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 Operational guidance for evaluating and publicly designating regulatory authorities 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 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book WHO Pharmaceuticals Newsletter written by World Health Organization and published by World Health Organization. This book was released on 2022-09-30 with total page 21 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 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 published by World Health Organization. This book was released on 2023-12-11 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Download or read book Federal Contract Compliance Manual written by United States. Office of Federal Contract Compliance Programs and published by . This book was released on 1990 with total page 1110 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Administrative Careers with America ACWA written by Arco and published by Arco. This book was released on 2002-11-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Administrative Careers With America (ACWA) exam is the test required for thousands of entry-level administrative, professional, and technical positions with the federal government. This guide offers the only preparation available, providing everything test-takers need to launch rewarding government careers.
Download or read book Handbook for Evaluating Infrastructure Regulatory Systems written by Ashley C. Brown and published by World Bank Publications. This book was released on 2006-01-01 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."
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 United States Attorneys Manual written by United States. Department of Justice and published by . This book was released on 1985 with total page 720 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Conditions of Participation for Home Health Agencies written by United States. Social Security Administration and published by . This book was released on 1966 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Marine Corps Manual for Legal Administration LEGADMINMAN written by United States. Marine Corps and published by . This book was released on 1992 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Guide to Personnel Recordkeeping written by and published by . This book was released on 1994 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ten Steps to a Results based Monitoring and Evaluation System written by Jody Zall Kusek and published by World Bank Publications. This book was released on 2004-06-15 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: An effective state is essential to achieving socio-economic and sustainable development. With the advent of globalization, there are growing pressures on governments and organizations around the world to be more responsive to the demands of internal and external stakeholders for good governance, accountability and transparency, greater development effectiveness, and delivery of tangible results. Governments, parliaments, citizens, the private sector, NGOs, civil society, international organizations and donors are among the stakeholders interested in better performance. As demands for greater accountability and real results have increased, there is an attendant need for enhanced results-based monitoring and evaluation of policies, programs, and projects. This Handbook provides a comprehensive ten-step model that will help guide development practitioners through the process of designing and building a results-based monitoring and evaluation system. These steps begin with a OC Readiness AssessmentOCO and take the practitioner through the design, management, and importantly, the sustainability of such systems. The Handbook describes each step in detail, the tasks needed to complete each one, and the tools available to help along the way."
Download or read book Government Auditing Standards written by Government Accounting Office and published by www.Militarybookshop.CompanyUK. This book was released on 2012 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Newly revised in 2011. Contains the auditing standards promulgated by the Comptroller General of the United States. Known as the Yellow Book. Includes the professional standards and guidance, commonly referred to as generally accepted government auditing standards (GAGAS), which provide a framework for conducting high quality government audits and attestation engagements with competence, integrity, objectivity, and independence. These standards are for use by auditors of government entities and entities that receive government awards and audit organizations performing GAGAS audits and attestation engagements.
Download or read book United States Code written by United States and published by . This book was released on 2012 with total page 1216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
