The International Pharmacopoeia is based on the decisions of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. The Expert Committee acknowledges the following contributors at WHO: Dr A. Al-Nuseirat, WHO Regional Office for the Eastern Mediterranean; Dr S. Azatyan, Group Lead, Regulatory Convergence and Networks; Professor H.H. Balkhy, Assistant Director-General, Antimicrobial Resistance; Dr R. Ballocco, Unit Head, International Nonproprietary Names and Classification of Medical Products; Ms B. Cappello, Essential Medicines; Dr D. Catsoulacos, Inspection Services; Mr M. Chafai, Inspection Services; Ms H.L. Choi, Medicines Assessment; Mr M. Conrad, Inspection Services; Ms E. Cooke, Director, Regulation and Prequalification Department; Ms S. Croft, Inspection Services; Dr N. Dellepiane, Consultant, Regulatory System Strengthening; Dr J. Dong, Local Production and Assistance; Dr S. Estevão Cordeiro, Norms and Standards for Pharmaceuticals; Mr M. Freitas Dias, WHO Regional Office for the Americas; Dr V. Gigante, Norms and Standards for Pharmaceuticals; Dr J. Gouws, Team Lead, Inspection Services; Dr L. Gwaza, Facilitated Product Introduction; Ms S. Jones, Norms and Standards for Pharmaceuticals; Dr A. Khadem Broojerdi, Regulation and Safety; Dr I. Knezevic, Team Lead, Norms and Standards for Biological Products; Dr S. Kopp, Team Lead, Norms and Standards for Pharmaceuticals; Dr H. Langar, WHO Regional Office for the Eastern Mediterranean; Ms S. Laroche, Global Supply Policies; Dr S. Lewis, Consultant, Norms and Standards for Pharmaceuticals; Dr D. Lei, Norms and Standards for Biological Products; Mr D. Mubangizi, Unit Lead, Prequalification; Mr M. Musonda, Prequalification; Mr L. Nzumbu, Medicines Assessment; Dr C. Ondari, Acting Director, Health Product Policy and Standards; Dr R. Ostad Ali Dehaghi, Regulation and Safety; Mr M. Refaat, Regulation and Safety; Dr M. Roldao Santos, Regulatory System Strengthening; Mr V. Sachdeva, Inspection Services; Ms A. Sands, Incidents and Substandard/Falsified Medical Products; Dr H. Schmidt, Norms and Standards for Pharmaceuticals; Dr M. Shridhar, WHO Regional Office for South-East Asia; Mr H. Sillo, Team Lead, Regulation and Safety; Dr M. Simão, Assistant Director-General, Access to Medicines and Health Products; Dr M. Stahl, Team Lead, Medicines Assessment; Dr P. Steyn, Contraception and Fertility Care; Mrs I. Streipa, Inspection Services; Mrs M. Valentin,Regulatory Convergence and Networks; Ms C. Vogel, Norms and Standards for Pharmaceuticals; Mr W.Z. Worku, Medicines Assessment; and Mrs H. Yin, Medicines Assessment.

Technical guidance was prepared with the financial assistance of the Bill & Melinda Gates Foundation, the German Federal Ministry of Health, the Global Fund to Fight AIDS, Tuberculosis and Malaria and the United Nations Development Programme.

The Expert Committee also acknowledges with thanks the valuable contributions made to its work by the following agencies, institutions, organizations, pharmacopoeias, WHO collaborating centres, WHO programmes (especially the Regulatory and Prequalification Teams) and individuals:

Brazilian Health Surveillance Agency, Brasília DF, Brazil; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring (MD), USA; Comisión Federal para la Protección contra Riesgos Sanitaríos, and Administration and Finance, Secretaria de Salud, Mexico City, Mexico; European Commission, Brussels, Belgium; European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France; European Healthcare Distribution Association, Brussels, Belgium; European Medicines Agency, Amsterdam, Netherlands; Global Self-Care Federation (formerly World Self Medication Industry), Nyon, 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 Federation ASBL, Brussels, Belgium; International Pharmaceutical Federation, The Hague, Netherlands; International Society for Pharmaceutical Engineering, Tampa (FL), USA; Medicines for Europe, Brussels, Belgium; Medicines and Healthcare Products Regulatory Agency, Inspection, Enforcement and Standards Division, London, United Kingdom; National Agency of Drug and Food Control, Jakarta Pusat, Indonesia; National Food and Drug Authority, Kampala, Uganda; Parenteral Drug Association, Bethesda (MD), USA; Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland; The Global Fund to Fight AIDS, Tuberculosis and Malaria, Geneva, Switzerland; The Stop TB Partnership, Geneva, Switzerland; Therapeutic Goods Administration, Woden, ACT, Australia; Turkish Medicines and Medical Devices Agency, Ankara, Turkey; United Nations Children’s Fund, Supply Division, Copenhagen, Denmark; United Nations Development Programme, Châtelaine, Switzerland; United Nations Industrial Development Organization, Geneva, Switzerland; United Nations Population Fund, Copenhagen, Denmark.

Laboratoire National de Contrôle des Produits Pharmaceutiques, Dély Ibrahim, Algeria; Instituto Nacional de Medicamentos, Buenos Aires, Argentina; Expert Analytic Laboratory, Centre of Drug and Medical Technology Expertise, Yerevan, Armenia; University of Liège, Liège, Belgium; 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; Changzhou Center for Food and Drug Control, Changzhou, China; Chengdu Institute for Food and Drug Control, Sichuan, China; Chongqing Institute for Food and Drug Control, Chongqing City, China; Dalian Drug Quality Control Institute, Dalian City, China; Guangzhou Municipal Institute for Drug Control, Guangzhou, China; Hubei Institute For Drug Control, Wuhan, China; Jiangsu Institute for Food and Drug Control, Nanjing, China; Guangdong Institute for Drug Control, Guangdong, China; National Institutes for Food and Drug Control, Beijing, China; Shandong Institute for Food and Drug Control, Shandong, China; Shenzhen Institute for Drug Control Jiangsu Province, Shenzhen, China; Sichuan Institute for Food and Drug Control, Sichuan, China; Suzhou Institute for Drug Control, Jiangsu, China; Tianjin Institute for Drug Control, Tianjin, China; Wuxi Institute For Drug Control, Jiangsu, China; Xiamen Institute for Food and Drug Control, Xiamen, China; Zhejiang Institute for Drug and Food Control, Zhejiang, China; Medicamentos y Productos Biológicos, Instituto Nacional de Vigilancia de Medicamentos y Alimentos, 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; Agency for Medicinal Products and Medical Devices of Croatia, Official Medicines Control Laboratory Division, Zagreb, Croatia; Oficina Sanitaria Panamericana, WHO on behalf of Centro para el Control Estatal de Medicamentos, Havana, Cuba; National Organization for Drug Control and Research, Cairo, Egypt; Food, Medicine and Healthcare Administration and Control Authority of Ethiopia, Addis Ababa, Ethiopia; Jimma University Laboratory of Drug Quality, Jimma, Ethiopia; Centrale Humanitaire des Métiers de la Pharmacie, Clermont Ferrand, France; Center for Pharmaceutical Advancement and Training, Accra, Ghana; 