharmacopoeia of the Republic of Korea, Cheongwon-gun, Chungbuk, Republic of Korea; Lithunian Pharmacopoeia Commission, Vilnius, Lithuania; Mexican Pharmacopoeia, México DF, Mexico; Philippines Pharmacopoeia, Manila, Philippines; Polish Pharmacopoeia Commission, Warsaw, Poland, Portuguese Pharmacopoeia, Lisbon, Portugal; State Pharmacopoeia of the Russian Federation, Moscow, Russian Federation; Serbian Pharmacopoeia, Belgrade, Serbia; Slovakian Pharmacopoeia Commission, Bratislava, Slovakia; Spanish Pharmacopoeia, Royal, Madrid, Spain; Swedish Pharmacopoeia, Uppsala, Sweden; Swiss Pharmacopoeia, Berne, Switzerland; Thai Pharmacopoeia, Nonthaburi, Thailand; Turkish Pharmacopoeia, Standards Department-Pharmacopoeia, Ministry of Health, General Directorate of Pharmaceuticals and Pharmacy, Ankara, Turkey; Pharmacopoeia of Ukraine, Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, Kharkov, Ukraine; United States Pharmacopeia, Rockville, MD, USA; Vietnamese Pharmacopoeia, Hanoi, Viet Nam.

WHO Centre Collaborateur pour la Conformité des Médicaments, Laboratoire national de Contrôle des Produits Pharmaceutiques, Alger, Algeria; WHO Collaborating Centre for Drug Quality Assurance, Therapeutic Goods Administration Laboratories, Woden, ACT, Australia; WHO Collaborating Centre for Drug Quality Assurance, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, People's Republic of China; WHO Collaborating Centre for Research on Bioequivalence Testing of Medicines, Frankfurt am Main, Germany; WHO Collaborating Centre for Drug Information and Quality Assurance, National Institute of Pharmacy, Budapest, Hungary; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Central Drugs Laboratory, Calcutta, India; WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, National Pharmaceutical Control Bureau, Jalan University, Ministry of Health, Petaling Jaya, Malaysia; WHO Collaborating Centre for Drug Quality Assurance, Pharmaceutical Laboratory, Centre for Analytical Science, Health Sciences Authority, Singapore; WHO Collaborating Centre for Quality Assurance of Drugs, North-West University, Potchefstroom, South Africa; WHO Collaborating Centre for Quality Assurance of Essential Drugs, Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.

Control of Neglected Tropical Diseases, WHO, Geneva, Switzerland; Essential Medicines and Health Products Department, WHO, Geneva, Switzerland; Global Malaria Programme, WHO, Geneva, Switzerland; Global TB Programme, WHO, Geneva, Switzerland; Health Systems and Innovation Cluster, WHO, Geneva, Switzerland; HIV/AIDS Programme, WHO, Geneva, Switzerland; Innovation, Access and Use, WHO, Geneva, Switzerland; Prequalification Team, WHO, Geneva, Switzerland; International Nonproprietary Names, WHO, Geneva, Switzerland; Office of the Legal Counsel, WHO, Geneva, Switzerland; Prevention of Noncommunicable Diseases, WHO, Geneva, Switzerland; Public Health, Innovation and Intellectual Property, WHO, Geneva, Switzerland; Prequalification Team, WHO, Switzerland; Regulation of Medicines and other Health Technologies, WHO, Geneva, Switzerland; Regulatory Systems Strengthening, WHO, Geneva, Switzerland; Safety and Vigilance Team, WHO, Geneva, Switzerland; Technologies Standards and Norms, WHO, Geneva, Switzerland; Traditional, Complementary and Integrative Medicine, WHO, Geneva, Switzerland; WHO Regional Office for Africa, Brazzaville, Congo; WHO Regional Office for the Americas/Pan American Health Organization, Washington, DC, USA; WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt; WHO Regional Office for Europe, Copenhagen, Denmark; WHO Regional Office for South-East Asia, New Delhi, India; WHO Regional Office for the Western Pacific, Manila, Philippines.

Abbott, Allschwil, Switzerland; Abbott Laboratories, Abbott Quality & Regulatory, Dept. 03QY, Abbott Park, IL, USA; Dr H. Abboud, Syria; Dr F. Abiodun, Benin City, Nigeria; Professor E. Adams, Laboratorium voor Farmaceutische Analyse, Leuven, Belgium; Dr M. Adarkwah-Yiadom, Standard Officer, Ghana Standards Board, Drugs, Cosmetics and Forensic Laboratory Testing Division, Accra, Ghana; Professor I. Addae-Mensah, Department of Chemistry, University of Ghana, Legon, Ghana; División de Química y Tecnología Farmacéutica, AEMPS, Madrid, Spain; Mrs U. Sonny-Afoekulu, GMP Inspectorate, National Regulatory Authority, Abuja, Nigeria; Dr K. Agravat, Regulatory Affairs, Unimark Remedies Limited, Ahmedabad, India; Ms R. Ahmad, Centre for Product Registration, National Pharmaceutical Control Bureau, Ministry of Health, Petaling Jaya, Malaysia; Dr S. Ahmed Jaffar, Director-General, Directorate General of Pharmaceutical Affairs and Drug Control, Ministry of Health, Muscat, Oman; Ajanta Pharma Ltd, Kandivli (West), Mumbai, India; Mr K.E. Al Anazi, Senior pharmacist, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Professor A. Al Kofahi, Member of the WHO Expert Advisory Panel on Traditional Medicine, Jordan University of Science and Technology, Irbid, Jordan; Dr N.J. Al Lawati, Director, Central Quality Laboratory, Ministry of Health, Oman, Muscat, Oman; Dr I. Aljuffali, Riyadh, Saudi Arabia; Professor A. Alkofahi, Member of the WHO Expert Advisory Panel on Traditional Medicine, Jordan University of Science and Technology, Irbid, Jordan; Dr B. Allen, Sr Director Global Quality Systems, Eli Lilly S.A. Irish Branch, Dunderrow, Kinsale, Co. Cork, Ireland; Dr N. Sh. Alothmany, Vice Executive President for Medical Devices Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Dr D. Alsmeyer, Apotex Inc., Toronto, Ontario, Canada; Amgen Inc., Engineering, West Greenwich, RI, USA; Mr A. Angole, National Regulatory Authority, Kampala, Uganda; Dr C. Anquez Traxler, European Self-Medication Industry, Brussels, Belgium; Dr P. Aprea, Director, Directorate of Evaluation and Control of Biologicals and Radiopharmaceuticals, National Administration of Medicines, Food and Medical Technology, Buenos Aires, Argentina; Dr N. Aquino, Inspector and Specialist in GMP and Risk Management, Brazilian Health Surveillance Agency, Brasilia, DF, Brazil; Dr A.C. Moreira Marino Araujo, Health Expert, Drugs Office, Post Approval Changes of Synthetic Drugs, Brazilian Health Surveillance Agency, Brasilia, DF, Brazil; Dr H. Arentsen, Regulatory Intelligence and Policy Specialist, Regulatory Development Strategy, H. Lundbeck A/S, Copenhagen-Valby, Denmark; Dr C. Arnés, Policy Analyst, Regulatory Policy and Economic Affairs, International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland; Dr A. Arya, San Francisco, CA, USA; Dr M. Owusu-Asante, Head, Drug Industrial Services Department, Food and Drugs Authority, Cantonments-Accra, Ghana; Professor G. Asghari, Chancellor, Isfahan University of Medical Sciences, Isfahan, Islamic Republic of Iran; Mr W.E. Asprec, Food-Drug Regulation Officer III, Senior Drug Evaluator, Manila, Philippines; Astellas Pharma Europe BV, Leiderdorp, Netherlands; Dr C. Athlan, Quality Reviewer, Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland; AstraZeneca, Global Regulatory Affairs, Patient Safety & Quality Assurance, Gaithersburg, MD, USA; Dr Au K.M.Q., Medical and Health Officer (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; Dr A. Ba, Directeur, Qualité et Développement, Centrale Humanitaire Medico-Pharmaceutique, Clermont-Ferrand, France; Mrs J.