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Quality and Safety: Medicines

Safety and Efficacy

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Titre:	Access to Medicines and Drug Regulation in Developing Countries: A Resource Guide for DFID
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Gray, Andy
An:	2004 Pages: 16
Éditeurs:	DFID Health Resource Centre
Régions:	Global

Titre:	Adverse Reaction Reporting Form (Pakistan)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Pages:	2
Éditeurs:	Pakistan Ministry of Health
Pays:	Pakistan

Titre:	Assessment of Pharmacovigilance and Medicine Safety System in Rwanda, July 2009
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Joshi, Mohan P.; Nwokike, Jude
An:	2009 Pages: 50
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS)
Pays:	Rwanda

Titre:	Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch (July 2003 – Amended 31 May 2005)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2005 Pages: 22
Éditeurs:	Australian Government - Department of Health and Ageing
Pays:	Australie

Titre:	The Burden of Adverse Events During Treatment of Drug-resistant Tuberculosis in Namibia - Southern Med Review Vol 5 Issue 1 July 2012
Sujets:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Dhliwayo, Panganai; Mantel-Teeuwisse, Aukje K.; Musasa, Jean Paul; Pal, Shanthi; Ruswa, Nunurai; Sagwa, Evans; van Wyk, Brian
An:	2012 Pages: 8
Pays:	Namibie

Titre:	Clinical Pharmacology in Health Care, Teaching and Research
Sujets:	Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Safety and Efficacy
An:	2012 Pages: 80
Éditeurs:	WHO Headquarters in Geneva Council for International Organizations of Medical Sciences (CIOMS) International Union of Basic and Clinical Pharmacology (IUPHAR)
Régions:	Global

Titre:	Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments, Fourteenth Issue (New data only) (January 2005 – October 2008)- Pharmaceuticals.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
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 94
Éditeurs:	United Nations (UN)
Régions:	Global

Titre:	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
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2005 Pages: 598
Éditeurs:	United Nations (UN)
Régions:	Global

Titre:	The Drugs (Research) Rules, 1978 (Pakistan)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	1978 Pages: 8
Éditeurs:	Pakistan Government
Pays:	Pakistan

Titre:	Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2007 Pages: 207
Éditeurs:	United States Agency for International Development (USAID) United States Pharmacopeia (USP)
Régions:	Global

Titre:	FIP Statement of Policy - The Role of the Pharmacist in Pharmacovigilance [French] [Spanish]
Sujets:	Medicine Information and Evidence for Policy > Medicines Policy Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Safety and Efficacy
An:	2006 Pages: 4
Éditeurs:	International Pharmaceutical Federation - FIP
Liens associés:	http://www.fip.org/statements
Régions:	Global

Titre:	Good Clinical Practice Regulations, 2009. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 20
Éditeurs:	Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Pays:	Nigéria

Titre:	Good Laboratory Practice Regulations, 2008. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2008 Pages: 23
Éditeurs:	Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Pays:	Nigéria

Titre:	Good Pharmacovigilance Practice Regulations 2009. Nigeria National Agency for Food and Drug Administration and Control (NAFDAC) Act 1993 (as amended)
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 4
Éditeurs:	Nigeria Ministry of Health - National Agency for Food and Drug Administration and Control (NAFDAC)
Pays:	Nigéria

Titre:	Guide to Adverse Reaction Reporting - New Zealand
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Pages:	3
Éditeurs:	Centre for Adverse Reactions Monitoring (CARM) - New Zealand
Pays:	Nouvelle-Zélande

Titre:	Guideline on Medication Error Reporting, First Edition, July 2009 - Malaysia
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 30
Éditeurs:	Malaysia Ministry of Health
Pays:	Malaisie

Titre:	Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia. Fifth Edition (Version 3.1), June 2009
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 58
Éditeurs:	Malaysia - National Pharmaceutical Control Bureau (NPCB)
Pays:	Malaisie

Titre:	Guidelines for Monitoring and Reporting Adverse Drug Reactions (ADRs). (Made Under Section 5 (C) of the Tanzania Food, Drugs and Cosmetics Act, 2003)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2006 Pages: 33
Éditeurs:	Tanzania Food and Drugs Authority (TFDA)
Pays:	Tanzanie

Titre:	Guidelines for Product Recall and Product Withdrawal - Kenya. First Edition, June 2006
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2006 Pages: 18
Éditeurs:	Kenya Ministry of Health - Pharmacy and Poisons Board
Pays:	Kenya

Titre:	Guidelines for the Conduct of Clinical Trials - Uganda National Drug Authority
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2008 Pages: 44
Éditeurs:	Uganda - National Drug Authority (NDA), Ministry of Health
Pays:	Ouganda