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; National Quality Control Laboratory of Drug and Food, National Agency for Food and Drug Control, Yogyakarta, Indonesia; Food and Drugs Control Laboratories, Ministry of Health and Medical Education, Tehran, Islamic Republic of Iran; Caribbean Public Health Agency Drug Testing Laboratory, Kingston, Jamaica; Mission for Essential Drugs and Supplies, Nairobi, Kenya; National Quality Control Laboratory for Drugs and Medical Devices, Nairobi, Kenya; Central Analytical Laboratory, Bishkek City, Kyrgyzstan; Arwan Pharmaceutical Industries Lebanon s.a.l., Jadra, Lebanon; Food and Drug Quality Control Centre, Ministry of Health, Vientiane, Lao People’s Democratic Republic; Ministry of Health, Maseru, Lesotho; 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 de Qualité des Médicaments, Nouakchott, Mauritania; Laboratoire National de Contrôle des Médicaments, Rabat, Morocco; National Laboratory for Medicine Quality Testing Ministry of Health, Maputo, Mozambique; Quality Surveillance Laboratory, Windhoek, Namibia; National Medicines Laboratory, Department of Drug Administration, Kathmandu, Nepal; Laboratoire National de Santé Publique et d’Expertise, Niamey, Niger; National Agency for Food and Drug Administration and Control, Abuja, Nigeria; 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; Getz Pharma (Pvt.) Ltd, Karachi, 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; Saudi Food and Drug Authority, Section Head of Operations Performance Measurement, Riyadh, Saudi Arabia; Laboratoire National de Contrôle des Médicaments, Dakar Etoile, Senegal; Drug Quality Control Laboratory, Ministry of Health, Victoria, Seychelles; National Pharmaceutical Quality Control Laboratory, Registrar Pharmacy Board of Sierra Leone, Freetown, Sierra Leone; WHO Collaborating Centre for Drug Quality Assurance, Pharmaceutical Division, Applied Sciences Group, Singapore; Adcock Ingram Healthcare, Bryanston, 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, Tanzania Food and Drug Authority, Dar es Salaam, United Republic of Tanzania; School of Pharmacy, Muhimbili University of Health and Allied Sciences, 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, Ministry of Health, Kiev, Ukraine; Laboratory of Pharmaceutical Analysis, State Pharmacological Centre, Ministry of Health, Kiev, Ukraine; Laboratorio Control de Productos Ministerio de Salud Pública, 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; Zambia Medicines Regulatory Authority, Lusaka, Zambia; Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.

African Pharmacopoeia, Abuja, Nigeria; Farmacopea Argentina, Buenos Aires, Argentina; Austrian Pharmacopoeia, Vienna, Austria; State Pharmacopoeia of the Republic of Belarus, Minsk, Belarus; Belgian Pharmacopoeia Commission, Brussels, Belgium; Agency for Medicinal Products and Medical Devices, Sarajevo, Bosnia and Herzegovina; Farmacopeia Brasileíra, Brasilía DF, Brazil; Bulgarian Drug Agency, Sofia, Bulgaria; Farmacopea Chilena, Valparaíso, Chile; Chinese Pharmacopoeia Commission, Beijing, China; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Pharmaceutical Services, Nicosia, Cyprus; Czech Pharmacopoeia Commission, Prague, Czechia; Danish Pharmacopoeia Commission, Copenhagen, Denmark; Permanent Commission of the Egyptian Pharmacopoeia, Cairo, Egypt; State Agency of Medicines, Tartu, Estonia; Pharmacopoeial Committee of the Eurasian Economic Union, Moscow, Russian Federation; European Pharmacopoeia, European Directorate for the Quality of Medicines and HealthCare, Council of Europe, Strasbourg, France; Finnish Medicines Agency Pharmacopoeia Committee, 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; Greek Pharmacopoeia Commission, Holargos Attikis, Greece; Hungarian Pharmacopoeia Commission, Budapest, Hungary; Icelandic Medicines Agency, Reykjavik, Iceland; Indian Pharmacopoeia Commission, Ghaziabad, India; Indonesian Pharmacopoeia Commission, Jakarta Pusat, Indonesia; The International Pharmacopoeia, World Health Organization, Geneva, Switzerland; Iranian Pharmacopoeia, Tehran, Islamic Republic of Iran; Italian Pharmacopoeia Commission, Rome, Italy; Committee of the Japanese Pharmacopoeia, Pharmaceutical Affairs Food Sanitation Council, Tokyo, Japan; The State Pharmacopoeia of the Republic of Kazakhstan, Almaty, Kazakhstan; Lithuanian Pharmacopoeia Commission, Vilnius, Lithuania; Malta Medicines Authority, San Gwann, Malta; Mexican Pharmacopoeia, México DF, Mexico; Norwegian Pharmacopoeia Authority, Oslo, Norway; Pakistan Pharmacopoeia Commission, Islamabad, Pakistan; Philippines Pharmacopoeia, Manila, Philippines; Polish Pharmacopoeia Commission, Warsaw, Poland; Portuguese Pharmacopoeia, Porto, Portugal; Pharmacopoeia of the Republic of Korea, Chuncheongbuk-do, Republic of Korea; Romanian Pharmacopoeia Commission, Bucharest, Romania; State Pharmacopoeia Council of the Ministry of Health of the Russian Federation, Moscow, Russian Federation; Serbian Pharmacopoeia, Belgrade, Serbia; Slovak Pharmacopoeia Commission, Bratislava, Slovakia; Slovenian Pharmacopoeia Commission, Ljubljana, Slovenia; Spanish Pharmacopoeia, Madrid, Spain; Swedish Pharmacopoeia Commission, Uppsala, Sweden; Swiss Pharmacopoeia, Bern, Switzerland; Thai Pharmacopoeia Commission, Nonthaburi, Thailand; Turkish Medicines and Medical Devices Agency, Department of Analysis and Control Laboratories, Vice Presidency of Economic Assessments and Laboratory Services, Ankara, Turkey; Pharmacopoeia of Ukraine, Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, Kharkov, Ukraine; British Pharmacopoeia Commission, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; United States Pharmacopeia, Rockville (MD), USA; Vietnamese Pharmacopoeia Commission, Hanoi, Viet Nam.

WHO Centre Collaborateur pour la Conformité des Médicaments, Laboratoire National de Contrôle des Produits Pharmaceutiques, Algiers, Algeria; WHO Collaborating Centre for Drug Quality Assurance, Therapeutic Goods Administration Laboratories, Woden, ACT, Australia; WHO Collaborating Centre for Drug Quality Assurance, National Institutes for Food and Drug Control, Beijing, China; 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.

Antimicrobial Resistance Division, WHO, Geneva, Switzerland; Regulation and Prequalification, WHO, Geneva, Switzerland; Global Malaria Programme, Universal Health Coverage/Communicable and Noncommunicable Diseases, WHO, Geneva, Switzerland; Global Tuberculosis Programme, WHO, Geneva, Switzerland; HIV/AIDS, WHO, Geneva, Switzerland; International Nonproprietary Names and Classification of Medical Products, WHO, Geneva, Switzerland; Office of the Legal Counsel, WHO, Geneva, Switzerland; Prequalification, WHO, Geneva, Switzerland; Prevention and Control of Noncommunicable Diseases, WHO, Geneva, Switzerland; Regulation of Medicines and other Health Technologies, WHO, Geneva, Switzerland; Technologies Standards and Norms, WHO, Geneva, Switzerland.