-V. Bacher, GMP Inspector, Institute Surveillance, Good Manufacturing Practice Department, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Vienna, Austria; Dr P. Baker, United States of America Food and Drug Administration, China Office, USA; Dr J.R. Ballinger, Guy's and St Thomas Hospital, London, England; Mr N. Banerjee, Cipla Limited, Goa, India; Dr R. Bate, American Enterprise Institute, Washington, D.C., USA; Dr H. Batista, US Food and Drug Administration, Silver Spring, MD, USA; Mr B. Baudrand, OTECI, Paris, France; Dr R. Bauer, Head of Institute, Institute Surveillance, Austrian Federal Office for Safety in Health Care, Austrian Agency for Health and Food Safety, Vienna, Austria; Dr O.P. Baula, Deputy Director, State Pharmacological Center, Ministry of Health, Kiev, Ukraine; Professor S.A.O. Bawazir, Riyadh, Saudi Arabia; Bayer Health Care Pharmaceuticals, Bayer Pharma AG, Berlin, Germany; Dr M.G. Beatrice, Vice President, Corporate Regulatory and Quality Science, Abbott, Abbott Park, IL, USA; Dr T.L. Bedane, Drug Administration and Control, Addis Ababa, Ethiopia; Ms T.J. Bell, WHO Focal Point, US Food and Drug Administration, Silver Spring, MD, USA; Dr M. Silvana Bellini, EDQM Laboratory, Strasbourg, France; Dr I.B.G. Bernstein, Director, Pharmacy Affairs, Office of the Commissioner/Office of Policy, US Food and Drug Administration, Silver Spring, MD, USA; Mr L. Besançon, General Secretary and CEO, International Pharmaceutical Federation, The Hague, Netherlands; Dr R.P. Best, President and CEO, International Society for Pharmaceutical Engineering, Tampa, FL, USA; Dr A. Bevilacqua, US Pharmacopeia, Bedford, MA, USA; Dr A.C. Bezerra Carvalho, Coordinator, Herbal and Homeopathic Medicines, General Office of Drugs, Brazilian Health Surveillance Agency, Brasilia DF, Brazil; Dr J. Bishop III, Review Management Staff, Office of the Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA; Dr F. Bland, Regulatory Affairs Manager, Global Regulatory and R&D Policy, Amgen, Thousand Oaks, CA, USA; Dr L. Bonthuys, Pretoria, South Africa; Mr M.H. Boon, Deputy Director, Overseas Audit Unit – Audit Branch, Audit & Licensing Division, Health Products Regulation Group, Singapore; Dr G. Born, Institute of Pharmaceutical Technology, Johann Wolfgang Goethe-University, Frankfurt, Germany; Professor R. Boudet-Dalbin, Paris, France; Dr B. Blum, Sandoz, France; Dr G. Bourdeau, Méréville, France; Dr S.K. Branch, Acting Group Manager, Special Populations Group, Medicines and Healthcare Products Regulatory Agency, London, England; Dr E. Brendel, Bayer HealthCare AG, Elberfeld, Germany; Dr M. Brits, Deputy Director, WHO Collaborating Centre for the Quality Assurance of Medicines, North-West University, Potchefstroom Campus, Potchefstroom, South Africa; Mr C. Brown, Inspections Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency, London, England; Dr W. Bukachi, Project Coordinator, International Affairs, US Pharmacopeia, Rockville, MD, USA; Ms A. Bukirwa, National (Food and) Drug Authority, Kampala, Uganda; Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Bundesministerium für Gesundheit, Berlin, Germany; Bundesministerium für Gesundheit, Bonn, Germany; Dr F. Burnett, Managing Director, Pharmaceutical Procurement Service, Organization of Eastern Caribbean States, Casties, St Lucia; Dr W. Cabri, Research and Development, Director, Chemistry and Analytical Development, Sigma-tau Industrie Farmaceutiche Riunite SpA, Pomezia, Italy; Dr M. Cahilly, Warren, Vermont, USA; Dr. D. Calam, Wiltshire, England; Dr N. Cappuccino, Dr Reddy's Laboratories, USA; Dr L. Cargill, Director, Caribbean Regional Drug Testing Laboratory, Kingston, Jamaica; Professor (Madame) R. Jiménez-Castellanos, Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Seville, Spain; Dr A. Castro, Regulatory Affairs Director and Senior Pharmacist, Roche Servicios SA, Heredia, Costa Rica; Dr D. Catsoulacos, Scientific Administrator, Manufacturing and Quality Compliance, Compliance and Inspection, European Medicines Agency, London, England; Mr J.-M. Caudron, Braine-le-Château, Belgium; Mr P. Cenizo, Southern African Pharmaceutical Regulatory Affairs Association (SAPRAA), Randburg, South Africa; Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA; Dr A.N.K. Chali, Chemical and Pharmaceutical Assessor, Uppsala, Sweden; Ms Chan B.F.P., Senior Pharmacist (Traditional Chinese Medicine), Public Health Laboratory Centre, Kowloon, Hong Kong SAR, China; Dr Chan K.H.A., Senior Medical and Health Officer (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; Mr X. Chan, Project Manager, International Pharmaceutical Federation, The Hague, Netherlands; Dr B. Chapart, Pharma Review Manager, Global Analytical Development, Sanofi-Aventis Pharma, Anthony, France; Ms S. Chatratana, Head, Thai Traditional Medicine and Herbal Medicine Section, Pre-marketing Control Division, Bureau of Drug Control, Food and Drug Administration, Ministry of Public Health, Nonthaburi, Thailand; Professor C.-T. Che, Norman R. Farnsworth Professor of Pharmacognosy, Department of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA; Ms Cheah Nuan Ping, Director, Cosmetics & Cigarette Testing Laboratory, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; Dr X. Chen, Director, Division of Drug Distribution Supervision, State Food and Drug Administration, Beijing, People's Republic of China; Professor Y. Cherrah, Faculté de Médecine et Pharmacie, Rabat, Morocco; Dr Cheung H.Y., Associate Professor, Department of Biomedical Sciences, City University of Hong Kong, Hong Kong SAR, China; Dr B.K. Choi, Director, Pharmaceutical Standardization, Osong Health Technology Administration Complex, Research and Testing Division of the Ministry of Food and Drug Safety, Cheongwon-gun, Chungbuk, Republic of Korea; Dr G. Choi, WHO Collaborating Centre for Traditional Medicine, Korea Institute of Oriental Medicine, Daejoen, Republic of Korea; Dr Y.H. Choi, Scientific Officer, Korea Food & Drug Administration, Cheongwon-gun, Chungbuk, Republic of Korea; Dr Chui K.Y., Senior Chemist (Pharmaceutical Quality and Investigation Section), Government Laboratory, Shatin, Hong Kong SAR, China; Mr D. Churchward, Expert GMDP Inspector, IE&S, Medicines and Healthcare products Regulatory Agency, London, England; Cipla Limited, Mumbai, India; Ms I. Clamou, Assistant Manager, Scientific,Technical and Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium; Dr A. Clark, Scientific Technical Writing Manager, Promoting the Quality of Medicines Program, US Pharmacopeial Convention, Rockville, MD, USA; Ms A. Cockrell, Deputy Executive Director, Society of Quality Assurance, Charlottesville, VA, USA; Dr M. Cooke, Senior Manager, Global Quality, Operations, AstraZeneca, Macclesfield, Cheshire, England; Mr P. Corbishley, Global Quality Manager, AstraZeneca, Macclesfield, Cheshire, England; Dr Ray Corrin, Special Access Program Advisor, Health Canada, Ottwa, Canada; Dr C. Craft, Member, United States Pharmacopeia International Health Expert Committee, Rockville, MD, USA; Dr T. Cundell, Microbiological Consulting, LLC., Scarsdale, NY, USA; Mrs Dam H. Huyen, Officer of Drug Business Administration Division, Drug Administration of Viet Nam, Hanoi, Viet Nam; Dr R.L. Dana, Senior Vice President, Regulatory Affairs and Parenteral Drug Association Training and Research Institute, Parenteral Drug Association, Bethesda, MD, USA; Mr M.M. Das, Barisha, Kolkata, India; Dr V. Davoust, Quality & Regulatory Policy, Pharmaceutical Sciences, Pfizer Global Research & Development, Paris, France; Professor V. De Feo, Department of Pharmaceutical Sciences, Faculty of Pharmacy, State University of Salerno, Fisciano, Italy; Dr H. de Jong, International Pharmaceutical Federation, The Hague, Netherlands; Dr D. de Kaste, National Institute for Public Health and the Environment, Bilthoven, Netherlands; Mr W.J.E. De Luna, Food-Drug Regulation Officer, Senior Drug Evaluator, Manila, Philippines; Professor T. Dekker, Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, South Africa; Dr M. Derecque-Pois, Director General, European Association