Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities
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Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-14
Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities 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 2023-11-14 with Medical categories.
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.
Operational Guidance For Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-14
Operational Guidance For Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities 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 2023-11-14 with Medical categories.
The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provide procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO-listed authority (WLA). The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the technical advisory group on WLAs (TAG-WLA) and the undertakings of WHO and eligible regulatory authorities.
Who Pharmaceuticals Newsletter
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2022-09-30
Who Pharmaceuticals Newsletter 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 2022-09-30 with Medical categories.
Guidance On Development And Implementation Of A National Deployment And Vaccination Plan For Vaccines Against Pandemic Influenza And Other Respiratory Viruses Of Pandemic Potential
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-12-11
Guidance On Development And Implementation Of A National Deployment And Vaccination Plan For Vaccines Against Pandemic Influenza And Other Respiratory Viruses Of Pandemic Potential 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 2023-12-11 with Medical categories.
Vaccines are powerful weapons in the fight against pandemic viruses as shown by responses to both the 2009 H1N1 influenza and the COVID-19 pandemics. However, planning for accessing, allocating and deploying vaccines in a pandemic situation is a complex endeavour, beset with multiple challenges at all levels – local, regional and global. The World Health Organization (WHO) and its partners have prepared this revised guidance document to assist countries update their national deployment and vaccination plans (NDVPs) by leveraging global learnings from past pandemic responses, including the recent COVID-19 vaccination effort. The development and testing of a NDVP would not only advance pandemic preparedness efforts but would also have benefits in terms of increasing national capabilities to manage other health emergencies which require emergency vaccination campaigns.
Who Global Benchmarking Tool Gbt For Evaluation Of National Regulatory System Of Medical Products
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-02-29
Who Global Benchmarking Tool Gbt For Evaluation Of National Regulatory System Of Medical Products 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 2024-02-29 with Medical categories.
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.
Federal Register
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Author :
language : en
Publisher:
Release Date : 2013-07
Federal Register written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07 with Delegated legislation categories.
The Governance Of Regulators Driving Performance At Peru S Telecommunications Regulator
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2019-03-05
The Governance Of Regulators Driving Performance At Peru S Telecommunications Regulator written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-05 with categories.
As “market referees”, regulators contribute to the delivery of essential public utilities. Their organisational culture, behaviour and governance are important factors in how regulators, and the sectors they oversee, perform. This report uses the OECD Performance Assessment Framework for ...
Labor Relations Reference Manual
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Author :
language : en
Publisher:
Release Date : 1986
Labor Relations Reference Manual written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1986 with Arbitration, Industrial 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.
Code Of Federal Regulations
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Author :
language : en
Publisher:
Release Date : 2001
Code Of Federal Regulations written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Administrative law categories.
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.