WHO Regional Office for Africa, Brazzaville, Congo; WHO Regional Office for the Americas, 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.

Dr H. Abboud, National Drug Quality Assurance and Research Laboratories, Damascus, Syrian Arab Republic; ACS Dobfar S.p.A., Italy; Dr S. Adam, Senior Manager for Regulatory and Scientific Affairs, International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland; Professor E. Adams, Pharmaceutical Analysis, K.U. Leuven, Leuven, Belgium; Dr A. Adisa, Principal Evaluator, Therapeutic Goods Administration, Woden, Australia; Dr F. Aguilar-Parrilla, Bayer AG, Berlin, Germany; Mr Y. Al-Nujaym, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Professor V.R. Alamà, Universidad Cardenal, Valencia, Spain; Dr I. Aljuffali, Executive Vice-President, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Dr J. Albanese, Director, Analytical Strategy and Compliance, Janssen Research and Development, USA; Mr I. Alstrup, Medicines Inspector, Danish Medicines Agency, Copenhagen, Denmark; Dr M. Ali Alqubati, Pharmacist, Sana’a, Yemen; Mr D. Anderson, Global Business Unit Quality Director, Solvay, Brussels, Belgium; Dr T. Ando, Division of Pharmacopoeia and Standards for Drugs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Mr K. Andrei, Federal State Budgetary Institution, Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Moscow, Russian Federation; Dr M.H. Al Rubaie, Director General, Ministry of Health, Muscat, Oman; Ms Y. Anastasio, National Administration of Drugs, Food and Medical Devices, Buenos Aires, Argentina; Dr B. Appiasam-Dadson, Food and Drugs Authority, Accra, Ghana; Mr R. Arcuri, Executive President, FarmaBrasil Group, Brasilia, Brazil; Dr A. Arias, Senior Advisor, Health Canada, Ottawa, Canada; Ms S. Arsac-Janvier, International Committee of the Red Cross, Geneva, Switzerland; Dr M. Assalone, Technical Secretary of Argentinian Pharmacopoeia, Medicines National Institute, Buenos Aires, Argentina; Aurobindo Pharma Limited, Hyderabad, India; Ms S. Ayral, World Trade Organization, Geneva, Switzerland; Dr O. Badary, National Organization for Drug Control and Research, Cairo, Egypt; Ms H. Baião, Infarmed, Lisbon, Portugal; Mr N. Banerjee, Microbiology Head, Aurobindo Pharma, East Windsor (NJ), USA; Mr A. Bansal, Drugs Inspector, Central Drugs Standard Control Organisation, New Delhi, India; Mr A. Barojas, Technical Adviser, Product Quality and Compliance, Durham (NC), USA; Mr I. Basade, Mylan Laboratories Ltd, Hyderabad, India; Professor S.A.O. Bawazir, Saudi Food and Drug Authority, Riyadh, Saudi Arabia; Professor M. Beksinska, Deputy Executive Director, MatCH Research Unit, Durban, South Africa; Dr M. Belayneh, Pharmacist, United States Agency for International Development, Washington DC, USA; Professor M. Bermejo-Sanz, Department of Pharmaceutical Technology and Pharmaceutics, Universidad Miguel Hernández de Elche, Alicante, Spain; Mr L. Blankenfeldt, trans-o-flex Express GmbH, Weinheim, Germany; Dr A. Blommaert, Faculty of Pharmacy, Paris, France; Ms R.F. Boadu, Food and Drugs Authority, Accra, Ghana; Mr S. Bodemeier, Ritex GmbH, Bielefeld, Germany; Mr B. Boedecker, Hanover, Germany; Mr M. Boisen, Quality Intelligence Manager, Novo Nordisk A/S, Bagsværd, Denmark; Mr K. Bokaba, Medicines Control Council, South Africa; Ms A. Bonneure, Active Pharmaceutical Ingredients Committee, European Chemical Industry Council, Brussels, Belgium; Mr V. Bonrilla, Comisión para el Control de Calidad de Medicamentos, Montevideo, Uruguay; Professor R. Boudet-Dalbin, Paris, France; Mr R.M. Bretas, Good Manufacturing Practice Inspector, Health Regulatory Agency, Brasília, Brazil; Dr M. Brits, Operations Manager, Research Institute for Industrial Pharmacy Inc., Centre for Quality Assurance of Drugs, North-West University, Potchefstroom, South Africa; Dr R. Bose, Deputy Drugs Controller, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, New Delhi, India; Ms Y. Bowman, Netherlands; Mr D. Brunner, Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; Dr T. Brusselmans, Directorate General Inspection, Industry Division, Medicines, Federal Agency for Medicines and Health Products, Brussels, Belgium; Ms K. Bugge Skou, Scientific Officer, Lægemiddelstyrelsen, Danish Medicines Agency, Denmark; Dr N. Bunnuan, Director, Manufacturing Quality Assurance, LifeStyles, Bangkok, Thailand; Mr M. Bursian, Head Archive Operations, Grünenthal GmbH, Aachen, Germany; Mr Y. Cai, Process Support Specialist, Fresenius Kabi SSPC, Wuxi, China; Dr M. Camelia, Radiologist, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Ms S. Camplisson, Director of Pharmaceutical Technology, Allergan Pharmaceuticals Ireland, Westport, Ireland; Dr A.M. Cancel, Product Quality and Compliance, FHI 360, Durham, NA, USA; Mr Y. Cao, Deputy Director of the 4th Divison Inspections, Centre for Food and Drug Inspection of National Medical Products Administration, Beijing, China; Dr N. Cappuccino, Chair, Science Committee, International Generic and Biosimilar Medicines Association, Geneva, Switzerland; Mr G. Carroll, General Manager Development Programme, Operations Manager and Senior Inspector, Inspections Enforcement and Standardization, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Ms M. Casais, Senior Advisor, Bill & Melinda Gates Foundation, London, United Kingdom; Dr J.M. Caudron, United Nations Development Programme, Châtelaine, Switzerland; Mr S. Cavalheiro Filho, Assistant Manager, Regulatory Affairs, International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland; Mr S. Champaneri, Certification Manager/Product Technical Specialist, British Standards Institution, London, United Kingdom; Dr T. Chanprapaph, Thailand Food and Drug Administration, Nonthaburi, Thailand; Ms P. Chauhan, Global Regulatory eCommerce & Intelligence, Reckitt Benckiser Healthcare, Hull, United Kingdom; Ms J. Chen, World Customs Organization, Brussels, Belgium; Mr M.R. Chowdhury, Novartis (Bangladesh) Ltd, Site Data Integrity Lead, Dhaka, Bangladesh; Dr Lakshman Chunduru, Laurus Labs, India; Dr W.K. Chui, Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore; Ms A. Clark, Senior External Engagement Manager, United States Pharmacopeia, Rockville (MD), USA; Ms A. Cockrell, Executive Director, Society of Quality Assurance, Charlottesville (VA), USA; Dr R. Conocchia, European Medicines Agency, Amsterdam, Netherlands; Ms A.G. Cord’homme, Product Safety