of Pharmaceutical Full-line Wholesalers, Brussels, Belgium; Dr N. Sayeed-Desta, Apotex Inc., Toronto, Ontario, Canada; Dr S. Dey, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, New Delhi, India; Directorate General of Pharmaceutical Affairs and Drug Control, Ministry of Health, Muscat, Oman; Dr D. Diallo, Chief, Department of Traditional Medicine, Ministry of Health, Koulouba, Bamako, Mali; Mr J.L. Digón Huerta, AUDITS, Epatlan, Tijuana, Mexico; Dr R. Diyana, Senior Bioavailability/Bioequivalence Evaluator, National Authority for Food and Drug Control, Indonesia; Ms L. Donnelly, Regulatory Compliance Manager - Clinical Services, ALMAC, Craigavon, Northern Ireland; Dr P. Doerr, Head of Communication and Networking, Deputy Executive Director, Swissmedic, Basel, Switzerland; Dr C. dos Santos Nogueira, Especialista em Regulação e Vigilância Sanitária, ANVISA, Brasilia, Brazil; Professor J.B. Dressman, Director, Institut für Pharmazeutische Technologie, Biozentrum, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany; Mrs S. Dube-Mwedzi, Consultant Regulatory Officer, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Dr A.T. Ducca, Senior Director, Regulatory Affairs, Healthcare Distribution Management Association, Arlington, VA, USA; Dr T.D. Duffy, Lowden International, Tunstall, Richmond, N. Yorks, England; Dr S. Durand-Stamatiadis, Director, Information and Communication, World Self-Medication Industry, Nyon, Switzerland; Dutch Health Care Inspectorate, Heerlen, Netherlands; Dr M. Edrees Ahmed, Pharmaceutical Factories Inspector, Central Administration of Pharmaceutical Affairs, Ministry of Health, Cairo, Egypt; Dr P. Ellis, Director, External Advocacy, Quality Centre of Excellence, GlaxoSmithKline, Brentford, Middlesex, England; Dr J. Ermer, Head of Quality Control Services Frankfurt Chemistry, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany; European Compliance Academy Foundation, Heidelberg, Germany; European Compliance Academy, Mannheim, Germany; Fedefarma, Ciudad, Guatemala; F. Hoffman-La Roche Ltd, Basel, Switzerland; Dr A. Falodun, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Benin, Benin City, Nigeria; Federal Ministry of Health, Bonn, Germany; Mr J. Fang, Deputy Director, Guangdong Provincial Institute for Drug Control, Guangzhou, Guangdong, China; Dr E. Fefer, Member, United States Pharmacopeia International Health Expert Committee, Rockville, MD, USA; Dr R. Fendt, Head, Global Regulatory & GMP Compliance Pharma, Care Chemicals Division, BASF, Limburgerhof, Germany; Dr Feng Y.B., Associate Professor, Assistant Director (Education), School of Chinese Medicine, The University of Hong Kong, Hong Kong, Hong Kong SAR, China; Dr F. Fernández, Georgia Institute of Technology, Atlanta, Georgia, USA; Mr A. Ferreira do Nascimento, Agência Nacional de Vigilância, Brasília, Brazil; Mr M. FitzGerald, European Association of Pharmaceutical Full-line Wholesalers, Brussels, Belgium; Mr H. Flechl, Vienna, Austria; Dr A. Flueckiger, Head, Corporate Health Protection, Corporate Safety, Health & Environmental Protection, F. Hoffmann-La Roche, Basel, Switzerland; Professor H. Fong, Professor emeritus, University of Illinois at Chicago, Chicago, Illinois, USA; Dr G.L. France, Head, Q&A Compliance, EU Region, Novartis Consumer Health Services SA, Nyon, Switzerland; Dr A. Fuglsang, Haderslev, Denmark; Mr T. Fujino, Director, International Affairs, Japan Generic Medicines Association, Tokyo, Japan; Mr A. García Arieta, Spanish Agency of Medicines and Medical Devices, Madrid, Spain; Dr T. Garrett, Head of Office, Office of Complementary Medicines, Therapeutic Goods Administration, Department of Health, Woden, ACT, Australia; Miss Y. Gao, Project Manager, Chinese Pharmacopoeia Commission, Beijing, People's Republic of China; Dr A. Garcia, Head of Service on Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Agencia Española de Medicamentos y Productos Sanitarias, Madrid, Spain; Dr M. Garvin, Senior Director, Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America, Washington, DC, USA; Dr A. Gayot, Faculté de Pharmacie de Lille, Lille, France; Dr X. Ge, Senior Analytical Scientist, Pharmaceutical Laboratory, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; German Expert Group on Computerised Systems, Bonn, Germany; Dr L. Gibril, Compliance Coordinator, Novartis Pharma SAE, Amiria, Cairo, Egypt; Gilead Sciences International Ltd, Abington, Cambridge, England; Professor A. Gimenez Turba, Instituto de Investigaciones Farmaco Bioquimicas, Universidad Mayor de San Andrés, La Paz, Bolivia; Dr F. Giorgi, Research and Development, Analytical Development Manager, Sigma-tau Industrie Farmaceutiche Riunite SpA, Pomezia, Italy; Dr L. Girard, Head, Global Pharmacopoeial Affairs, Novartis Group Quality, Quality Systems and Standards, Basel, Switzerland; GlaxoSmithKline, Brentford, Middlesex, England; GlaxoSmithKline Biologicals SA, Wavre, Belgium; GlaxoSmithKline, Research Triangle Park, NC, USA; Glówny Inspektorat Farmaceutyczny, Warsaw, Poland; Dr C. Horta Gomes, Office of International Affairs, Brazilian Health Regulatory Agency – ANVISA, Rio de Janeiro, Brazil; Dr C. Sánchez González, Coordinator of Policies and Regulatory Affairs Centro para el Control de Medicamentos, Equipos y Dispositivos Médicos, La Habana, Cuba; Dr J. Gordon, Wolfville, Nova Scotia, Canada; Dr A. Gould, Mt Eliza, Victoria, Australia; Dr M. Goverde, QC Expert Microbiology, Novartis Pharma AG, Basel, Switzerland; Ms R.Govithavatangaphong, Director, Bureau of Drug and Narcotics, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr L. Graham, Medicines & Healthcare products Regulatory Agency, London,England; Dr J. Grande, Manager, Regulatory Affairs, McNeil Consumer Healthcare, Markham, England; Dr A. Gray, Senior Lecturer, Department of Therapeutics and Medicines Management and Consultant Pharmacist, Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; Dr M. Green, Division of Parasitic Diseases, CDC, Atlanta, Georgia, USA; Dr M. Guazzaroni Jacobs, Director, Quality and Regulatory Policy, Pfizer Inc., New York, NY, USA; Dr P. Guerin, WorldWide Antimalarial Resistance Network, Oxford University, England; Ms N.M. Guerrero, Radiofarmacia de Centroamérica, SA, Ciudad del Saber, Panamá, Panama; Guilin Pharmaceutical Company Ltd, Guilin, People's Republic of China; Dr R. Guinet, Agence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France; Dr S. Gupta, Mankind Pharma Limited, Unit-II, Vill. Kishanpura, Paonta Sahib, Disst. Sirmour, India; Professor R. Guy, Professor of Pharmaceutical Sciences, Department of Pharmacy & Pharmacology, University of Bath, Bath, England; Dr M. Guzzetti, Global Leader Anti-Counterfeit Medicines, Business Operation Manager C&P Switzerland, Intertek Life Sciences, Basle, Switzerland; Mr L. Gwaza, Medicines Regulation, Evaluations & Registration Division, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Dr N. Habib, Director General of Medical Supplies, Ministry of Health, Oman; Dr S. Haidar, Acting Director, Division of Generic Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Dr M. Haidara, National Research Institute of Public Health (INRSP), Ministry of Health and Public Hygiene, Bamako, Mali; Dr T. Hakamatsuka, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences, Ministry of Health, Labour and Welfare, Kamiyoga, Setagaya-ku, Tokyo, Japan; Dr N. Hamilton, Industrial Quality and Compliance, Industrial Affairs, Sanofi Aventis, West Malling, Kent, England; Ms J. Hantzinikolas, Therapeutic Goods Administration, Department of Health, Woden, ACT, Australia; Dr K. Hara, Principal GMP Inspector, Office of Manufacturing/Quality and Compliance, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Dr