Download or read book Global competency framework for regulators of medicines written by World Health Organization and published by World Health Organization. This book was released on 2023-11-14 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Global competency framework for regulators of medicines provides a framework for best practices and general considerations aimed at harmonizing workforce development efforts for the regulation of medicines by establishing an internationally accepted set of organizational and role-specific competencies.

Download or read book WHO Global Benchmarking Tool GBT for evaluation of national regulatory system of medical products written by World Health Organization and published by World Health Organization. This book was released on 2024-02-29 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual is intended to provide clear operational guidance on the benchmarking of regulatory systems for medical products and the development of institutional development plans (IDPs) to address areas for improvement. The manual is integral to the World Health Organization’s structured and evidence-based approach to regulatory systems strengthening (RSS), mandated by World Health Assembly resolution WHA 67.20. The manual serves to ensure a proper understanding of the Global Benchmarking Tool (GBT); the processes and principles that govern its use; the expectations of individuals and institutions involved; and the information management systems that underpin the collection, analysis and management of data and the generation of knowledge.

Download or read book Manual for performance evaluation of regulatory authorities seeking designation as WHO listed authorities written by World Health Organization and published by World Health Organization. This book was released on 2023-11-14 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual provides operational and technical details for the performance evaluation (PE) exercise that must be conducted for a regulatory authority (RA) to achieve listing as a WHO-listed authority (WLA) in relation to each regulatory function. The PE manual should be read in conjunction with the Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities (“The Operational Guidance”). For the purposes of this document the term regulatory authority (RA), unless otherwise stated, may refer to either a national regulatory authority (NRA) or a regional regulatory system (RRS). The basis for designation as a WLA is provided by the Global Benchmarking Tool (GBT), which is complemented by a series of PE activities designed to establish a detailed picture of how the regulatory system performs on relevant regulatory processes, including how consistently it adheres to quality procedures and how well it delivers the desired regulatory outputs in accordance with good regulatory practices.

Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2023-05-26 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 76th meeting of the WHO Expert Committee on Biological Standardization was held from 24 to 28 October 2023 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Clive Ondari, Director, Health Products Policy and Standards. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, policymakers, health workers, developers of vaccines and other biological products and academia.

Download or read book Global vaccine safety blueprint 2 0 GVSB2 0 2021 2023 written by and published by World Health Organization. This book was released on 2021-11-17 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2016 USDA Inspector General USDA Food Safety and Inspection Service Commodity Futures Trading Commission Farm Credit Administration written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2015 with total page 1140 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book WHO Expert Committee on Biological Standardization written by and published by World Health Organization. This book was released on 2020-05-15 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 biological substances, 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 and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, WHO Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: antibiotics; biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1).

Download or read book WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices written by World Health Organization and published by . This book was released on 2017-05-09 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.

Download or read book Grand Challenges in Pharmaceutical Medicine Competencies and Ethics in Medicines Development written by Honorio Silva and published by Frontiers Media SA. This book was released on 2021-07-08 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2020-04-21 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Encyclopedia of Pharmacy Practice and Clinical Pharmacy written by and published by Academic Press. This book was released on 2019-06-28 with total page 2370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos

Download or read book Global competency framework for universal health coverage written by and published by World Health Organization. This book was released on 2022-04-04 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Agriculture Rural Development Food and Drug Administration and Related Agencies Appropriations for 2007 Research education and economic programs written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2006 with total page 1732 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Global Competency and Outcomes Framework for Universal Health Coverage written by World Health Organization and published by World Health Organization. This book was released on 2022-03-31 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Encyclopedia of Forensic and Legal Medicine written by and published by Academic Press. This book was released on 2015-09-29 with total page 3080 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Forensic and Legal Medicine, Volumes 1-4, Second Edition is a pioneering four volume encyclopedia compiled by an international team of forensic specialists who explore the relationship between law, medicine, and science in the study of forensics. This important work includes over three hundred state-of-the-art chapters, with articles covering crime-solving techniques such as autopsies, ballistics, fingerprinting, hair and fiber analysis, and the sophisticated procedures associated with terrorism investigations, forensic chemistry, DNA, and immunoassays. Available online, and in four printed volumes, the encyclopedia is an essential reference for any practitioner in a forensic, medical, healthcare, legal, judicial, or investigative field looking for easily accessible and authoritative overviews on a wide range of topics. Chapters have been arranged in alphabetical order, and are written in a clear-and-concise manner, with definitions provided in the case of obscure terms and information supplemented with pictures, tables, and diagrams. Each topic includes cross-referencing to related articles and case studies where further explanation is required, along with references to external sources for further reading. Brings together all appropriate aspects of forensic medicine and legal medicine Contains color figures, sample forms, and other materials that the reader can adapt for their own practice Also available in an on-line version which provides numerous additional reference and research tools, additional multimedia, and powerful search functions Each topic includes cross-referencing to related articles and case studies where further explanation is required, along with references to external sources for further reading

Download or read book How to Develop and Implement a National Drug Policy written by World Health Organization and published by World Health Organization. This book was released on 2001 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: A drug policy is a crucial ingredient in every country's national health strategy as it provides a strategic framework to identify goals and commitments. This publication discusses the key components of such a policy. Issues covered include: the selection of essential drugs, affordability; finance and supply; regulation and quality assurance; rational use; research; human resources; monitoring and evaluation.