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202 documentos en 5 páginas
 
cerrar esta sección de la bibliotecaQuality and Safety: Medicines
cerrar esta sección de la bibliotecaRegulatory Support
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Título: 13th International Conference of Drug Regulatory Authorities (ICDRA) Berne, Switzerland, 16-19 September 2008. ICDRA: Medicines Agencies Decide Future Action
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2008 Páginas: 19
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regiones: Global
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Título: 14th International Conference of Drug Regulatory Authorities(ICDRA), Singapore 30 November - 3 December 2010
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2011 Páginas: 16
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
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Título: 15th International Conference of Drug Regulatory Authorities (ICDRA), Tallinn, Estonia, 23–26 October 2012
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2012 Páginas: 23
Publicadores:
WHO Headquarters in Geneva
Enlaces relacionados:
http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en/index.html
Regiones: Global
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Título: The Ability of Select Sub-Saharan African Countries to Utilise Trips Flexibilities and Competition Law to Ensure a Sustainable Supply of Essential Medicines: A Study of Producing and Importing Countries
Temas: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Regulatory Support
Autore: Avafia, Tenu; Berger, Jonathan; Hartzenberg, Trudi
Año: 2006 Páginas: 59
Publicadores:
United Nations Conference on Trade and Development (UNCTAD )
Trade law centre for southern Africa (TRALAC)
Regiones: África (AFRO); SSA Sub-Saharan Africa
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Título: Access to ART and other Essential Medicines in Sub-Saharan Africa: Intellectual Property and Relevant Legislations, September 2007
Temas: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Regulatory Support
Autore: Musungu, Sisule F.
Año: 2007 Páginas: 37
Publicadores:
United Nations Development Programme (UNDP)
Regiones: África (AFRO); SSA Sub-Saharan Africa
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Título: Access to Medicines and Drug Regulation in Developing Countries: A Resource Guide for DFID
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Autore: Gray, Andy
Año: 2004 Páginas: 16
Publicadores:
DFID Health Resource Centre
Regiones: Global
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Título: Act 234 - Dangerous Drugs Act 1952 (Revised 1980). Incorporating Latest Amendment - P.U.(A) 44 /2003 - Malaysia
Temas: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Regulatory Support
Año: 2003 Páginas: 55
Publicadores:
Malaysia Ministry of Health
Países: Malasia
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Título: Act 368 - Sale of Drugs Act 1952 (Revised 1989). Incorporating Latest Amendment - Act A1084/2000
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2000 Páginas: 11
Publicadores:
Malaysia Ministry of Health, Pharmaceutical Services Division
Países: Malasia
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Título: African Medicines Registration Harmonisation (AMRH) Initiative: Summary, Status and Future Plans. The New Partnership for Africa’s Development (NEPAD) & the World Health Organization (WHO)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2009 Páginas: 13
Publicadores:
WHO Headquarters in Geneva
NEPAD - The New Partnership for Africa's Development / African Union (AU)
Enlaces relacionados:
http://www.afro.who.int/en/clusters-a-programmes/hss/essential-medicines/edm-publications.html
Regiones: África (AFRO)
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Título: Analysis of Legal Aspects of Local Pharmaceutical Production in Rwanda
Temas: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2006 Páginas: 54
Publicadores:
German Technical Cooperation Agency (GTZ) / Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ) GmbH
Países: Rwanda
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Título: Annual Report of Pharmacy Council, March 2010 - March 2011 - St. Vincent and the Grenadines.
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2010 Páginas: 8
Publicadores:
St. Vincent and the Grenadines, Ministry of Health & the Environment
Países: San Vicente y las Granadinas
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Título: Antibiotics Act - Trinidad and Tobago
Temas: Medicine Access and Rational Use > Antimicrobial Drug Resistance
Quality and Safety: Medicines > Regulatory Support
Año: 2007 Páginas: 40
Publicadores:
Ministry of Legal Affairs - Trinidad and Tobago
Países: Trinidad y Tobago
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Título: Application for Marketing Authorization of a Pharmaceutical Product - Maldives Food and Drug Authority
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2006 Páginas: 5
Publicadores:
Republic of Maldives, Ministry of Health & Family
Países: Maldivas
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Título: Application of Hazard Analysis and Critical Control Point (HACCP) Methodology to Pharmaceuticals. WHO Technical Report Series, No. 908, 2003, Annex 7
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2003 Páginas: 14
Publicadores:
WHO Headquarters in Geneva
Regiones: Global
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Título: Assessment of Medicine Quality Assurance in Rwanda: Overview of Findings and Recommendations for Consideration. Kigali and Butare, Rwanda, November 9-13, 2009
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Autore: Coignez, Veerle; Hajjou, Mustapha; Smine, Abdelkrim
Año: 2009 Páginas: 20
Publicadores:
United States Pharmacopeia (USP)
USAID - Promoting the Quality of Medicines Program (PQM)
Países: Rwanda
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Título: Assessment of Medicines Regulatory Systems in Sub-Saharan African Countries. An Overview of Findings from 26 Assessment Reports
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2010 Páginas: 48
Publicadores:
WHO Headquarters in Geneva
Regiones: África (AFRO)
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Título: ATOME Scan of National Legislation. Results of the Quick Scan of National Legislation of Twelve European Countries (Work Package 7). ATOME (Access to Opioid Medication in Europe)
Temas: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Regulatory Support
Autore: Mantel-Teeuwisse, Aukje K.; Schutjens, Marie‐Hélène; Vranken, Marjolein
Año: 2012 Páginas: 6
Publicadores:
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Regiones: Europa (EURO); EU European Union
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Título: Bill to Provide for the Establishment of Drug Regulatory Authority of Pakistan, 2012
Temas: Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 28
Publicadores:
Pakistan Government
Países: Pakistán
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Título: Biosimilars. A Unique Opportunity for Iran National Health Sector and National Pharmaceutical Industry
Temas: Medicine Information and Evidence for Policy > Medicines Policy
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Autore: Cheraghali, Abdol Majid
Año: 2012 Páginas: 4
Documentos relacionados:
Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, 19-23 October 2009
Enlaces relacionados:
http://www.darujps.com/content/20/1/35
Países: Irán (República Islámica del)
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Título: Code of Conduct - COC. Pharmig Code of Conduct and Code of Procedures of the COC Committes of Experts of the 1st and 2nd Instance. Coming into force on 01/07/2007, Last amendment on 01/07/2009 (Austria)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2009 Páginas: 43
Publicadores:
Pharmig – Association of the Austrian Pharmaceutical Industry
Países: Austria
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Título: Combating Counterfeit, Falsified and Substandard Medicines: Defining the Way Forward? Chatham House Briefing Paper, November 2010
Temas: Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Autore: Clift, Charles
Año: 2010 Páginas: 16
Publicadores:
Chatham House (the Royal Institute of International Affairs) - Centre on Global Health Security
Regiones: Global
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Título: COMMISSION REGULATION (EC) - No. 1277/2005 of 27 July 2005 Laying Down Implementing Rules for Regulation (EC) - No. 273/2004 of the European Parliament and of the Council on Drug Precursors and for Council Regulation (EC) - No. 111/2005 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Temas: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Regulatory Support
Año: 2005 Páginas: 27
Publicadores:
European Union (EU)
Regiones: EU European Union
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Título: COMMISSION REGULATION (EC) - No. 297/2009 of 8 April 2009 Amending Regulation (EC) - No. 1277/2005 Laying Down Implementing Rules for Regulation (EC) - No. 273/2004 of the European Parliament and of the Council on Drug Precursors and for Council Regulation (EC) - No. 111/2005 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Temas: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Regulatory Support
Año: 2009 Páginas: 3
Publicadores:
European Union (EU)
Regiones: EU European Union
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Título: Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments, Fourteenth Issue (New data only) (January 2005 – October 2008)- Pharmaceuticals. United Nations – New York, 2009
Temas: Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Año: 2009 Páginas: 94
Publicadores:
United Nations (UN)
Regiones: Global
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Título: Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue - Pharmaceuticals. United Nations - New York, 2005
Temas: Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Año: 2005 Páginas: 598
Publicadores:
United Nations (UN)
Regiones: Global
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Título: Cosmetics, Devices and Drugs Act, No. 27 of 1980. Part I: Section (I) - General. The Gazette of the Democratic Socialist Republic of Sri Lanka, 378/3 - 1985
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 1985 Páginas: 50
Publicadores:
Sri Lanka Ministry of Healthcare and Nutrition
Países: Sri Lanka
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Título: COUNCIL REGULATION (EC) - No. 111/2005 of 22 December 2004 Laying Down Rules for the Monitoring of Trade between the Community and Third Countries in Drug Precursors
Temas: Medicine Access and Rational Use > Controlled Medicines
Quality and Safety: Medicines > Regulatory Support
Año: 2005 Páginas: 10
Publicadores:
European Union (EU)
Regiones: EU European Union
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Título: Criteria and Procedure of Drug Registration. Decree Number: HK.00.05.3.1950 - Indonesia
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2003 Páginas: 21
Publicadores:
Indonesia - National Agency of Drug and Food Control
Países: Indonesia
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Título: Developing World: Bring Order to Unregulated Health Markets
Temas: Quality and Safety: Medicines > Regulatory Support
Autore: Bloom, Gerald; Peters, David H
Año: 2012 Páginas: 3
Regiones: Global
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Título: DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use (OJ L 311, 28.11.2001, p. 67)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2001 Páginas: 126
Publicadores:
European Union (EU)
Regiones: EU European Union
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Título: DIRECTIVE 2005/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the Recognition of Professional Qualifications
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2005 Páginas: 121
Publicadores:
European Union (EU)
Regiones: EU European Union
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Título: Drug Registration Guidance Document, April 2011 Revision
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2011 Páginas: 231
Publicadores:
Malaysia - National Pharmaceutical Control Bureau (NPCB)
Países: Malasia