S. Harada, International Affairs Division, Minister's Secretariat, Ministry of Health, Labour and Welfare, Tokyo, Japan; Dr P. Hargreaves, Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency, London, England; Dr B. Hasselbalch, Acting Associate Director, Policy and Communications, and Director, Division of Policy, Collaboration & Data Operations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA; Dr A. Hawwa, Lecturer in Pharmacy (Medicines in Children), Medical Biology Centre, Queen's University Belfast, Belfast, Northern Ireland; Dr M. Hayes-Bachmeyer, Technical Regulatory Affairs, Pharmaceuticals Division, F. Hoffmann-la Roche, Basel, Switzerland; Dr Y. He, Research Fellow, Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes of Food and Drug Control, China Food and Drug Administration (CFDA), Beijing, China; Mr Y. Hebron, Manager, Medicines and Cosmetics Analysis Department, Tanzania Food and Drugs Authority, Dar-es-Salaam, United Republic of Tanzania; Dr G.W. Heddell, Director, Inspection Enforcement & Standards Division, Medicines and Healthcare Products Regulatory Agency, London, England; Dr D. Hege-Voelksen, Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland; Dr M. Hetzel, Swiss Tropical and Public Health Institute, Switzerland; Ms J. Hiep, QA Pharmacist and Auditor, Adcock Ingram, Bryanston, South Africa; Ms M. Hirschhorn, Head, Quality and Chemistry Sector, Comisión para el Control de Calidad de Medicamentos (Drug and Control Commission), Montevideo, Uruguay; Mr S.C. Hock, Senior Consultant (Audit & Licensing) & Director (Quality Assurance), Health Sciences Authority of Singapore, Singapore; Mrs L. Hong, Senior Pharmacist and Director of Zhejiang Provincial Institutes for Food and Drug Control, Hangzhou, People's Republic of China; Mrs J. Hong, Senior Pharmacist and Director of Hubei Provincial Institutes for Food and Drug Control, Wuhan Hubei, People's Republic of China; Professor J. Hoogmartens, Leuven, Belgium; Dr K. Hoppu, Director, Poison Information Centre, Helsinki University Central Hospital, Helsinki, Finland; Dr K. Horn, Managing Director, Institute for Pharmaceutical and Applied Analytics, Official Medicines Control Laboratory, Bremen, Germany; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Dr H. Hoseh, Head of Registration Unit, Drug Directorate, Jordan Food and Drug Administration, Jordan; Dr X. Hou, Chemical & Materials, Singapore; Dr N. Ibrahim, National Pharmaceutical Control Bureau, Ministry of Health, Jalan University, Petaling Jaya, Indonesia; In-ADME Research, New York, NY, USA; Indian Drug Manufacturers' Association, Mumbai, India; Infarmed, Lisbon, Portugal; INS, Peru; Intas Pharmaceuticals Ltd, Matoda, Ahmedabad, India; Mr P. Intarapanich, Pharmacist, Senior Professional Level, The Inspectorate Unit, Division of Post-marketing Control, Bureau of Drug Control, Food and Drug Administration, Ministry of Public Health, Nonthaburi, Thailand; Ipsen Pharma, Dreux, France; Dr S.P. Ip, Research Fellow, School of Chinese Medicine, The Chinese University of Hong Kong, Hong Kong Institute of Biotechnology Limited, Shatin, Hong Kong SAR, China; Dr J. Isasi Rocas, Pharmaceutical Chemist, Lima, Peru; ISPE, USA; Dr M. Ito, Chair, International Pharmaceutical Federation, Special Interest Group on Natural Products, Graduate School of Pharmaceutical Sciences, Kyoto University, Japan; Professor R. Jachowicz, Head, Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Faculty of Pharmacy, Kraków, Poland; Mr I. Jackson, Operations Manager, GMDP Inspections, Inspection, Enforcement & Standards Division, Medicines and Healthcare Products Regulatory Agency, London, England; Dr M. Guazzaroni Jacobs, Director Quality and Regulatory Policy, Pfizer, New York, NY, USA; Dr S.A. Jaffar, Director General, Pharmaceutical Affairs and Drug Control, Ministry of Health, Muscat, Oman; Johnson & Johnson, Latina, Italy; Dr R. Jähnke, Global Pharma Health Fund e.V., Frankfurt, Germany; Dr S. Jaiswal, Macleods Pharmaceuticals Mumbai, India; Dr M. James, GlaxoSmithKline, Brentford, Middlesex, England; Dr A. Janssen, Manager, Regulatory Affairs, DMV Fonterra Excipients, FrieslandCampina Ingredients Innovation, Goch, Germany; Dr Y. Jiang, Director, Guangzhou Municipal Institute for Drug Control, Guangzhou, China; Dr J. Jianhui, Center for Drug Evaluation, Chinese Food and Drug Administration, Beijing, China; Professor S. Jin, Chief Expert for Pharmaceutical Products, National Institutes for Food and Drug Control, Beijing, People's Republic of China; Johnson & Johnson, Beerse, Belgium; Johnson & Johnson, Fort Washington, PA, USA; Dr P. Jones, Director, Analytical Control, Pharmaceutical Sciences, Pfizer Global R&D, Sandwich, England; Dr J.-L. Jouve, La Chapelle sous Aubenas, France; Dr Y. Juillet, Consultant, Paris, France; Mr D. Jünemann, Teaching Assistant; Institut für Pharmazeutische Technologie, Biozentrum, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany; Ms A. Junttonen, Senior Pharmaceutical Inspector, National Agency for Medicines, Helsinki, Finland; Dr S. Kafkala, Analytical Development Director, Genepharm S.A., Pallini, Greece; Dr V. Kamde, Quality Management, Oman Pharmaceuticals, Oman; Dr M. Kaplan, Director, Institute for Standardization and Control of Pharmaceuticals, Jerusalem, Israel; Dr M. Karga-Hinds, Director, Barbados Drug Service, Christchurch, Barbados; Mr H. Kawakita, Office of Manufacturing/Quality and Compliance, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Dr A.M. Kaukonen, National Agency for Medicines, Helsinki, Finland; Dr H. Kaur, London School of Hygiene and Tropical Medicine, England; Ms H. Kavale, Cipla, Mumbai, India; Dr S. Kawade, Mylan Laboratories Limited, Bengaluru, India; Dr T. Kawanishi, Deputy Director General, National Institute of Health Sciences, Tokyo, Japan; Dr S. Keitel, Director, European Directorate for the Quality of Medicines and Healthcare, Strasbourg, France; Dr K. Keller, Director and Professor, Federal Ministry of Health, Bonn, Germany; Dr M. Keller, Inspector, Division of Certificates and Licencing, Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland; Dr L. Kerr, Scientific Operations Adviser, Office of Laboratories and Scientific Services, Therapeutic Goods Administration, Woden, ACT, Australia; Dr M. Khan, Director, Federal Research Center Life Sciences, US Food and Drug Administration, Silver Spring, MD, USA; Dr S. Khoja, Vapi, Gujarat, India; Dr A.S. Kijo, Tanzania Food and Drugs Authority, Dar es Salaam, United Republic of Tanzania; Mrs K. Kikule, Head, Drug Inspectorate Services, National Drug Authority, Kampala, Uganda; Dr J.Y. Kim (Deputy Director), Ministry of Food and Drug Safety (MFDS), Seoul, Republic of Korea; Professor Y.S. Kim, Director of the WHO Collaborating Centre for Traditional Medicine, Natural Products Research Institute, College of Pharmacy, Seoul National University, Gwanakgu, Republic of Korea; Professor K. Kimura, Drug Management and Policy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa-city, Japan; Ms M. Kira, Consultant, Non-Governmental Organizations and Industry Relations Section, Department of External Relations, World Intellectual Property Organization, Geneva, Switzerland; Dr W. Knöss, Head, Department Complementary and Alternative Medicines and Traditional Medicines, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Dr W. Kongsuk, Bureau of Drug and Narcotic, Department of Medical Sciences, Nonthaburi, Thailand; Dr H. Köszegi-Szalai, Head, Department for Quality Assessment and Control, National Institute of Pharmacy, Budapest, Hungary; Dr A. Kovacs, Secretariat, Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; Ms S. Kox, Senior Director