WHO Expert Committee on the Selection and Use of Essential Medicines's Books

The Selection and Use of Essential Medicines

Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).

By: WHO Expert Committee on the Selection and Use of Essential Medicines,World Health Organization

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The Selection and Use of Essential Medicines

Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).

By: WHO Expert Committee on the Selection and Use of Essential Medicines,World Health Organization

The 19th Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicine took place in Geneva, Switzerland, from 8 to 12 April 2013"--P. vii.

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235

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World Health Organization

Published Date

ISBN 10

9241209852

ISBN 13

9789241209854

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-eighth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-eighth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

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401

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World Health Organization

Published Date

ISBN 10

9241209860

ISBN 13

9789241209861

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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374

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World Health Organization

Published Date

ISBN 10

9241209968

ISBN 13

9789241209960

The Selection and Use of Essential Medicines

Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).

By: WHO Expert Committee on the Selection and Use of Essential Medicines,World Health Organization

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The Selection and Use of Essential Medicines

Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).

By: WHO Expert Committee on the Selection and Use of Essential Medicines,World Health Organization

The 19th Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicine took place in Geneva, Switzerland, from 8 to 12 April 2013"--P. vii.

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235

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World Health Organization

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ISBN 10

9241209852

ISBN 13

9789241209854

WHO Expert Committee on Drug Dependence

Thirty-fifth Report

By: WHO Expert Committee on Drug Dependence,World Health Organization

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WHO Expert Committee on Drug Dependence

Thirty-fifth Report

By: WHO Expert Committee on Drug Dependence,World Health Organization

This report presents the recommendations of a WHO Expert Committee responsible for reviewing information on psychoactive substances to assess the need for their international control. The report contains a summary of the Committee's evaluations of y-hydroxybutyric acid (GHB) and ketamine. GHB was recommended to be rescheduled from Schedule IV to Schedule II of the Convention on Psychotropic Substances. The report also discusses the nine substances that were prereviewed: dextromethorphan, tapentadol, N-benzylpiperazine (BZP), 1-(3-trifluoromethylphenyl)piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP), 1-(4-methoxyphenyl) piperazine (MeOPP), 1-(3,4-methylenedioxybenzyl)piperazine (MDBP), y-butyrolactone (GBL), and 1,4-butanediol (1,4-BD). Of these, tapentadol, BZP, GBL and 1,4-BD were recommended for critical review. Issues identified for consideration at future Expert Committee meetings are also listed. Furthermore, the report discusses the use of terms, the use of pharmacovigilance data for the assessment of abuse and dependence potential, balancing medical availability and prevention of abuse of medicines manufactured from controlled substances, and improving the process for substance evaluation.

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ISBN 10

9241209739

ISBN 13

9789241209731

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

By: World Intellectual Property Organization,World Health Organisation (WHO),World Trade Organisation (WTO)

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Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

By: World Intellectual Property Organization,World Health Organisation (WHO),World Trade Organisation (WTO)

This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.

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352

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WIPO

Published Date

ISBN 10

9280531743

ISBN 13

9789280531749

Who Expert Committee on Drug Dependence

Thirty-seventh Report

By: WHO Expert Committee on Drug Dependence. Meeting,World Health Organization

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Who Expert Committee on Drug Dependence

Thirty-seventh Report

By: WHO Expert Committee on Drug Dependence. Meeting,World Health Organization

The WHO Expert Committee on Drug Dependence (ECDD) is responsible for assessing psychoactive substances for possible control under the international drug control conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm potential of each substance under review. After the ECDD advises the Director-General of WHO as to whether to schedule or to amend the scheduling status of a substance, the Director-General will, as appropriate, communicate the recommendations to the United Nations Secretary-General. The Secretary-General communicates the advice to the Commission on Narcotic Drugs (CND), as appropriate. This report presents the recommendations of the thirty-seventh meeting of the WHO Expert Committee on Drug Dependence. The report summarizes the review of nine substances and the ECDD's recommendations for the scheduling of seven substances. The report also provides updates on ketamine and cannabis, as requested by resolutions of the Commission on Narcotic Drugs. It contains updates on the work of international bodies concerned with controlled substances, as well as summaries of the follow-up discussions on recommendations made at the previous ECDD meeting, and on the discussions on criteria for assessing new psychoactive substances and on terminology.

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World Health Organization

Published Date

ISBN 10

9241209984

ISBN 13

9789241209984

The Selection and Use of Essential Medicines

By: WHO Expert Committee on the Selection and Use of Essential Medicines

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The Selection and Use of Essential Medicines

By: WHO Expert Committee on the Selection and Use of Essential Medicines

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.

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Page Count

142

Publisher

Diamond Pocket Books (P) Ltd.