Manager, Health, Environmental and Regulatory Services, Puteaux, France; Dr A.R. Cornelio Geyer, Agência Nacional de Vigilância Sanitária (Anvisa), Brasilía, Brazil; Dr H. Corns, Principal Pharmacopoeial Scientist, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Dr R. Cumberbatch, Director, International and Regulatory Affairs, Animal Health Institute, Washington DC, USA; Ms V. Dagois, Director, CAPE-Expert, Cannet, France; Mr H. Dahmani, Pharmacist Quality Assessor, National Control Laboratory of Tunisia, Tunis, Tunisia; Mr D.I. Dalal, Executive Quality Assurance, Zim Laboratories Ltd, Nagpur, India; Mrs H.H. Dam, Officer, Drug Business Administration Division, Drug Administration of Viet Nam, Hanoi, Viet Nam; Ms Daryani, Indonesian Pharmacopoeia Commission, National Agency of Drug and Food Control, Jakarta Pusat, Indonesia; Mr D.X. Da Silva, Technical Regulatory and Innovation Analyst, Sindusfarma, São Paulo, Brazil; Ms C. Daugherty, Specialist, Quality Regulatory Intelligence, GlaxoSmithKline plc, Montrose, United Kingdom; Dr M.C. De Angelis, Technical Secretary, Argentinian Pharmacopoeia, Buenos Aires, Argentina; Professor T. Dekker, Research Institute for Industrial Pharmacy, North-West University, Potchefstroom, South Africa; Dr V. Dias Sousa, Directorate Advisor, Brazilian Health Surveillance Agency, Brasilía, Brazil; Dr M. Dmitriieva, Scientifc Secretary, Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, State Service of Ukraine on Medicinal Products, Ministry of Health, Kharkov, Ukraine; Professor E. Doelker, Geneva, Switzerland; Dr D. Dimas, Good Manufacturing Practice Inspector, National Organization for Medicines, Attiki, Greece; Mr J. Dobaria, Hetero Labs Ltd, Hyderabad, India; Dr P. Doerr, Bern, Switzerland; Dr O. Douglas; Mrs S. Dube-Mwedzi, South Africa Development Community, Medicines Regulatory Harmonization Project Coordinator, Zazibona Inspectorate, Medicines Control Authority of Zimbabwe, Harare, Zimbabwe; Mr W. Drummond, Senior Director, Charles River, Laboratories, Horsham (PA), USA; Professor G. Dutta, Quality Manager, A.N. Pharmacia Laboratories Pvt Ltd., West Bangal, India; Egis Pharmaceuticals Plc., Budapest, Hungary; Mr A. Evans, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Executive Direction of International Operation, Comision Federal para la Proteccion contra Riesgos Sanitarios, Mexico City, Mexico; Mr M. Falcon, Regulations and Standards Surveillance Manager, LFB S.A., Courtaboeuf Cedex, France; Dr A.M. Fallas, Technical Director, Gutis Ltda, San José, Costa Rica; Professor R. Fernandopulle, General Sir John Kotelawala Defence University, Ratmalana, Sri Lanka; Ms G.F. Ferreiro, Centro para el Control Estatal de Medicamento, Equipos y Dispositivos Médicos, Havana, Cuba; Ms M.P. Filliot, Global Quality Management APIs & Strategic Raw Materials, Bayer Consumer Care A.G., Basel, Switzerland; Dr G. Fischer, Head of Quality Regulatory Intelligence, Boehringer Ingelheim Corporate Center GmbH, Rhein, Germany; Mr M. Fleischer, Director, Quality, Transport, World Courier, Berlin, Germany; Dr A. Flueckiger, former Head of Occupational Health and Toxicology, Roche, PattenIn, Germany; Dr R. Forsyth, Senior Consultant, Forsyth Pharmaceutical Consulting, Royersford (PA), USA; Professor I. Fradi Dridi, Service Pharmacie, Centre National de Greffe de Moelle Osseuse, Faculté de Pharmacie de Monastir, Monastir, Tunisia; Mr G.M. Francis, Pharmacy and Poisons Board, Nairobi, Kenya; Mr M. Friis, Epista Life Science, Hørsholm, Denmark; Ms K. Froidbise, Head of Division Industry, Directorate General Inspection, Federal Agency for Medicines and Health Products, Brussels, Belgium; Ms R. Gadde, Vice President, Global Health, Becton Dickinson, Franklin Lakes (NJ), USA; Mr J. Gaeseb, Namibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia; Mr A. Garcia-Aríeta, Head of Service on Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency of Medicines and Medical Devices, Madrid, Spain; Mr O. Garg, Chairman and Managing Director, Cupid Ltd, Nashik, India; Mr J. Gaeseb, Windhoek, Namibia; Dr K. Gao, National Institutes for Food and Drug Control, Beijing, China; Professor A. Genazzani, Novara, Italy; Dr M. Gencoglu, Regulatory Affairs Manager, International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland; Mr J. Gerofi, Managing Director, Enersol, Sydney, Australia; Ms A.L. Ghilini, Quality Control Director, Minakem SAS, Dunkerque, France; Dr G. Gildeeva, Federal State Budgetary Institution, Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health, Moscow, Russian Federation; Mrs E. Gladkaya, Head, Quality Assurance Division, Federal State Budgetary Institution, Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health, Moscow, Russian Federation; Ms B. Goede, Senior International Product Manager, Virology, Roche, San Francisco (CA), USA; Mr C. B. Goldsmith Químico Farmacéutico, Santiago, Chile; Dr J. Gordon, Wolfville, Nova Scotia, Canada; Mr D. Greney, Quality Assurance Director, Recipharm, Kaysersberg, France; Mr P. Goyal, Senior Manager Quality, Lupin Ltd, Mumbai, India; Ms O. Gubareva, Head, International Cooperation Department, Federal State Budgetary Institution, Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health, Moscow, Russian Federation; Ms I. Guerra, Associate Manager, Regeneron UK, Tarrytown (NY), USA; Ms N.M. Guerrero Rivas, Radiofarmacia de Centroamérica, S.A., Panamá, Panama; Ms M. Guest, Associate Principal Scientist, AstraZeneca Pharmaceuticals, Macclesfield, United Kingdom; Ms R.C. Guimarães, Quality Deputy Director, Bio-Manguinhos-Fiocruz, Rio de Janeiro, Brazil; Mr C.S. Gumpally, Senior Executive, Neopharma LLC, Abu Dhabi, United Arab Emirates; Professor Z.P. Guo, Chinese Pharmacopoeia Commission, Beijing, China; Guilin Pharmaceutical Company Ltd, Guilin, China; Ms P. Hauschildt de Oliveira Mendes, Regulatory Expert, Health Regulatory Agency, Brasília, Brazil; Mr O. Hawari, Quality Assurance Manager, External Collaborations, Hoffman La Roche, Mississauga, ON, Canada; Ms Sri Hayanti, National Agency of Drug and Food Control, Jakarta, Indonesia; Mr W. Heimes, Administration Manager, European Compliance Academy Foundation, Heidelberg, Germany; Dr R. Hernández Medina, Mexican Pharmacopoeia, Mexico City, Mexico; Dr M. Heuermann, Official Medicines Control Laboratory, Münster, Germany; Mr D. Hill, David Hill & Associates, International Latex Consultancy, Elsenham, United