Scientific Affairs, European Generic Medicines Association, Brussels, Belgium; Dr P. Kozarewicz, Scientific Administrator, Quality of Medicines Sector, Human Unit Pre-Authorization, European Medicines Agency, London, England; Dr A. Krauss, Principal Chemist, Office of Laboratories and Scientific Services, Therapeutic Goods Administration, Woden, ACT, Australia; Professor H.G. Kristensen, Vedbaek, Denmark; Dr B.H. Kroes, Senior Regulatory Project Leader, Assessor, Section Botanicals and Novel Foods, Medicines Evaluation Board, Utrecht, Netherlands; Dr J. Kumar, HLL Lifecare Ltd., Kanagala, Belgaum, India; Dr S. Kumar, Assistant Director, National Medicinal Plant Board, Ministry of Health and Family Welfare, New Delhi, India; Mr A. Kupferman, Bangkok, Thailand; Dr S. Kumar, Assistant Drugs Controller, Central Drugs Standard Control Organization, Food and Drug Administration Bhawan, New Delhi, India; Dr W. Kwiringira, National Drug Quality Control laboratory, National Drug Authority, Kampala, Uganda; Professor S. Läer, Institut für Klinische Pharmazie und Pharmakotherapie, Heinrich-Heine-Universität, Düsseldorf, Germany; Dr Lam M.K.R., Director of the WHO Collaborating Centre for Traditional Medicine and Assistant Director (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; Mr Law K.W.R., Senior Pharmacist (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; Dr O. Le Blaye, Inspector, Trials and Vigilance Inspection Department, Agence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France; Dr S.J. Lee, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, and Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, England; Dr R. Lehnert, Clinical Assessor, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Mr N.D. Lenegan, Managing Director, ISPE HVAC Subject Matter Expert & Training Instructor, Energy & Carbon Reduction Solutions, Mossley, Ashton-Under-Lyne, Lancashire, England; Dr F.-X. Lery, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France; Dr B. Li, Deputy Director General, National Institutes for Food and Drug Control, Ministry of Public Health, Beijing, People's Republic of China; Dr H. Li, Head, Chemical Products Division, Chinese Pharmacopoeia Commission, Beijing, People's Republic of China; Miss L. Li, Chief Pharmacist and Director, Xiamen Institute for Food and Drug Control, Xiamen Coastal Institute for Drug Control, Xiamen, Fujian, People's Republic of China; Dr X. Li, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Dongzhimen Nei, Beijing, China; Dr C.M. Limoli, Senior International Health Advisor, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA; Ms D.W. Lo, Chinese Medicine Practitioner, TCM Lifestyle Clinic, Hong Kong SAR, China; Dr A. Lodi, Head, Laboratory Department, European Directorate for the Quality of Medicines and HealthCare, Strasbourg, France; Mr M. Lok, Head of Office, Office of Manufacturing Quality, Therapeutic Goods Administration, Woden, ACT, Australia; Dr J. Lotter, Medicines Control Council, Pretoria, South Africa; Ms M.Y. Low, Director, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; Dr K. Lucas, Sr Manager, Stability Sciences, Pharm Quality Stability Operations, Janssen Pharmaceuticals Inc., Raritan, NJ, USA; Dr I. Lucas-Manzano, International Pharmacist Coordinator, Médecins Sans Frontières International Office, Geneva, Switzerland; Mr R. Luigetti, European Medicines Agency, London, England; Lupin Ltd, Mumbai, Maharashtra, India; Dr J.C. Lyda, Senior Director, Regulatory Affairs, Parenteral Drug Association Europe, Glienicke/ Berlin, Germany; Mr D. Mader, Compliance Auditor, GlaxoSmithKline, Cape Town, South Africa; Dr C. Makokha, Kikuyu, Kenya; Ms G.N. Mahlangu, Director-General, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Dr J.-D. Mallet, Paris, France; Ms L.J. Mamvura, Chemistry Division, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Ms Man P.M.M., Scientific Officer (Medical), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; Mangalam Drugs and Organics Limited, Mumbai, India; Dr M.A. Mantri, Bicholim, Goa, India; Martindale Pharma, Brentwood, Essex, England; Dr R. Marini Djang'eing'a, Pharmacy Department, University of Liège, Liège, Belgium; Dr J.Y. Martey, Accra, Ghana; Dr A.C. Moreira Marino Araújo, Brazilian Health Surveillance Agency, Brasilia, Brazil; Dr B. Matthews, Alcon, Hemel Hempstead, England; Dr Y. Matthews, Regulatory Operations Executive, GE Healthcare, Amersham, Bucks, England; Dr S.V.M. Mattos, Especialista em Regulação de Vigilância Sanitária, Coordenação da Farmacopeia Brasileira, Brazilian Health Surveillance Agency, Brasília, Brazil; Mr S. Matviienko, Kyiv, Ukraine; Dr S. May, Director of Public Outreach, American Association of Pharmaceutical Scientists, Arlington, VA, USA; Dr M. Mayxay, Laos–Oxford, Mahosot Hospital – Wellcome Trust Unit, Vientiane, Lao People's Democratic Republic; Dr J.L. Mazert, France; Dr G. McGurk, Executive Inspector, Irish Medicines Board, Dublin, Ireland; Dr A. Mechkovski, Moscow, Russian Federation; Medicines and Healthcare Products Regulatory Agency, London, England; Medopharm, Chennai, Tamilnadu, India; Dr M. Mehmandoust, Agence nationale de sécurité du médicament et des produits de santé, Saint-Denis, France; Dr D. Mehta, Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, England; Merck Group, France; Merck and Co., Inc., Silver Spring, MD, USA; Dr K. Mettke, Good Clinical Practices Inspector, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Micro Labs Ltd, Kilpauk, Chennai, India; Dr M. Mikhail, Fresenius Kabi, Bad-Homburg, Germany; Dr J.H.McB. Miller, Ayr, Scotland; Dr O. Milling, Medicines Inspector, Medicines Control Division, Danish Medicines Agency, Copenhagen, Denmark; Dr S. Mills, Pharmaceutical Consultant, Ware, England; Ministry of Health, Kuala Lumpur, Malaysia; Ministry of Health, Government of Pakistan, Islamabad, Pakistan; Ministry of Health, Labour and Welfare, Tokyo, Japan; Dr J. Mitchell, GlaxoSmithKline, Belgium; Dr C. Mizumaru, JP Secretariat, Division of Pharmacopoeia and Standards for Drugs, Office of Standards and Guidelines Development, Tokyo, Japan; Dr S. Moglate, United Nations Population Fund, UN City, Copenhagen, Denmark; Dr N. binti Mohamad Zainoor, Head, Pharmaceutical Chemistry Section, Centre for Quality Control, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan Universiti, Petaling Jaya, Selangor, Malaysia; Dr S. Mohapatra, Mylan Laboratories Limited, Bengaluru, India; Dr N.H. Mohd, Director General of Medical Supplies, Ministry of Health, Muscat, Oman; Pharmaceutical Affairs & Drug Control, Ministry of Health, Muscat, Oman; Ms N.H. Mohd Potri, Senior Assistant, Director, GMP and Licensing Division, Centre for Compliance and Licensing, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Petaling Jaya, Malaysia; Dr J.A. Molzon, Bethesda, MD, USA; Dr I. Moore, Product and Quality Assurance Manager, Croda Europe, Snaith, England; Dr K. Moore, Manager, Pharmacopeial Harmonization, United States Pharmacopeia, Rockville, MD, USA; Dr J. Morénas, Assistant Director, Inspection and Companies Department, Agence nationale de sécurité du médicament et des produits de santé, Saint Denis, France; Dr C. de la Morena Criado, Spanish Agency of Medicines and Medical Devices, Madrid, Spain; Dr J.M. Morris, Irish Medicines Board, Dublin, Ireland; Mr T. Moser, Galenica, Berne, Switzerland; Dr G.P. Moss, Redhill, Surrey, England; Dr A.E. Muhairwe, Executive Secretary and Registrar, National Drug Authority, Kampala, Uganda; Dr. S. Mülbach, Director, Senior Regulatory Counsellor, Vifor Pharma, Glattbrugg, Switzerland; Mr D.T. Mwangomo, Drug Registration Officer, Tanzania Food and Drug Authority, Dar Es Salaam, United Republic of