Titre:	Guidelines for the National Pharmacovigilance System in Kenya. February 2009, Second Edition
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 46
Éditeurs:	Kenya - Ministry for Medical Services Kenya - Ministry of Public Health and Sanitation
Pays:	Kenya

Titre:	Guidelines for the Pharmacovigilance on Safety of Vaccines in Malaysia
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Pages:	6
Éditeurs:	Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)
Pays:	Malaisie

Titre:	Impact of Pharmacist Recruitment on ADR Reporting: Malaysian Experience - Southern Med Review Vol 4 Issue 2 Dec 2011
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Hadi, Muhammad Abdul; Ming, Long Chiau
An:	2011 Pages: 2
Éditeurs:	Southern Med Review
Pays:	Malaisie

Titre:	Implementing Pharmacovigilance in Suriname, 2006-2009
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 28
Éditeurs:	Suriname, Ministry of Health
Pays:	Suriname

Titre:	The Importance of Medicines Safety - Southern Med Review Vol 5 Issue 1 July 2012
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Kiani, Ayyaz
An:	2012 Pages: 2
Éditeurs:	Southern Med Review
Liens associés:	http://southernmedreview.org
Régions:	Global

Titre:	Is it Justified to let Medicines Fly Without a Black Box? - Southern Med Review Vol 3 Issue 2 Oct 2010
Sujets:	Medicine Information and Evidence for Policy > Information and Publications Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Leufkens, Hubert G
An:	2010 Pages: 1
Régions:	Global

Titre:	Malaysian Guidelines for Good Clinical Practice
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2004 Pages: 88
Éditeurs:	Malaysia Ministry of Health
Pays:	Malaisie

Titre:	Ministerial Ordinance on Good Clinical Practice for Drugs. Ordinance of the Ministry of Health and Welfare No. 28 of March 27, 1997. (As Last Amended by the Ordinance of Ministry of Health, Labour and Welfare No. 68 of March 31, 2009)
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 47
Éditeurs:	Japan - Ministry of Health, Labour and Welfare (MHLW)
Pays:	Japon

Titre:	Monitoring Adverse Drug Reactions in the Public Health Programs: The Case of the Nigeria TB Program
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Nwokike, Jude
An:	2008 Pages: 50
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health (MSH) Tuberculosis Control Assistance Program (TBCAP)
Pays:	Nigéria

Titre:	National Pharmaceutical Control Bureau, Annual Report 2009 - Malaysia
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2010 Pages: 97
Éditeurs:	Malaysia - National Pharmaceutical Control Bureau (NPCB)
Pays:	Malaisie

Titre:	National Pharmacovigilance Systems: Ensuring the Safe Use of Medicines. August 16–18, 2010 Nairobi, Kenya
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2010 Pages: 13
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health (MSH)
Régions:	Afrique (AFRO)

Titre:	PhAMA Code of Conduct for Non Prescription (OTC) Products - Malaysia
Sujets:	Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2008 Pages: 7
Éditeurs:	Pharmaceutical Association of Malaysia (PhAMA) / Persatuan Farmaseutikal Malaysia
Pays:	Malaisie

Titre:	Pharmacovigilance Guidance for Countries Participating in AMFm Phase 1. (WHO-MMV Joint Technical Consultation on Active Pharmacovigilance Monitoring With a Special Focus on AMFm. Geneva, 4-6 April 2009, International Center Cointrin)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 20
Éditeurs:	WHO Headquarters in Geneva Medicines for Malaria Venture (MMV)
Régions:	Global

Titre:	Pharmacovigilance Guidelines. Second Edition, November 2009 - Botswana
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 10
Éditeurs:	Botswana - Ministry of Health Enclave, Drug Regulatory Unit
Pays:	Botswana

Titre:	Pharmacovigilance in Ghana: A Systems Analysis, April 2010
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Eghan, Kwesi; Nwokike, Jude
An:	2010 Pages: 66
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS)
Pays:	Ghana

Titre:	Pharmacovigilance in Rwanda: A Systems Analysis
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Joshi, Mohan P.; Nwokike, Jude
An:	2009 Pages: 32
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS)
Pays:	Rwanda

Titre:	Pharmacovigilance. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 35)
Sujets:	Medicine Information and Evidence for Policy > Medicines Policy Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Olson, Christopher
An:	2012 Pages: 19
Éditeurs:	Management Sciences for Health (MSH)
Documents similaires:	MDS-3: Managing Access to Medicines and Health Technologies (Third Edition)
Liens associés:	http://www.msh.org/resource-center/mds-3-digital-edition.cfm
Régions:	Global

