Managing The Regulatory Process
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Managing the Regulatory Process
Author: J. Luis Guasch
language: en
Publisher: World Bank Publications
Release Date: 1999-01-01
'...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
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.
The Pharmaceutical Regulatory Process
Author: Ira R. Berry
language: en
Publisher: Drugs and the Pharmaceutical Sciences
Release Date: 2019-06-07
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