Tanzania; Mylan Laboratories Limited, Drug Regulatory Affairs, Jinnaram Mandal, Andhra Pradesh, India; Dr M.S. Najjar, Amman, Jordan; Ms N. Nan, Chief Pharmacist, National Institutes for Food and Drug Control, Beijing, People's Republic of China; Miss X. Nan, Project Officer, China Center for Pharmaceutical International Exchange, Beijing, People's Republic of China; Dr E. Narciandi, Head, Technology Transfer Department, Center for Genetic Engineering & Biotechnology, Havana, Cuba; National Agency of Drug and Food Control, Jakarta Pusat, Indonesia; National Authority of Medicines and Health Products, Directorate for the Evaluation of Medicinal Products, Lisbon, Portugal; National Institute of Drug Quality Control of Vietnam, Hanoi, Viet Nam; Professor G.E. Navas T., Facultad de Farmacia, Universidad de Panamá, Panamá, Panama; NBCD Working Group, Leiden, Netherlands; Dr R. Neri, Sanofi, Antony, France; Dr J. Netterville, Associate Director, Global Regulatory Intelligence, Global Regulatory Affairs, Patient Safety & Quality Assurance, AstraZeneca, Gaithersburg, MD, USA; Dr P.N. Newton, Worldwide Antimalarial Resistance Network, Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, England; Dr K.L. Ng, Chief, Department of Hospital Administration, Conde S. Januario General Hospital, Health Bureau, Macao SAR Government, Macao SAR, China; Ms T.H.M. Ngo, Deputy Director of Drug Information and Advertising Management Division, Drug Administration of Viet Nam, Hanoi, Viet Nam; Professor B. Ning, Deputy Chief, Division of Chemical Drugs, National Institutes for Food and Drug Control, Beijing, China; Dr I.K.L. Ng, Chief, Division of Pharmacovigilance and Pharmacoeconomics, Department of Pharmaceutical Affairs, Health Bureau, Macao SAR Government, Macao SAR, China; Ms Ngan M.S.T., Senior Pharmacist, Hospital Authority Head Office, Pamela Youde Nethersole Eastern Hospital, Hong Kong, Hong Kong SAR, China; Dr E. Nickličková, Inspector, State Institute for Drug Control, Prague, Czech Republic; Professor A. Nicolas, Paris, France; Dr H.K. Nielsen, Technical Specialist, Essential Medicines, Medicines and Nutrition Centre, UNICEF Supply Division, Copenhagen, Denmark; Professor B. Ning, Deputy Director, Division of Chemical Drugs, National Institutes for Food and Drug Control, Beijing, People's Republic of China; Dr S. Ning, Mississauga, Ontario, Canada; Dr P. Njaria, Head, Quality Assurance Unit and Instrumentation, National Quality Control Laboratory, Nairobi, Kenya; Dr K. Nodop, Inspections, European Medicines Agency, London, England; Novartis Group Quality, Novartis Campus, Basel, Switzerland; Dr A. Nolting, Clinical Review, Swissmedic, Bern, Switzerland; Mr M.N. bin M. Noor, Head of GMP 2 Section, Center for Compliance and Licensing, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Jalan Universiti, Petaling Jaya, Selangor, Malaysia; Professor A. Nunn, Formby, Liverpool, England; Dr A. Nyika, Senior Regulatory Officer-GMP Inspections, Licensing & Enforcement Division, General Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Mr D. Obradovich, Regulatory Project Manager, Abbott Quality and Regulatory, Abbott, Abbott Park, IL, USA; Dr H. Okuda, Deputy Director General of National Institute of Health Sciences, Tokyo, Japan; Mrs A. Ojoo, Technical Specialist, Paediatric Formulations, UNICEF Supply Division, Nordhavn, Copenhagen, Denmark; Mr S. O'Neill, Managing Director, The Compliance Group, Dublin, Ireland; Dr L. Oresic, Head, Quality Assurance Department, Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Dr P.B. Orhii, Director-General, National Agency for Food and Drug Administration and Control, Abuja, Nigeria; Dr N. Orphanos, International Programs Division, Bureau of Policy, Science, and International Programs, Therapeutic Products Directorate, Health Products & Food Branch, Health Canada, Ottawa, Canada; Dr. S. S. Ozdem, Head, Department of Medical Pharmacology, Akdeniz University Medical Faculty, Head of Department, Antalya, Turkey; Professor T.L. Paál, Professor emeritus, Institute of Drug Regulatory Affairs, University of Szeged, and Scientific Advisor, National Institute of Pharmacy and Nutrition, Budapest, Hungary; Dr P.R. Pabrai, New Delhi, India; Dr R. Pai, Johannesburg, South Africa; Mrs L. Paleshnuik, Arnprior, Ontario, Canada; Dr D. Paliwal, Paonta Sahaib, India; Dr M. Parker, Ethox Centre, Oxford University, England; Dr S. Parra, Manager, Generic Drugs Quality Division 1, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada; Dr Barbara Passek, Fachapothekerin für öffentliches Gesundheitswesen, Bundesministerium für Gesundheit, Bonn, Germany; Dr D.B. Patel, Secretary-General, Indian Drug Manufacturers' Association, Mumbai, India; : Dr. D.D. Patil, Pharmez, Sarkhej-Bavla, Ahmedabad, Gujarat, India; Dr P.S. Patil, Umedica Laboratories Pvt. Ltd, Vapi, Gujarat, India; Dr S.R. Srinivas Patnala, Grahamstown, South Africa; Professor S. Patnala, Pharmaceutical Analysis and Coordinator, University Instrumentation Facility, KLE University, Belgaum, India; Dr A. Pazhayattil, Apotex Inc., Toronto, Ontario, Canada; Dr J.P.S. Perfeito, Manager, Herbal Medicines, General Office of Drugs, Brazilian National Health Surveillance Agency, Brasília, Brazil; Dr G. Penzlin, Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany; Mr C. Perrin, Pharmacist, International Union Against Tuberculosis and Lung Disease, Paris, France; Dr M. Phadke, Senior Manager, Analytical Research, IPCA Laboratories, Mumbai, India; Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; Dr S. Phanouvong, United States Pharmacopeia, Rockville, MD, USA; Dr B. Phillips, Medicines and Healthcare Products Regulatory Agency, London, England; Ms S.S. Phyo, Staff Officer, Research and Development Division, Department of Traditional Medicine, Ministry of Health and Sports, Naypyitaw, Myanmar; Dr R.D. Pickett, Supanet, Bucks, England; Dr B. Pimentel, European Chemical Industry Council, Brussels, Belgium; Polychromix, Inc., Wilmington, MA, USA; Dr A. Pontén-Engelhardt, Head of Stability Management, Global Quality, Operations, AstraZeneca, Södertälje, Sweden; Ms A. Poompanich, Bangkok, Thailand; Dr H. Potthast, Federal Institute for Drugs and Medical Devices, Berlin, Germany; Dr R. Prabhu, Regulatory Affairs Department, Cipla, Mumbai, India; Dr J. Prakash, Sr Principal Scientific Officer, Indian Pharmacopoeia Commission, Raj Najar, Ghaziabad, India; Dr P.B.N. Prasad, Deputy Drugs Controller (India), CDSCO, Zonal Office, Hyderabad, CDSCO Bhavan, Hyderabad, Andhra Pradesh, India; Dr R.P. Prasad, Director, Department of Drug Administration, Kathmandu, Nepal; Ms S.J. Putter, Walmer, Port Elizabeth, South Africa; Quality Systems and Standards – Group Quality, Novartis Pharma AG, Basel, Switzerland; Dr A. Raal, Docent of Pharmacognosy, Head of the Chair of Pharmacognosy and Pharmaceutical Management, Institute of Pharmacy, University of Tartu, Tartu, Estonia; Rabat Institute, National Laboratory of Medicine Control, Rabat, Morocco; Dr M. Rafi, Assistant Manager (Regulatory Affairs), HLL Lifecare Limited, Belgaum, Karnataka, India; Dr L. Rägo, Geneva, Switzerland; Dr A. Rajan, Director, Celogen Lifescience & Technologies, Mumbai, India; Mr T.L. Rauber, Specialist in Health Surveillance, Agência Nacional de Vigilância Sanitária Agency, Brasilia, Brazil; Dr R. Ravinetto, Institute of Tropical Medicine Antwerp, Belgium; Mr N. Raw, Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency, London, England; Mr N. Rech, Brazilian Pharmacopoeia, Brazilian Health Surveillance Agency, Brasilia, DF, Brazil; Mr K. Reh, Deputy Head of Division, Department Complementary and Alternative Medicines and Traditional Medicines, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Dr J.