Kingdom; Ms M. Hirschhorn, Head, Quality and Chemistry Sector, Comisión para el Control de Calidad de Medicamentos, Montevideo, Uruguay; Mr J. Hodgson, Pharmaceutical Inspection Co-operation Scheme Secretariat, Geneva, Switzerland; Mr P. van der Hoeven, European Chemical Industry Council, Managing Director, Association for Professionals in Infection Control and Epidemiology, Brussels, Belgium; Dr P. Holland, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Mr M. Holmes, Management Committee Member, Pharmaceutical and Healthcare Sciences Society, Swindon, United Kingdom; Ms B. Holst, Danish Medicines Agency, Copenhagen, Denmark; Mr G. Holzem, Senior Manager, Grünenthal GmbH, Aachen, Germany; Dr X. Hong, Pharmacopoeia of the People’s Republic of China, Beijing, China; Professor J. Hoogmartens, Catholic University of Leuven, Leuven, Belgium; Ms S. Hoogmoed, Regulatory Affairs and Assurance Manager, ACIC Pharmaceuticals Inc., Coral Springs (FL), USA; Mr I. Hussain, Information Technology Good Practice Validation Manager, Zealand Pharma IT, Soeborg, Denmark; Dr N. Hussain, Associate Director, Gilead Sciences, London, United Kingdom; Ms T.J. Hutadjulu, National Agency of Drug and Food Control, Jakarta, Indonesia; Dr K.E. Iddir, Director, Direction de la pharmacie et du médicament de Tunisie, Tunis, Tunisia; Indian Pharmaceutical Congress, Chennai, India; Mr S. Indoe, Associate Director, Merck Manufacturing Division, Pharmaceutical technical Operations Logistics and Distribution Technology, Merck & Co., Kenilworth (NJ), USA; Indus Medicare, Hyderabad, India; Ipca Laboratories Ltd., Maharashtra, India; Dr G.P.S. Jadaun, Senior Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad, India; Mr J. Jadav, Senior Executive, Assurance, Concord Biotech Ltd., Ahmedabad, India; Dr S.A. Jaffar, Director General, Pharmaceutical Affairs and Drug Control, Ministry of Health, Muscat, Oman; Dr P. Jakšić, Principal Advisor for Pharmacopoeia, Official Medicines Control Laboratory Division, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Professor S. Jin, Chief Expert for Pharmaceutical Products, National Institutes for Food and Drug Control, Beijing, China; Mr D. John, Senior Technical Manager, Animal Health Europe, Brussels, Belgium; Mr J.L. Jouve, A3P association, eCompliance SIG Chairman, Lyon, France; Dr U. Juárez-Sevilla, Mexican Pharmacopoeia, Mexico City, Mexico; Ms A. Julsing, Medicines Control Council, Pretoria, South Africa; Professor E.A. Kaale, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, United Republic of Tanzania; Mr B. Kalaivani, Manager Assurance and Risk Assessment, TTK Healthcare Ltd, Protective Devices Division, Chennai, India; Ms J. Kalina, Corporate Affairs Manager, European Healthcare Distribution Association, Brussels, Belgium; Dr S. Kamakshinatha, Pharmedices Technical Services, Chennai, India; Mr S. Kare Nielsen, Chairman, Novo Nordisk Focus Group on Supply Chain, Novo Nordisk A/S, Bagsværd, Denmark; Karex, Selangor, Malaysia; Mr A. Kayongo, Consultant, UBOPACT Africa Ltd, Mukono, Uganda; Dr S. Keitel, Director, European Directorate for the Quality of Medicines and Health Care, Council of Europe, Strasbourg, France; Mr A. Kessete, Acting Head, Product Evaluation and Registration, National Medicines and Food Administration, Ministry of Health, Asmara, Eritrea; Mr D. Kharote, Assistant General Manager, Serum Institute of India Pvt. Ltd, Pune, India; Dr S. Khoja, Deputy General Manager, Quality Assurance, Skant Healthcare Ltd, Vapi, India; Mr S. Kigera, Mission for Essential Drugs and Supplies, Nairobi, Kenya; Mrs K. Kikule, Arlington (VA), USA; Dr N.H. Kim, Pharmaceutical Standardization Research and Drug Research Division, National Institute of Food and Drug Safety Evaluation, Chungcheongbuk-do, Republic of Korea; Mr S. Kisoma, Tanzania Medicines and Medical Devices Authority, Dar-es-Salaam, United Republic of Tanzania; Dr N.N.K. Kkrumah, Medicines Evaluation and Registration Department, Food and Drug Administration, Cantonment-Accra, Ghana; Mr S. Klidzia, Assurance Lead, Fujifilm Diosynth Biotechnologies, Bryan (TX), USA; Dr E Klenke, Head Preclinical Review, Bern, Switzerland; Mrs W. Kongsuk, Bureau of Drug and Narcotic, Department of Medical Sciences, Nonthaburi, Thailand; Dr A. Korde, Technical Officer, Radioisotope Products and Radiation Technology Section, Division of Physical and Chemical Sciences, International Atomic Energy Agency, Vienna, Austria; Dr E. Kovaleva, Deputy Director of the Centre for Evaluation and Control of Medicinal Products, Moscow, Russian Federation; Dr A. Krauss, Woden, Australia; Mr P. Kumar, Senior Manager, Institutions, International Business Division, HLL Lifecare Ltd, Trivandrum, India; Dr A. Kupferman, Industy Pharmacist, Bangkok, Thailand; Dr Z. Kusynova, Lead for Policy, Practice and Compliance, International Pharmaceutical Federation, The Hague, Netherlands; Dr W. Kwiringira, National Drug Quality Control Laboratory, National Drug Authority, Kampala, Uganda; Ms I. Laccisaglia, Global Quality Specialist, Kuehne+Nagel, Contern, Luxemburg; Professor J. Ladutko Mikhailovna, Department of Technology of Dosage Forms, Federal State Budgetary Educational Institution of Higher Education, St Petersburg State Chemical Pharmaceutical University, Ministry of Health, Moscow, Russian Federation; Mr K. Laenen, Quality and Regulatory Affairs Manager, Medicines for Europe, Brussels, Belgium; Laurus Labs Limited, Visakhapatnam, Italy; Ms L. Lavergne. Technical Coordinator, Pharmacist, Quality Medicine for All, Paris, France; Professor B.J. Lee, College of Pharmacy, Ajou University, Suwon, Republic of Korea; Ms Y. Lee, Ministry of Food and Drug Safety, Seoul, Republic of Korea; Professor M.P. Lefranc, International ImMuno Information Genetics System, Laboratoire d’Immunogénétique Moléculaire, Toulouse, France; Dr K.C. Leong, Health Science Authority, Singapore; Ms F. Lessa, Programme Specialist, Health Systems and Services, Medicines and Health Technologies Unit, Pan American Health Organization, Washington DC, USA; Dr B. Li, Director General, National Institutes for Food and Drug Control, Ministry of Public Health, Beijing, China; Dr J. Lidner, Parallel Distribution and Certificates, Committees and Inspections Department, European Medicines Agency, Amsterdam, Netherlands; Dr M. Limoli, Senior International Health Advisor, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring (MD), USA; Dr R. Lino