Titre:	A Poor-quality Generic Drug for the Treatment of Visceral Leishmaniasis: A Case Report and Appeal
Sujets:	Medicine Access and Rational Use > Supply Management Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Beijnen, Jos H.; de Vries, Peter J.; Dorlo, Thomas P. C.; Eggelte, Teunis A.; Schoone, Gerard J.
An:	2012 Pages: 4
Régions:	Global
Pays:	Bangladesh

Titre:	Profile of Services, 2010 (Pharmaceuticals and Medical Devices Agency, PMDA - Japan)
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2010 Pages: 36
Éditeurs:	Japan - Pharmaceuticals and Medical Devices Agency
Pays:	Japon

Titre:	Protocol for National Pharmacovigilance Programme for Ayurveda, Siddha and Unani (ASU) Drugs, 2008
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2008 Pages: 73
Éditeurs:	India Ministry of Health & Family Welfare
Pays:	Inde

Titre:	REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 Laying Down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2004 Pages: 33
Éditeurs:	European Union (EU)
Régions:	EU European Union

Titre:	Report of Adverse Reactions to Medicines, Vaccines, Devices, Traditional Remedies & Cosmetics (Sri Lanka)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Éditeurs:	Sri Lanka Ministry of Healthcare and Nutrition
Pays:	Sri Lanka

Titre:	SADC Guidelines for Bioavailability and Bioequivalence, 2007
Sujets:	Quality and Safety: Medicines > Quality Assurance Quality and Safety: Medicines > Safety and Efficacy
An:	2007 Pages: 26
Éditeurs:	SADC - Southern African Development Community
Régions:	Afrique (AFRO); CEMAC Communauté économique et monétaire de l'Afrique Centrale; EAC East African Community; SADC Southern African Development Community

Titre:	Safe and Effective: Use of Antiretroviral Treatments in Adults with Particular Reference to Resource Limited Settings [French]
Sujets:	Medicine Access and Rational Use > Rational Use Quality and Safety: Medicines > Safety and Efficacy
An:	2001 Pages: 36
Éditeurs:	WHO Headquarters in Geneva Joint United Nations Programme on HIV/AIDS (UNAIDS) International AIDS Society (IAS)
Régions:	Global

Titre:	Safety of Medicine in Sub-saharan Africa. Assessment of Pharmacovigilance Systems and Their Performance
Sujets:	Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
An:	2012 Pages: 143
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS)
Régions:	Afrique (AFRO); SSA Sub-Saharan Africa

Titre:	Situation Analysis of the Pharmacovigilance Capacity of Kenya, Tanzania, Uganda (Draft, November 2007)
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Lalvani, Paul S
An:	2007 Pages: 32
Régions:	Afrique (AFRO)
Pays:	Kenya; Ouganda; Tanzanie

Titre:	Starting a Pharmacovigilance Program within a Teaching Hospital: Challenges and Experiences from Lalitpur, Nepal - Southern Med Review
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Bajracharya, Omi; Jha, Nisha; Shankar, Pathiyil Ravi; Shrestha, Rojeena; Thapa, Harish Singh
An:	2009 Pages: 4
Pays:	Népal

Titre:	Strategies to Increase the Number Clinical Trials That Are Recruiting Children in India Registered on the Clinical Trials Registry-India (CTRI)
Sujets:	Medicine Access and Rational Use > Better Medicines for Children Quality and Safety: Medicines > Regulatory Support Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Tharyan, Prathap
An:	2009 Pages: 154
Éditeurs:	India - Christian Medical College, Vellore South Asian Cochrane Network & Centre
Pays:	Inde

Titre:	Supporting Pharmacovigilance in Developing Countries. The Systems Perspective
Sujets:	Quality and Safety: Medicines > Safety and Efficacy
An:	2009 Pages: 24
Éditeurs:	United States Agency for International Development (USAID) Management Sciences for Health, Strengthening Pharmaceutical Systems (MSH/SPS)
Régions:	Global

Titre:	Traditional and Complementary Medicines: Quality Assessment Strategies and Safe Usage - Southern Med Review
Sujets:	Traditional Medicine > Traditional, Complementary and Herbal Medicine Quality and Safety: Medicines > Safety and Efficacy
Auteur:	Hussain, Khalid; Ibrahim, Pazilah; Ismail, Zhari; Majeed, Muhammad Tahir; Sadikun, Amirin
An:	2009 Pages: 5
Régions:	Global


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Dernière mise à jour: le 3 mai 2013