-L. Robert, Luxembourg; Dr J. Robertson, St Albans, England; Dr S. Rönninger, Global Quality Manager, F. Hoffmann-La Roche, Basel, Switzerland; Dr J. Isasi Rosas, CNCC, Chorrillos, Lima, Peru; Dr N. Ruangrittinon, Bureau of Drug and Narcotic Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; Dr L.A. Sotelo Ruiz, Comisión de Control Analítico y Ampliación de Cobertura, Tlalpan, Distrito Federal, Mexico; Rusan Pharma Ltd, Selaqui, Dehradun, India; Dr J. Sabartova, Prague, Czech Republic; Dr P.L. Sahu, Indian Pharmacopoeia Commission, Raj Nagar, Ghaziabad, Uttar Pradesh, India; Dr A. Saint-Raymond, Head of Programme Board, Skills and Expertise, European Medicines Agency, London, England; Dr E.I. Sakanyan, Director, Centre of the Pharmacopoeia and International Collaboration, Federal State Budgetary Institution, Scientific Centre for Expert Evaluation of Medicinal Products, Moscow, Russian Federation; Professor G. Saltan, Faculty of Pharmacy, Department of Pharmacognosy, Ankara University, Ankara, Turkey; Dr A.P. Sam, Merck, Netherlands; Dr C. Sánchez González, Adviser, Centre para el Control de Medicamentos, Equipos y Dispositivos Médicos, Havana, Cuba; Dr E. Moya Sánchez, Radiofarmaceutica-Evaluadora de Calidad, División de Química y Tecnología Farmacéutica, Departamento de Medicamentos de Uso Umano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain; Sanofi, Gentilly, France; Sanofi, Bridgewater, NJ, USA; Sanofi Aventis, Antony, France; Dr G. Mendes Lima Santos, Coordinator of Therapeutic Equivalence, Brazilian Health Surveillance Agency, Brasilia, DF, Brazil; Dr L.M. Santos, Scientific Liaison – International Health, The United States Pharmacopeia, Rockville, MD, USA; Dr B. Santoso, Yogyakarta, Indonesia; Sanum-Kehlbeck GmbH & Co. KG, Germany; Dr T. Sasaki, Pharmaceutical and Medical Devices Agency, Tokyo, Japan; Professor M. Satake, Medicinal Plant Resources Research, Medicinal Plant Garden, Showa Pharmaceutical University, Machida, Tokyo, Japan; Dr J. Satanarayana, Matrix Laboratories, Secunderabad, India; Dr D. Sato, Director, Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan; Dr G. Saxena, Unit Head, Product Assessment Division, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Ontario, Canada; Dr B. Schmauser, Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany; Dr A. Schuchmann, Brazil; Professor G.K.E. Scriba, Professor for Pharmaceutical Chemistry, Friedrich-Schiller-University Jena, Department of Pharmaceutical Chemistry, Jena, Germany; Dr I. Seekkuarachchi, Project Manager, Takeda Pharmaceutical Co., Osaka, Japan; Dr A. Seiter, Member, United States Pharmacopeia International Health Expert Committee, Rockville, MD, USA; Ms K. Sempf, Teaching Assistant, Institut für Pharmazeutische Technologie, Biozentrum, Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany; Servicio de Especialidades Medicinales del Instituto Nacional de Medicamentos, Service of Pharmaceutical Products, Buenos Aires, Argentina; Dr U. Shah, Formulation Research Fellow, Cheshire, Merseyside & North Wales LRN, Medicines for Children Research Network, Royal Liverpool Children's NHS Trust, Liverpool, England; Dr R. Shaikh, Pakistan; Shasun Research Centre, Chennai, Tamil Nadu, India; Dr M.B. Shankar, Ministry of AYUSH, Government of India, New Delhi, India; Dr P.D. Sheth, Vice-President, International Pharmaceutical Federation, New Delhi, India; Ms S. Shifotoka, Namibia Medicines Regulatory Council, Windhoek, Namibia; Ms R. Shimonovitz, Head of Inspectorates, Institute for Standardization and Control of Pharmaceuticals, Ministry of Health, Israel; Shin Poong Pharmaceutical Co., Ltd, Seoul, Republic of Korea: Dr P.G. Shrotriya, Ambli, Ahmedabad, India; Dr M. Sigonda, Director-General, Tanzania Food and Drugs Authority, Dar-es-Salaam, United Republic of Tanzania; Dr G.L. Singal, Drugs Controller of Haryana, Department of Health Services, Civil Dispensary, Panchkula, Haryana, India; Dr A.K. Singh, Daman, India; Dr G.N. Singh, Secretary-cum-Scientific Director, Government of India, Central Indian Pharmacopoeia Laboratory, Ministry of Health and Family Welfare, Raj Nagar, Ghaziabad, India; Dr S. Singh, Professor and Head, Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Nagar, Punjab, India; Ms K. Sinivuo, Senior Researcher and Secretary, National Agency for Medicines, Helsinki, Finland; Dr L. Slamet, Jakarta Selatan, Indonesia; Dr M. Smid, Prague, Czech Republic; Mr D. Smith, Principal Scientist, SSI, Guateng, South Africa; Dr R. Smith, Wolfson Brain Imaging Centre, University of Cambridge, Cambridge, England; Dr N. Kumar Soam, Mankind Pharma Limited, Unit-II, Vill. Kishanpura, Paonta Sahib, Disst. Sirmour, India; Dr M. Da Luz Carvalho Soares, Brazilian Pharmacopeia Coordinator, Brazilian Health Surveillance Agency, Brasilia, Brazil; Society of Quality Assurance, Charlottesville, USA; Dr C. Sokhan, Deputy Director, Department of Drug and Food, Phnom Penh, Cambodia; Mrs U. Sonny-Afoekulu, GMP Inspectorate, National Agency for Food and Drug Administration and Control, Lagos, Nigeria; Dr V. Dias Sousa, Chairman, Pharmacopoeia Commission, Head, Brazilian Pharmacopoeia Coordination, Cofar General Office of Medicines and Biological Products, Brazilian Health Surveillance Agency, Brasilia, Brazil; Dr A. Spreitzhofer, AGES PharmMed, Vienna, Austria; Mr K. Srinivas, Group Legal Counsel, Trimulgherry, Secunderabad, Andhra Pradesh, India; Dr A. Bukirwa Ssenkindu, c/o National Drug Authority, Kampala , Uganda; State Regulatory Agency for Medical Activities, Ministry of Labour, Health and Social Affairs, Tbilisi, Georgia; Lone Steenholt, Senior Stability Scientist, Oral MDev QC, Novo Nordisk A/S, Måløv, Denmark; Dr J.A. Steichen, Manager, Regulatory and Quality Compliance Services, Safis Solutions, LLC, Indianapolis, IN, USA; Dr K. Stepniewska, Worldwide Antimalarial Resistance Network, Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, England; Dr Y. Stewart, Scientific, Technical and Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium; Dr L. Stoppa, Inspections & Certifications Department, Manufacturing Authorisation Office, Italian Medicines Agency, Rome, Italy; Dr R.W. Stringham, Scientific Director, Drug Access Team, Clinton Health Access Initiative, Boston, MA, USA; Dr N. Sullivan, Director, Sensapharm, Sunderland, England; Mr Philip Sumner, Pfizer Global Engineering, New York, NY, USA; Dr J. Sun, CFDA Inspectorate, Beijing, People's Republic of China; Professor X.-bo Sun, Director, WHO Collaborating Centre for Traditional Medicine, Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Beijing, China; Dr D. Sun Cuilian, Senior Analytical Scientist, Pharmaceutical Laboratory, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; Dr S. Sur, Kiev, Ukraine; Dr E. Swanepoel, Head, Operations, Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, South Africa; Dr J. Sy, Scientific Officer, Department of Chemistry, The University of Hong Kong, Hong Kong, Hong Kong SAR, China; Professor M. Sznitowska, Department of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland; Dr P. Tabernero, WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Oxford, England; Dr K. Takahashi, Senior Policy Advisor, Division of Regulations, Guidance and Standards, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Dr F. Takanashi, Ministry of Health, Labour and Welfare, Tokyo, Japan; Dr P. Taylor, GlaxoSmithKline, Brentford, Middlesex, England; Dr D. Teitz, Manager, Bristol-Myers Squibb Company, New Brunswick, NJ, USA; Dr Tepy Usia, Head, Sub-Directorate of Indonesian Indigenous Medicines Safety and Efficacy, National Agency of Drug and Food Control, Jakarta, Indonesia; Teva API Division, Petah