de Brito and Agência Nacional de Vigilancia Sanitaría, Brasilía, Brazil; Mr L. Locks, World Trade Organization, Geneva, Switzerland; Dr A. Lodi, Head of Laboratory, European Directorate for the Quality of Medicines and Health Care, Council of Europe, Strasbourg, France; Dr S. Logez, Procurement and Supply Management Specialist, United Nations Development Programme, Geneva, Switzerland; Ms S. Lohani, General Manager, Beximco Pharmaceuticals Ltd, Gazipur, Bangladesh; Ms H. Longden, Senior Marketing Manager, Informatics and Regulatory Compliance, Waters Corporation, Milford (MA), USA; Dr A.L. Lopes da Silva, Health Regulation Specialist, Brazilian Pharmacopoeia Coordination, Brazilian Health Regulatory Agency, Brasilía, Brazil; Ms A. López de la Rica Manjavacas, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain; Ms M.Y. Low, Director, Pharmaceutical Division, Applied Sciences Group, Health Sciences Authority, Singapore; Ms B. Lugosi-Czangár, Validation Manager, Gedeon Richter Plc, Budapest, Hungary; Lupin Ltd, Mumbai, India; Dr C. Macé, Senior Health Procurement and Supply Chain Advisor, Global Fund/Health Implementation Support Team, United Nations Development Programme, Geneva, Switzerland; Mr D. Madan, Quality Control Specialist, Mylan Dublin Respiratory, Dublin, Ireland; Mr T. Madigan, Good Distribution Practice Inspector, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Mr P. Magyari, Plant Manager, Gedeon Richter Plc, Budapest, Hungary; Ms G.N. Mahlangu, Director, Technical Services, Medicines Control Authority, Harare, Zimbabwe; Professor S.F. Malan, Director of School of Pharmacy, University of the Western Cape, Bellville, South Africa; Dr J.D. Mallet, Paris, France; Dr K.P. Mang, Head of Segment Management Process Analytics, Mettler-Toledo GmbH, Giessen, Germany; Mangalam Drugs and Organics Limited, Mumbai, India; Ms L. Margaryants, Scientific Centre of Drug and Medical Technology Expertise, Yerevan, Armenia; Mrs D. Marin, Director, Drug Inspectorate Unit, Ministry of Health, Belize; Dr C. Masinga, Lab Supervisor, Virbac Veterinary, Johannesburg, South Africa; Dr J.Y. Martey, Accra, Ghana; Mr W. Mathiya, Pharmacy Medicines and Poisons Board of Malawi, Lilongwe, Malawi; Mrs R. Matos Gonçalves, Brazilian Health Regulatory Agency, Brasília, Brazil; Dr J.L. Mazert, Paris, France; Dr A. Matias, Quality Control First Line Leader, GlaxoSmithKline Plc, Grand Rapids (MI), USA; Mr D. McCartney, Head of SRHR Connect, International Planned Parenthood Federation, London, United Kingdom; Dr R.D. McDowall, Director, RD McDowall Ltd, Bromley, United Kingdom; Professor M. McIntosh, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Australia; Dr F. Meadows, Senior Technical Advisor, US Pharmacopeial Convention, Rockville (MD), USA; Mr M. Meakin, Vice-President, Global Quality Regulatory and Compliance, DHL Supply Chair, Leicester, United Kingdom; Professor B. Meddah, Laboratoire National de Contrôle de Médicaments, Direction du Médicament et de la Pharmacie, Rabat, Morocco; Ms C. Mendy, Director, Scientific and Regulatory Affairs, Global Self-Care Federation, Nyon, Switzerland; Professor V. Merino Sanjuán, Facultad de Farmacia, Valencia, Spain; Dr S. Mielcarek, Good Manufacturing Practice Inspector, Chief Pharmaceutical Inspectorate, Warsaw, Poland; Dr G. Mignot, Saint Paul, France; Ms R.K. Miller, Director of Regulatory Affairs, Parenteral Drug Association, Bethesda (MD), USA; Mr J. Miller, Assistant-Director Scientific Affairs, Parenteral Drug Association, Bethesda (MD), USA; Dr J.H.McB. Miller, Ayr, Scotland; Mr K. Miura, Membrane Sales Department, Daicen Membrane Systems Ltd, Tokyo, Japan; Ms G. Mkomagi, Tanzania Food and Drug Authority, Dar-es-Salaam, United Republic of Tanzania; Mr K. Mochizuki, Chief Executive Officer, Xpro Associates LLC, Yokohama, Japan; Dr N. Modutlwa, Gaborone, Botswana; Dr S. Mogatle, United Nations Population Fund, UN City, Copenhagen, Denmark; Mr B.R. Mohanty, Indus Medicare Ltd, Hyderabad, India; Mr D. Moholkar, Head, Assurance, Natco Pharma Ltd, Dehradun, India; Dr J.A. Molzon, Bethesda (MD), USA; Mr S. Mooney, Senior Regulatory Affairs Specialist, Charles River Laboratories, Wilmington (MA); Dr K. Moore, Manager, Pharmacopeial Harmonization, US Pharmacopeia, Rockville (MD), USA; Ms T. Moore, Medicines and Healthcare Products Regulatory Agency, Good Manufacturing Practice inspector, London, United Kingdom; Mr R. Moorthy, Quascenta Pte Ltd, Singapore; Ms M. Morales Sánchez, Medical Devices and Other Technologies Direction, Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogotá, Colombia; Ms S. P. Morales, Quality Control Director, PiSA Pharmaceutical Co, Guadalajara, Mexico; Dr C. de la Morena Criado, Head of Service, Quality Evaluation, Department of Chemistry and Pharmaceutical Technology, Spanish Agency of Medicines and Medical Devices, Madrid, Spain; Mr M. Multhauf, Consultant Pharmaceutical Engineering, European Compliance Academy Foundation, European Compliance Academy, Heidelberg, Germany; Mr M. Muñoz, Good Manufacturing Practice Coordinator, Grünenthal Chile, Santiago, Chile; Ms M. Muñozcano Quintanar, Comisión Federal para la Protección contra Riesgos Sanitarios, Mexico City, Mexico; Ms C. Munyimba-Yeta, Director Operations (Plant), NRB Pharma Zambia Ltd, Lusaka, Zambia; Mylan Laboratories Ltd, Hyderabad, India; Ms C. Mvurume, Regulatory Officer, Medicines Control Authority, Harare, Zimbabwe; Mr A. Mwipi, Dublin, Ireland; Professor H. Nakagawa, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan; Dr B. Naik, General Manager Technical Services, Mangalam Drugs & Organics Ltd, Vapi, India; Mr K. Nakano, Senior Consultant, Bunzen Co. Ltd, Sagamihara, Japan; Dr N. Nakashima, Senior Director for International Programmes, Associate Centre Director for Asia Training Centre, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Dr P. Nandi, Vice President Global Regulatory Affairs, Laurus Labs, India; Dr C. Nanga, Ministry of Health, Ouagadougou, Burkina Faso; Dr S. Narendran, Assistant Drug Controller, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, New Delhi, India; Professor G. Navas, Professor of Pharmaceutical Analysis, School of Pharmacy, University of Panama, Panamá City, Panama; Ms S. Nazzaro, Senior Program Officer, Product Introduction, Market Dynamics and Access, Bill & Melinda Gates Foundation, Seattle (WA), USA; Ms J. Netterville, Associate Director, AstraZeneca