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Regional Workshop To Operationalize The Global Guidance Framework For The Responsible Use Of The Life Sciences In The Who African Region

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Regional Workshop To Operationalize The Global Guidance Framework For The Responsible Use Of The Life Sciences In The Who African Region

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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-03-28

Regional Workshop To Operationalize The Global Guidance Framework For The Responsible Use Of The Life Sciences In The Who African Region written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-28 with Law categories.

This report summarizes the discussions of a two-day technical workshop on the operationalization of the global guidance framework in the WHO African Region and the discussions of the partners’ meeting, held in Nairobi, Kenya, on 24-25 January 2023. The workshop, which was organized by the WHO Science Division, in collaboration with the WHO Regional Office for Africa and the Africa Centres for Disease Control and Prevention (Africa CDC), was aimed at discussing the framework and other related existing regional initiatives; facilitating the sharing of knowledge and experience of countries on the challenges and needs in mitigating biorisks and governing dual-use research; strengthening collaboration among multiple and multidisciplinary stakeholders within the WHO African Region; identifying the needs for additional toolkits or regional guidance; and recommending concrete actions for the roll-out of a national implementation of the framework.

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Author :
language : en
Publisher: World Health Organization
Release Date :

written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.

Atelier R Gional Destin Rendre Op Rationnel Le Cadre D Orientation Mondial Pour L Usage Responsable Des Sciences De La Vie Dans La R Gion Africaine De L Oms

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Author : World Health Organization
language : fr
Publisher: World Health Organization
Release Date : 2023-06-06

Atelier R Gional Destin Rendre Op Rationnel Le Cadre D Orientation Mondial Pour L Usage Responsable Des Sciences De La Vie Dans La R Gion Africaine De L Oms written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-06-06 with Law categories.

Le présent rapport résume les débats qui se sont tenus à l’occasion d’un atelier technique de deux jours sur l’opérationnalisation du Cadre d’orientation mondial dans la Région Africaine de l’OMS et les discussions qui ont animé la réunion des partenaires organisée à Nairobi (Kenya) les 24 et 25 janvier 2023. L’atelier, organisé par la Division des sciences de l’OMS, en collaboration avec le Bureau régional de l’OMS pour l’Afrique et les Centres africains de prévention et de contrôle des maladies (CDC Afrique), visait à discuter du cadre et d’autres initiatives régionales connexes, à aider les pays à partager leurs connaissances et leur expérience concernant les défis et les besoins en matière d’atténuation des risques biologiques et de gouvernance de la recherche duale, à renforcer la collaboration entre des parties prenantes multiples et multidisciplinaires au sein de la Région africaine de l’OMS, à recenser les éventuels besoins en matière de boîtes à outils ou d’orientations régionales et à recommander des actions concrètes pour le déploiement du cadre à l’échelle des pays.

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Author : Ирина Алешкова
language : ru
Publisher: Litres
Release Date : 2025-06-25

written by Ирина Алешкова and has been published by Litres this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-25 with Study Aids categories.

В монографии комплексно исследуются понятие, содержание, научные точки зрения и правовое регулирование права на биологическую безопасность в Российской Федерации. Рассматриваются эволюция сущности этого права, взаимосвязи с основными правами человека, оценивается состояние права на биологическую безопасность и определяются перспективы его развития. В центре внимания наиболее актуальные проблемы реализации права на биологическую безопасность, а также судебная практика.Для научных сотрудников, преподавателей, аспирантов и магистров.

Bulletin Of The Atomic Scientists

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Author :
language : en
Publisher:
Release Date : 1972-09

Bulletin Of The Atomic Scientists written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1972-09 with categories.

The Bulletin of the Atomic Scientists is the premier public resource on scientific and technological developments that impact global security. Founded by Manhattan Project Scientists, the Bulletin's iconic "Doomsday Clock" stimulates solutions for a safer world.

Bulletin Of The Atomic Scientists

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Author :
language : en
Publisher:
Release Date : 1972-10

Bulletin Of The Atomic Scientists written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1972-10 with categories.

Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices

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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09

Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-09 with Law categories.

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.

Regional Workshop To Operationalize The Global Guidance Framework For The Responsible Use Of The Life Sciences In The Who African Region

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