Published Date

ISBN 10

9241209208

ISBN 13

9789241209205

WHO Expert Committee on Biological Standardization

Sixty-Third Report

By: WHO Expert Committee on Biological Standardization. Meeting,World Health Organization

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WHO Expert Committee on Biological Standardization

Sixty-Third Report

By: WHO Expert Committee on Biological Standardization. Meeting,World Health Organization

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated); recombinant malaria vaccines; diphtheria vaccines (adsorbed); tetanus vaccines (adsorbed); combined vaccines based on diphtheria and tetanus vaccines; and Japanese encephalitis vaccines (live, attenuated). Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of vaccines and related substances; blood products and related substances; in vitro diagnostic device reagents; biotherapeutics other than blood products; and antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8.

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507

Publisher

World Health Organization

Published Date

ISBN 10

9241209801

ISBN 13

9789241209809

Selection and Use of Essential Medicines (The) (RUSSIAN)

Report of the WHO Expert Committee 2011(including the 17th WHO Model List of Essential Medicines and the 3rd WHO Model List for Children)

By: WHO

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Selection and Use of Essential Medicines (The) (RUSSIAN)

Report of the WHO Expert Committee 2011(including the 17th WHO Model List of Essential Medicines and the 3rd WHO Model List for Children)

By: WHO

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. It contains a summary of the Committee s considerations and justifications for additions and changes to the Model Lists including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (17th edition) and the WHO Model List of Essential Medicines for Children (3rd edition). In addition there is a list of all the items on the Model Lists sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes. An additional annex covers the Report of a Supplementary Meeting of the Expert Committee on the Selection and Use of Essential Medicines which took place in Geneva in January 2010 to consider treatment of the pandemic influenza virus.

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325

Publisher

World Health Organization

Published Date

ISBN 10

9244209659

ISBN 13

9789244209653

The Use of Essential Drugs

Ninth Report of the WHO Expert Committee (including the Revised Model List of Essential Drugs).

By: World Health Organization

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The Use of Essential Drugs

Ninth Report of the WHO Expert Committee (including the Revised Model List of Essential Drugs).

By: World Health Organization

Essential drugs are those that satisfy the health care needs of the majority of the population and should be readily available at an affordable price. This publication contains the WHO eleventh Model List of Essential Drugs. The report also covers such issues as the selection of essential drugs, pharmaceutical dosage forms and drug utilisation studies.

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ISBN 10

9241208953

ISBN 13

9789241208956

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-ninthReport

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-ninthReport

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP) and was informed of progress achieved with developing a comprehensive document on GPhP through discussions at consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP) distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project. The report includes the following annexes which are recommended as new WHO guidelines: . Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); . Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); . Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non-sterile process validation (revision); . Annex 4. General guidance for inspectors on hold-time studies (new); . Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); . Annex 7. Guidelines on registration requirements to establish interchangeability (revision); . Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); . Annex 9: Good review practices guidelines for regulatory authorities (new). In addition 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5). The newly adopted monographs were adopted for inclusion in The International Pharmacopoeia. Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification together with related updates to relevant monographs. The Committee adopted 12 ICRS newly characterized by the custodian centre EDQM. The Committee further adopted the workplan for new monographs to be included in The International Pharmacopoeia.

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224

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World Health Organization

Published Date

ISBN 10

9241209925

ISBN 13

9789241209922

Who Expert Committee on Specifications for Pharmaceutical Preparations

Forty-seventh Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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Who Expert Committee on Specifications for Pharmaceutical Preparations

Forty-seventh Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

WHO's international guidelines, written and physical standards developed under the aegis of this Expert Committee for more than 60 years are designed to serve all Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, and underpin important initiatives, including the prequalification of medicines, the Roll Back Malaria Programme, Stop TB, essential medicines and medicines for children. The Forty-seventh WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted 26 new monographs and general texts for inclusion in The International Pharmacopoeia,/I>. The specifications under development are internationally applicable test methodologies for anti-infective, antimalarial, antituberculosis, contraceptives and antiretroviral medicines, as well as medicines for children. In addition, the following four written standards were adopted in the area of quality assurance and are now available for implementation : * Release procedure for International Chemical Reference Substances (update); * WHO guideline on quality risk management (new) * WHO guideline on variations to a prequalified product (update) * Collaborative procedure between the WHO Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products (new).

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188

Published Date

ISBN 10

924120981X

ISBN 13

9789241209816

Book's by WHO Expert Committee on the Selection and Use of Essential Medicines

The Selection and Use of Essential Medicines

The Selection and Use of Essential Medicines

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

The Selection and Use of Essential Medicines

The Selection and Use of Essential Medicines

WHO Expert Committee on Drug Dependence

WHO Expert Committee on Drug Dependence

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade.

Who Expert Committee on Drug Dependence

Who Expert Committee on Drug Dependence

The Selection and Use of Essential Medicines

The Selection and Use of Essential Medicines

WHO Expert Committee on Biological Standardization

WHO Expert Committee on Biological Standardization

Selection and Use of Essential Medicines (The) (RUSSIAN)

Selection and Use of Essential Medicines (The) (RUSSIAN)

The Use of Essential Drugs

The Use of Essential Drugs

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Who Expert Committee on Specifications for Pharmaceutical Preparations

Who Expert Committee on Specifications for Pharmaceutical Preparations

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