plc, Gaithersburg (MD), USA; Professor A. Nicolas, Paris, France; Dr B. Ning, National Institutes for Food and Drug Control, Beijing, China; Dr J. Norwig, Federal Institute for Drugs and Medical Devices, Bonn, Germany; Mr D. Nti, Food and Drugs Authority, Accra, Ghana; Mr S. Nyamryenchin, Third Secretary, Embassy of Mongolia, Geneva, Switzerland; Dr A. Nyika, Senior Regulatory Officer/Good Manufacturing Practice Inspector, Zazibona Inspections Coordinator, Medicines Control Authority, Harare, Zimbabwe; Dr C. Ogeto, Mission for Essential Medicines and Supplies, Nairobi, Kenya; Mr T. Oi, Deputy Director, Office of the Committee on Oversight of Pharmaceuticals and Medical Devices Safety Regulation, Health Science Division, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Tokyo, Japan; Ms L. P. Ojeda, Head of International Affair Office, Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, Cuba; Mrs A. Ojoo, Technical Specialist, Paediatric Formulations, UNICEF Supply Division, Nordhavn, Copenhagen, Denmark; M.T. Okuwoga, National Agency for Food and Drug Administration and Control, Ajuba, Nigeria; Professor D.W. Oliver, North-West University, Potchefstroom, South Africa; Dr H. Okuda, Deputy Director-General, National Institute of Health Sciences, Tokyo, Japan; Ms A. Olivares, Comisión Federal para la Protección contra Riesgos Sanitarios, Mexico City, Mexico; Dr C. Ondo, Ministry of Health, Bata, Equatorial Guinea; Mr J. Opit, Assistant Assurance Manager, Abacus Parenteral Drugs Ltd, Kampala, Uganda; Mr P. Osatapirat, Thailand Food and Drug Administration, Nonthaburi, Thailand; Mr J.V. Oudtshoorn, South African Health Products Regulatory Authority, South Africa; Ms A. Paavola, Senior Researcher, Finnish Medicines Agency, Helsinki, Finland; Dr N.B. Patel, Assistant Manager, Assurance, Mepro Pharmaceuticals Pvt. Ltd, Surendranagar, India; Mr A. Padua, Assurance, Allergan Sales LLC, Irvine (CA), USA; Mrs L.M. Paleshnuik, LP Inc., Ottawa, Canada; Ms H. Park, Ministry of Drug and Food Safety, Chungcheongbuk-do, Republic of Korea; Dr S. Park, Ministry of Drug and Food Safety, Chungcheongbuk-do, Republic of Korea; Dr S. Parkash, Assistant Vice-President, Regulatory Affairs, Laurus Labs Ltd, Hyderabad, India; Dr S. Parra, Manager, Generic Drugs Quality Division 1, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada; Mr Y Patel, Information Technology Validation Consultant, GC Biotherapeutics Inc., Quebec, Canada; Dr S.R. Srinivas Patnala, Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa; Professor G.M. Pauletti, Associate Dean for Graduate Studies, Gustavus & Henry Pfeiffer Chair, Department of Pharmaceutical and Administrative Sciences, University of Health Sciences & Pharmacy, St Louis College of Pharmacy, St Louis (MI), USA; Mr S.T. Pedersen, Senior Director, External Affairs, Quality Intelligence and Inspection, Novo Nordisk A/S, Bagsværd, Denmark; Dr G. Penzlin, Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany; Dr L. Perez Albela Vera, Pfizer Inc., New York City (NY), USA; Ms C. Planchon, Inspection, Federal Agency for Medicines and Health Products, Brussels, Belgium; Ms T. Poh Suan, Senior Manager, Assurance, Karex, Selangor, Malaysia; Ms S. Polovic, Head of Inspectorate, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Dr A. Porrás, Unit Chief, Medicines and Health Technologies, WHO Regional Office for the Americas, Washington DC, USA; Ms K. Porras, Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, Colombia; Dr W. Potter, Stapleford Scientific Services Ltd, Cambridge, United Kingdom; Mr S. Prasad, General Manager Corporation, Quality Control, Akums Drugs and Pharmaceuticals Ltd, New Delhi, India; Dr S. Pretorius, Research Institute for Industrial Pharmacy Inc., Centre for Quality Assurance of Drugs, Potchefstroom, South Africa; Ms S. Pulido, PiSA Farmacéutica, Guadalajara, Mexico; Ms H. Qorani, Jordan Food and Drug Administration, Amman, Jordan; Ms Z. Raditladi, Manager, Quality Management, Botswana Medicines Regulatory Authority, Gaborone, Botswana; Mrs P. Rafidison, University of Paris, Paris, France; Dr L. Rägo, Secretary-General, Council of International Organizations of Medical Sciences, Geneva, Switzerland; Professor M.A.U. Rahman, Controller (Engineering), AGP Limited, Karachi, Pakistan; Mr C. Ranga, Deputy Drugs Controller (I), Central Drugs Standard Control Organization, New Delhi, India; Ms G. Rao, Aurobindo Pharma Ltd, India; Ms E. Ratkowska, Good Manufacturing Practice Inspector, Chief Pharmaceutical Inspectorate, Warsaw, Poland; Mr K. Rehemtulla, Drug Registration Officer, Tanzania Food and Drugs Authority, United Republic of Tanzania; Mr R. dos Reis, Health Regulatory Agency, Brasília, Brazil; Dr H.K. Remmelt Van Der Werf, European Directorate for the Quality of Medicines and Health Care, Council of Europe, Strasbourg, France; Professor M. Rizzi, University of Piemonte Orientale, Novara, Italy; Dr J.L. Robert, Luxembourg; Mr N. Robert, Chief Executive Officer, Robert Neri Consulting, France; Dr J. Robertson, Hertfordshire, United Kingdom; Professor K. Rocha Rezende, Universidade Federal de Goiás, Faculdade de Farmácia BioPk, Laboratório de Biofarmácia e Farmacocinética, Goiás, Brazil; Ms I. Rodríguez, Comisión para el Control de Calidad de Medicamentos, Montevideo, Uruguay; Dr J. Isasi Rosas, Inspection Services, Centro Nacional de Control de Calidad, Lima, Peru; Mr T. Rücker, General Manager, Letzner Pharmawasseraufbereitung GmbH, Hückeswagen, Germany; Mr R.T. Rukwata, Head of Licensing and Inspection, Medicines Control Authority, Harare, Zimababwe; Dr J. Sabartova, Prague, Czechia; 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; Mr H. Sakurai, Specialist for Inspection, Office of Manufacturing/Quality and Compliance, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Ms K. Salin, Environmental Strategist, Scientific Expertise, Swedish Medical Products Agency, Uppsala, Sweden; Dr A. Salinas Rivera, Institute of Public Health, Santiago, Chile; Dr P. Salo, Head of Pharmaco-Chemical Section, Finnish Medicines Agency, Helsinki, Finland; Sandoz, Mumbai, India; Mr Y. Samson, Director, Kereon AG, Basel, Switzerland; Dr C.A. Sánchez González, Adviser, Centre para el Control de Medicamentos, Equipos y Dispositivos Médicos, Havana, Cuba; Sanofi, Gentilly, France; Sanofi Pasteur, Marcy-l’Étoile, France; Dr B. Santoso, Yogyakarta, Indonesia, Yogyakarta, Indonesia; Ms A. Saragih, Indonesian Pharmacopoeia