Managing The Regulatory Process
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Managing The Regulatory Process
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Author : J. Luis Guasch
language : en
Publisher: World Bank Publications
Release Date : 1999-01-01
Managing The Regulatory Process written by J. Luis Guasch and has been published by World Bank Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-01-01 with Political Science categories.
'...developing countries, complementing their far-reaching privatization programs, are engaged in deregulating various sectors of their economies and devising new regulatory frameworks for others, particularly the utilities sectors.' As economies become more open, pressures on countries to become more competitive drive the call for regulatory reform to reduce costs and foster increased productivity, competitiveness, and growth. This report provides an overview of the costs and benefits of regulation throughout the world. It provides case histories of regulation in different countries, developed and developing and in various sectors, such as, transportation, utilities, and power. It presents different strategies that were employed. Furthermore, it identifies lessons learned and lays the foundations for a best practice scenario for other countries to adopt. While the challenges to regulatory reform are considerable, so are the efforts that developing countries are making to face them. These lessons, when properly adapted to each country's own environment, can significantly increase the likelihood of effective regulation.
Handbook On Business Process Management 2
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Author : Jan vom Brocke
language : en
Publisher: Springer
Release Date : 2014-08-28
Handbook On Business Process Management 2 written by Jan vom Brocke and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-28 with Business & Economics categories.
Business Process Management (BPM) has become one of the most widely used approaches for the design of modern organizational and information systems. The conscious treatment of business processes as significant corporate assets has facilitated substantial improvements in organizational performance but is also used to ensure the conformance of corporate activities. This Handbook presents in two volumes the contemporary body of knowledge as articulated by the world's leading BPM thought leaders. This second volume focuses on the managerial and organizational challenges of BPM such as strategic and cultural alignment, governance and the education of BPM stakeholders. As such, this book provides concepts and methodologies for the integration of BPM. Each chapter has been contributed by leading international experts. Selected case studies complement their views and lead to a summary of BPM expertise that is unique in its coverage of the most critical success factors of BPM. The second edition of this handbook has been significantly revised and extended. Each chapter has been updated to reflect the most current developments. This includes in particular new technologies such as in-memory data and process management, social media and networks. A further focus of this revised and extended edition is on the actual deployment of the proposed theoretical concepts. This volume includes a number of entire new chapters from some of the world's leading experts in the domain of BPM.
Handbook Of Self Regulatory Processes In Development
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Author : Karen Caplovitz Barrett
language : en
Publisher: Psychology Press
Release Date : 2013
Handbook Of Self Regulatory Processes In Development written by Karen Caplovitz Barrett and has been published by Psychology Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Education categories.
Section 1. Development of emotion regulation and self-regulation / section editor: Karen Caplovitz Barrett -- section 2. Development of self-regulation : physiological and brain processes / section editor: Nathan A. Fox -- section 3. Development of self-regulation and mastery motivation / section editor: George A. Morgan -- section 4. Self-regulation in atypical development / section editors: Deborah J. Fidler and Lisa A. Daunhauer.
The Pharmaceutical Regulatory Process
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Author : Ira R. Berry
language : en
Publisher: Drugs and the Pharmaceutical Sciences
Release Date : 2019-06-07
The Pharmaceutical Regulatory Process written by Ira R. Berry and has been published by Drugs and the Pharmaceutical Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-07 with Drugs categories.
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards
Maintenance Management And Regulatory Compliance Strategies
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Author : Terry Wireman
language : en
Publisher: Industrial Press Inc.
Release Date : 2003
Maintenance Management And Regulatory Compliance Strategies written by Terry Wireman and has been published by Industrial Press Inc. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Business & Economics categories.
Regulatory agencies and their requirements.
The Regulatory Craft
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Author : Malcolm K. Sparrow
language : en
Publisher: Rowman & Littlefield
Release Date : 2011-01-01
The Regulatory Craft written by Malcolm K. Sparrow and has been published by Rowman & Littlefield this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-01 with Law categories.
The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.
Regulatory Affairs In The Pharmaceutical Industry
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Author : Javed Ali
language : en
Publisher: Academic Press
Release Date : 2021-11-14
Regulatory Affairs In The Pharmaceutical Industry written by Javed Ali and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-14 with Medical categories.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Guidelines For The Management Of Change For Process Safety
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Author : CCPS (Center for Chemical Process Safety)
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Guidelines For The Management Of Change For Process Safety written by CCPS (Center for Chemical Process Safety) and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Technology & Engineering categories.
Guidelines for the Management of Change for Process Safety provides guidance on the implementation of effective and efficient Management of Change (MOC) procedures, which can be applied to improve process safety. In addition to introducing MOC systems, the book describes how to design an initial system from scratch, including the scope of the system and the applications over a plant life cycle and the boundaries and overlaps with other process safety management systems. Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.
Navigating The Fda Regulatory Processes
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Author : Yitzhak Rosen
language : en
Publisher: CRC Press
Release Date : 2025-01-31
Navigating The Fda Regulatory Processes written by Yitzhak Rosen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-31 with Medical categories.
This book provides a unique knowledge source of the FDA’s regulatory processes to anyone interested in the development and approval of biomedical products. Navigating the FDA Regulatory Processes will be of particular importance for those innovating in biomedical devices, pharmacological therapies, and combination products, who are interested in considering regulatory affairs early on in product development. The authors offer a comprehensive exploration of FDA regulations, providing industry insights and guidance for navigating the complexities of drug and device development. The book offers concrete examples, industry perspectives, and historical context, ensuring clarity and aiding in successful understanding of the requirements for regulatory compliance. Readers will also gain a thorough understanding of FDA regulatory processes, from securing approvals to navigating expedited pathways. Lastly, the book provides unique insights into the FDA approach for emergency preparedness, including discussing the recent COVID-19 pandemic. Biomedical industry personnel, engineers, scientists, entrepreneurs, medical doctors, students, and anyone interested in the development and approval of medical products in the US will find this book useful and essential.
Methods To Assess And Manage Process Safety In Digitalized Process System
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Author : Faisal Khan
language : en
Publisher: Academic Press
Release Date : 2022-07-06
Methods To Assess And Manage Process Safety In Digitalized Process System written by Faisal Khan and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-06 with Technology & Engineering categories.
Methods to Assess and Manage Process Safety in Digitalized Process System, Volume Six, the latest release in the Methods in Chemical Process Safety series, highlights new advances in the field, with this new volume presenting interesting chapters written by an international board of authors. - Provides the authority and expertise of leading contributors from an international board of authors - Presents the latest release in the Methods in Chemical Process Safety series - Provides the authority and expertise of leading contributors from an international board of authors