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Título: Drug Regulation: History, Present and Future. In: van Boxtel CJ, Santoso B, Edwards IR eds., Drug Benefits and Risks: International Textbook of Clinical Pharmacology, Revised 2nd Ed. (Chapter 6). IOS Press and Uppsala Monitoring Centre, 2008
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Autore: Rägo, L; Santoso, Budiono
Año: 2008 Páginas: 13
Regiones: Global
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Título: Drug Seller Initiatives. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 32)
Temas: Medicine Information and Evidence for Policy > Medicines Policy
Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Regulatory Support
Autore: Clark, Malcolm; Heltzer, Ned; Johnson, Keith; Staley, Robert
Año: 2012 Páginas: 15
Publicadores:
Management Sciences for Health (MSH)
Documentos relacionados:
MDS-3: Managing Access to Medicines and Health Technologies (Third Edition)
Enlaces relacionados:
http://www.msh.org/resource-center/mds-3-digital-edition.cfm
Regiones: Global
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Título: The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 (Pakistan)
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 1976 Páginas: 10
Publicadores:
Pakistan Government
Países: Pakistán
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Título: Drugs (Import & Export) Rules, 1976 (Pakistan)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 1976 Páginas: 26
Publicadores:
Pakistan Government
Países: Pakistán
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Título: Drugs Act - Law of Mongolia, Ulaanbaatar, 7 May 1998
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2002 Páginas: 9
Publicadores:
Mongolia - State Great Hural (Parliament of Mongolia)
Países: Mongolia
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Título: Drugs Act, 1976. Advertising of Drugs, Etc. (Pakistan)
Temas: Medicine Access and Rational Use > Rational Use
Quality and Safety: Medicines > Regulatory Support
Año: 1976 Páginas: 4
Publicadores:
Pakistan Government
Países: Pakistán
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Título: Drugs Act, 2035, (1978). Act Number 21 of the Year 2053, 1978 (25 October 1978). An Act Made to Make Provisions Relating to Drugs - Nepal
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 1978 Páginas: 15
Publicadores:
Nepal Government
Países: Nepal
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Título: The Drugs and Cosmetics Act and Rules. the Drugs and Cosmetics Act, 1940 (23 of 1940) (As Amended Up to the 30th June, 2005) and the Drugs and Cosmetics Rules, 1945 (As Amended Up to the 30th June, 2005)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2005 Páginas: 553
Publicadores:
India Ministry of Health & Family Welfare
Enlaces relacionados:
http://pharmaceuticals.gov.in/
Países: India
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Título: Drugs Registration Rules, 2038 (1981). (Publication in Nepal Gazette, 3 Aug. 1981)
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 1981 Páginas: 41
Publicadores:
Nepal Government
Países: Nepal
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Título: Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance Ver el documento en el formato PDF
Temas: Quality and Safety: Medicines > Regulatory Support
Autore: Ratanawijitrasin, Sauwakon; Wondemagegnehu, Eshetu
Año: 2002 Páginas: 187
Publicadores:
WHO Headquarters in Geneva
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Título: Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality - WHO Policy Perspectives on Medicines, No. 007, November 2003 [French] [Spanish] Ver el documento en el formato PDF
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2003 Páginas: 6
Publicadores:
WHO Headquarters in Geneva
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Título: Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Año: 2007 Páginas: 207
Publicadores:
United States Agency for International Development (USAID)
United States Pharmacopeia (USP)
Regiones: Global
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Título: Essential Drugs and Registration of Pharmaceuticals: The Sri Lankan Experience
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 1993 Páginas: 7
Publicadores:
WHO Headquarters in Geneva
Países: Sri Lanka
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Título: Establishment of Statutory Drug Regulation in Developing Countries
Temas: Quality and Safety: Medicines > Regulatory Support
Autore: Fallet, Patrick
Año: 1983 Páginas: 10
Publicadores:
WHO Headquarters in Geneva
Regiones: Global
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Título: Eye on the Ball. Medicine Regulation – Not IP Enforcement – Can Best Deliver Quality Medicines
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2011 Páginas: 51
Publicadores:
Oxfam
Regiones: Global
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Título: FIP Statement of Policy on Counterfeit Medicines [French] [Spanish]
Temas: Medicine Information and Evidence for Policy > Medicines Policy
Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Año: 2003 Páginas: 4
Publicadores:
International Pharmaceutical Federation - FIP
Enlaces relacionados:
http://www.fip.org/statements
Regiones: Global
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Título: FIP Statement of Professional Standards - Code of Ethics for Pharmacist [French] [Spanish]
Temas: Medicine Information and Evidence for Policy > Medicines Policy
Medicine Programme Coordination > Human Resources for Pharmaceutical Sector
Quality and Safety: Medicines > Regulatory Support
Año: 2004 Páginas: 2
Publicadores:
International Pharmaceutical Federation - FIP
Enlaces relacionados:
http://www.fip.org/statements
Regiones: Global
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Título: First African Medicines Regulatory Authorities Conference - Final Report. Addis Ababa, Ethiopia, 31 October – 3 November 2005
Temas: Quality and Safety: Medicines > Regulatory Support
Año: 2009 Páginas: 50
Publicadores:
World Health Organization - Regional Office for Africa (WHO/AFRO)
Regiones: África (AFRO)
 
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