Commission, National Agency of Drug and Food Control, Yogyakarta, Indonesia; Dr D. Sato, Chief Management Officer, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan; Mr N. Schaaf, Programme Manager, Swedish Water House, Stockholm International Water Institute, Stockholm, Sweden; Dr P.E. Schaeffer, Regulatory Affairs, Regulatory Science and Policy Associate, European Union Region/Asia, Middle East and European Region, Sanofi-Aventis R&D, Chilly-Mazarin, France; Dr S. Schäfermann, Research Associate, Medi-Quality Security Institute, Kanazawa University, Kanazawa, Japan; Dr J. Schläpfer, Head, Sector Management Services and International Affairs, Swissmedic, Bern, Switzerland; Mr J. Screbo, JS International Auditing & Consulting, Stockholm, Sweden; Professor G.K.E. Scriba, Professor, Pharmaceutical Chemistry, Friedrich-Schiller University, Jena, Germany; Mrs P. Serpa, Coordinator, National Sanitary Surveillance Agency, Brasiliía, Brazil; Serum Institute of India, Pune, India; Shanghai Desano Chemical Pharmaceutical Co. Ltd, Shanghai, China; Ms H. Sharma, Manager, Rusan Pharma, Mumbai, India; Professor G. Shashkova, Moscow, Russian Federation; Shenyang Antibiotic, Shenyang, China; J. Shin, Medical Officer, World Health Organization, Geneva, Switzerland; Mrs V. Shridhankar, Cipla Ltd, Mumbai, India; Dr S.C. Shubat, Director, United States Accepted Names Program, American Medical Association, Chicago (IL), USA; Mr S. Shull, Manufacturing Process Engineer IV, Abbvie, Cincinnati (OH), USA; Dr M. Sibutha, Quality Control Manager, Datlabs, Belmont, Zimbabwe; Mr D. Silva, Sindusfarma, Sindicato da Indústria de Produtos Farmacêuticos, São Paulo, Brazil; Dr W.C. Simon, Associate Director, Bureau of Pharmaceutical Sciences, Ottawa, Canada; Dr G.N. Singh, Ghaziabad, India; Dr G.P. Singh, Senior Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, India; Ms I. Šipić, Public Relations Office, Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia; Ms M. Skiba, Good Manufacturing Practice Inspector, Chief Pharmaceutical Inspectorate, Warsaw, Poland; Ms J. Skutnik-Wilkinson, Associate Director, Quality Intelligence, Biogen, Research Triangle Park (NC), USA; Dr L. Smallshaw, Co-Chair, European Compliance Academy Foundation Board, European Compliance Academy, Heidelberg, Germany; Mr D. Smith, Principal Scientist, SSI Schaefer Systems SA, Pretoria, South Africa; Dr D.J. Snodin, Principal, Xiphora Biopharma Consulting, Bristol, United Kingdom; Mrs M. Soares, Brasília, Brazil; Mr T. Spooner, Director, Engineering, Amgen Inc., West Greenwich (RI), USA; Dr Sornakumar, Senior Manager Qulaity Assurance, Sequent Research Ltd, Hyderabad, India; Mr E. Sousa Silva, Health Regulatory Agency, Brasília, Brazil; Dr A. Ssenkindu, National Drug Authority, Kampala, Uganda; Dr L. Stoppa, Inspections and Certifications Department, Manufacturing Authorisation Office, Italian Medicines Agency, Rome, Italy; Dr C. Strnadova, Senior Scientific Advisor, Therapeutic Products Directorate of Health Canada, Ottawa, Canada; Ms Y. Suarez, Health Regulatory Agency, Brasília, Brazil; Dr J. Sun, Deputy Director General Department of Drug and Cosmetics Supervision, China Food and Drug Administration, Beijing, China; Dr D. Sun Cuilian, Deputy Laboratory Director, Pharmaceutical Laboratory, Pharmaceutical Division, Health Sciences Authority, Singapore; Dr P. Svarrer Jakobsen, United Nations Children’s Fund, Supply Division, Copenhagen, Denmark; Ms E. Tack, Directorate General Inspection, Distribution Division, Distribution and Publicity Medicines Entity, Federal Agency for Medicines and Health Products, Brussels, Belgium; Dr A. Terhechte, Bezirksregierung Münster, Bonn, Germany; Ms A. Tiley, Head, Global Sustainable Antibiotics Program, Centrient Pharmaceuticals, Rotterdam, Netherlands; Dr R. Torano, Pharmacopoeial Technical Expert, GlaxoSmithKline, Barnard Castle, United Kingdom; Dr J.M. Trapsida, Niamey, Niger; Mr S. Tripathi, Assurance Head, Rusoma Laboratories Pvt. Ltd, Indore, India; Mr F. Trucco, Ministerio de Salud Pública, Montevideo, Uruguay; TTK Healthcare Ltd, Chennai, India; Mr N. Twitchen, Executive Director, Global Quality Assurance, The Female Health Company (UK), London, United Kingdom; Mr C. Twumasi-Danquah, Food and Drugs Authority, Accra, Ghana; Professor N. Udupa, Research Director, Health Sciences, Manipal Academy of Higher Education, Manipal, India; Dr A.J. Van Zyl, George, South Africa; Dr K. Vashi, Vice-President, Technical Operations, Mangalam Drugs & Organics Ltd, Valsad, India; Dr C.C.F. Vidotti, Ministry of Health, Brasilía, Brazil; Dr O. del Rosario Villalva Rojas, Executive Director, Quality Control Laboratories, National Quality Control Center, National Institute of Health, Lima, Peru; Mr W. Von Kluechtzner, United Nations Industrial Development Organization, Vienna, Austria; Mr A. Walsh, President, Center for Pharmaceutical Cleaning Innovation, Hillsborough (NJ), USA; Ms M. Wanyama, Mission for Essential Drugs and Supplies, Nairobi, Kenya; Mr W. Watson, Senior Director, Gilead Sciences, Cambridge, United Kingdom; Dr P. Weiglmeier, Validation Management and Technical Transfer, Fareva, Feucht, Germany; Dr K. Weisser, Senior Assessor, Paul-Ehrlich-Institut, Langen, Germany; Mr J. Welink, Medicines Evaluation Board, Utrecht, Netherlands; Ms K. Wessberg, Senior Director, Regulatory Affairs, Abbott Park (IL), USA; Professor A. Wessels, North West University, Potchefstroom, South Africa; Dr M. Wiggens, Merck & Co. Inc., Kenilworth (NJ), USA; Mr K. Wilberforce, Directorate of Laboratory Services, National Drug Authority, Kampala, Uganda; Ms C. Winfield, Senior Director, Regulatory Operations, International Society for Pharmacopepidemiology, Bethesda (MD), USA; Dr C. Wirthumer-Hoche, Head, Austrian Medicines and Medical Devices Agency, Vienna, Austria; Ms K. van Wonderen, Health and Youth Care Inspectorate, Ministry of Health, Welfare and Sport, DA Heerlen, The Netherlands; Mr W. Wulandari, Good Manufacturing Practice Inspector, Indonesian Food and Drug Authority, Jakarta Pusat, Indonesia; Dr M. Xu, Deputy Director, Institiute for Chemical Drug Control, China National Institutes for Food and Drug Control, China; Dr T. Yi, National Medical Products Administration, Beijing, China; Dr L.M. Yong, Health Science Authority, Singapore; Dr J. Zhang, Guangzhou Institute for Drug Control, Guangzhou, China; Zhejiang Jiangbei Pharmaceutical Co. Ltd, Zhejiang, China.