Tiqva, Israel; Dr Than Maung, Rector, University of Traditional Medicine, Mandalay, Myanmar; Dr N. Thao, National Institute of Drug Quality Control, Hanoi, Viet Nam; Dr B.B. Thapa, Chief Drug Administrator, Department of Drug Administration, Ministry of Health and Population, Kathmandu, Nepal; Dr I. Thrussell, Geneva, Switzerland; Dr F.A. Tofiana, Directorate of Standardization of Traditional Medicine, Cosmetic and Complementary Product, National Agency of Drug and Food Control, Jakarta, Indonesia; Dr R. Torano, Pharmacopoeial Technical Expert, GlaxoSmithKline, Co. Durham, England; Dr P. Travis, Team Leader – Compendial Affairs Group, Pfizer Inc., Parsippany, NJ, USA; Ms M. Treebamroong, Senior Pharmacist, Drug Quality and Safety, Department of Medical Sciences, Bureau of Drug and Narcotic, Ministry of Public Health, Nonthaburi, Thailand; Mr R. Tribe, Holder, ACT, Australia; Associate Professor Trinh Van Lau, Director, National Institute of Drug Quality Control, Hanoi, Viet Nam; Professor Tsim W.K.K., Division of Life Science and Director, Centre for Chinese Medicine Research and Development, Hong Kong University of Science and Technology, Hong Kong, Hong Kong SAR, China; Dr L.K. Tsui, Director of the WHO Collaborating Centre for Traditional Medicine and Assistant Director (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kwun Tong, Kowloon, Hong Kong SAR, China; Dr C. Tuleu, Senior Lecturer and Deputy Director, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London, London, England; Dr H. Tumir, Head of Office for Quality Management, Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Dr Richard Turner, British Pharmacopoeia Commission, Medicines and Healthcare Products Regulatory Agency, London, England; Dr C. Nuhu Ugullum, Director of Laboratory Services, Tanzania Food and Drugs Authority, Dar es Salaam, United Republic of Tanzania; United States of America Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA; United States of America Food and Drug Administration, Office of Pediatric Therapeutics, Office of the Commissioner, Rockville, MD, USA; United States of America Pharmacopeial Convention, Rockville, MD, USA; Ms E. Uramis, Consultant, Havana, Cuba; Dr A.R.T. Utami, National Agency for Drugs and Food Control, Jakarta Pusat, Indonesia; Validation and Qualification Department, Pharmaceutical Laboratory, Esteve, Spain; Dr R. Vaillancourt, International Pharmaceutical Federation, The Hague, Netherlands; Mr M. van Bruggen, EU Liaison – Regulatory Intelligence, F. Hoffmann-La Roche, Basel, Switzerland; Mr F. Vandendriessche, Merck, Sharp and Dohme Europe, Brussels, Belgium; Dr J.E. van Oudtshoorn, Pretoria, South Africa; Dr D.A. van Riet-Nales, Member of the Quality Working Party, European Medicines Agency, Senior Assessor, Department of Chemical Pharmaceutical Assessments, College ter Beoordeling van Geneesmiddelen, Utrecht, Netherlands; Dr A.J. van Zyl, Sea Point, Cape Town, South Africa; Mr Salim Akbaralli Veljee, Director, Food and Drugs Administration, Directorate of Food and Drugs Administration, Government of Goa, Dhanwantari Bambolim, Goa, 403202, India; Dr A. Kumar Velumury, Cipla Ltd, New Delhi, India; Mr A. Vezali Montai, Specialist in Regulation and GMP, Agência Nacional de Vigilância, Brasília, Brazil; Dr C. Vicente, Johnson & Johnson, Fort Washington, PA, USA; Mrs L. Vignoli, Regulatory Affairs, Pharmaceuticals and Cosmetics, Roquette Cie, Lestren, France; Dr O. del Rosario Villalva Rojas, Executive Director, Quality Control Laboratories, National Quality Control Center, National Institute of Health, Lima, Peru; Mr L. Viornery, Agence nationale de sécurité du médicament et des produits de santé, Saint Denis, France; Dr L. Virgili, USA; Dr U. Walter, Intertek Life Sciences, Basle, Switzerland; Mr J. Wang, Deputy Commissioner, Dalian Food and Drug Administration, Dalian, Liaoning, People's Republic of China; Mr P. Wang, Deputy Secretary-General, Chinese Pharmacopoeia Commission, Beijing, People's Republic of China; Mrs T. Wang, Deputy Director, Shenzhen Municipal Institute for Drug Control, Shenzhen, People's Republic of China; Dr G. Wang'ang'a, Head, Microbiological and Medical Devices Units, National Quality Control Laboratory, Nairobi, Kenya; Dr A. Ward, Regulatory Affairs, Avecia Vaccines, Billingham, England; Ms J. Wasike, Director, Inspectorate, Surveillance & Enforcement, Pharmacy and Poisons Board, Nairobi, Kenya; Dr D. Waters, Acting Scientific Operations Advisor, Office of Laboratories and Scientific Services, Therapeutic Goods Administration, Woden, ACT, Australia; Dr W. Watson, Associate Manager, CMC Regulatory Affairs, Gilead Sciences International, Cambridge, England; Ms N. Wei, Associate Researcher, Division of Chemical Drugs, National Institutes for Food and Drug Control, Beijing, People's Republic of China; Mr J. Welink, Medicines Evaluation Board, Utrecht, Netherlands; Professor W. Wieniawski, Polish Pharmaceutical Society, Warsaw, Poland; Dr J. Welink, Medicines Evaluation Board, Utrecht, Netherlands; Dr Y. Wenzhi, Chinese Food and Drug Administration, Beijing, China; Mr J. Wilkinson, Director of Devices, Medicines and Healthcare products Regulatory Agency, London, England; Dr M. Jiwo Winanti, Senior GMP Inspector, National Authority for Food and Drug Control, Indonesia; Dr S. Wolfgang, US Food and Drug Administration, Silver Spring, MD, USA; Dr Wong Y.M.A., Senior Medical and Health Officer (Traditional Chinese Medicine), Chinese Medicine Division, Department of Health, Kowloon, Hong Kong SAR, China; World Self-Medication Industry, Ferney-Voltaire, France; Dr B. Wright, Group Manager, GMP/GDP, North East Region, Medicines Inspectorate, Medicines and Healthcare Products Regulatory Agency, York, England; Dr Y. Xu, Boehringer-Ingelheim, Pudong, Shanghai, China; Professor Z.-Y. Yang, Guangzhou Municipal Institute for Drug Control, Guangzhou, China; Professor Z.-Y. Yang, Member, United States Pharmacopeia International Health Expert Committee, Rockville, MD, USA; Ms C. Munyimba-Yeta, Director Operations (Plant), NRB Pharma Zambia Limited, Lusaka South Multi Facility Economic Zone, Lusaka, Zambia; Dr S. Yeung, London School of Hygiene and Tropical Medicine, England; Dr D. Yi, Scientist, US Pharmacopeia, Rockville, MD, USA; Mr T.H. Yung, Senior Pharmacist, Hospital Authority, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong SAR, China; Dr H. Yusufu, National Agency for Food and Drug Administration and Control, Abuja, Nigeria; Dr M. Zahn, Keltern, Germany; Mrs A.G. Zakiah, Senior Principal Assistant Director, Centre for Quality Control, National Pharmaceutical Regulatory Agency, Ministry of Health, Petaling Jaya, Selangor, Malaysia; Ms H. Zhang, Vice Director General and Chief Inspector, Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, China; Professor (Mrs) M. Zhang, Deputy Director, Institutes for Food and Drug Control, Jiangsu, and Vice Chairman, Antiobiotic Subcommittee, Chinese Pharmacopoeia Commission, China; Dr Q. Zhang, Senior Regulatory Specialist, Traditional Medicines Unit, Complementary Health Products Branch, Premarketing Divisions, Health Product Regulation Group, Health Sciences Authority, Helios, Singapore; Professor Zhao Z.Z., Associate Dean and Chair Professor of Teaching and Research Division, School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong SAR, China; Ms Zheng Bo, China Non Prescription Medicines Association, Beijing, China; Dr T. Zimmer, CD Safety, Quality & Environmental Protection, Boehringer Ingelheim, Ingelheim, Germany; Dr K. Zribi, Sfax, Tunisia; Dr N. Zvolinska, Deputy Director, Pharmaceutical Department, State Pharmacological Centre, Ministry of Health, Kiev, Ukraine.

© World Health Organization, 2019