Regulatory Innovation

Regulatory Innovation
Author: Julia Black
Publisher: Edward Elgar Publishing
Total Pages: 240
Release: 2006-01-01
Genre: Law
ISBN: 1845427971

The book is a good read due to its well-integrated form, its comparative approach, its empirical case descriptions and its ability to encourage readers to approach the field of regulatory innovation. Estrid Sørensen, Science Studies Much hype has been generated about the importance of innovation for public and private sector organisations. Regulatory Innovation offers the first detailed study of regulatory innovation in a multiplicity of countries and domains. This book draws on in-depth studies of innovation in regulatory instruments and practices across high- and low-technology sectors, across different countries and from the early to the late 20th century. Highlighting different worlds of regulatory innovation those of the individual, the organization, the state, the global polity, and innovation itself, this book offers a fresh perspective and valuable insights for the practice and study of regulatory innovation. The explicit comparative focus of the case studies and the worlds of regulatory innovation approach make this book essential reading for academic researchers and students interested in regulation.

Innovation and the State

Innovation and the State
Author: Cristie Ford
Publisher: Cambridge University Press
Total Pages: 374
Release: 2017-12-07
Genre: Law
ISBN: 1108514669

From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

Digital Innovation in Financial Services

Digital Innovation in Financial Services
Author: Phoebus Athanassiou
Publisher: International Banking and Fina
Total Pages: 288
Release: 2018-02-08
Genre: Computers
ISBN: 9789041187819

Digital Innovation in Financial Services' is a comprehensive legal assessment of FinTech or digital financial innovation covering its potential applications to payments, securities clearing and settlement, crowd-funding, and central banking. It is the first systematic attempt at proposing a conceptual framework against which to consider the most advisable regulatory policy approach vis-à-vis this incipient phenomenon. Consumer behaviour is rapidly trending towards the use of digital devices as instruments through which to transact day-to-day business. This book shows how the global digitisation trend and the steadily rising consumer demand for innovation in the field of financial services create new opportunities not only for retail consumers but also for financial service providers, regulators, and central banks. The author offers a comprehensive overview of these opportunities and their countervailing legal and regulatory challenges.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 118
Release: 2012-04-04
Genre: Medical
ISBN: 0309222176

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Innovation and Protection

Innovation and Protection
Author: I. Glenn Cohen
Publisher: Cambridge University Press
Total Pages: 295
Release: 2022-04-07
Genre: Law
ISBN: 1108838634

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 225
Release: 1991-02-01
Genre: Medical
ISBN: 030904491X

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Environmental Contracts:Comparative Approaches to Regulatory Innovation in the United States and Europe

Environmental Contracts:Comparative Approaches to Regulatory Innovation in the United States and Europe
Author: Eric W. Orts
Publisher: Kluwer Law International B.V.
Total Pages: 466
Release: 2001-03-20
Genre: Law
ISBN: 9041198210

Environmental regulation has come of age in recent decades as the blunt methods of command-and-control have been subjected to trenchant criticism from both economists and lawyers in the United States and Europe. As a result of this intellectual development, as well as continuing and increasing severity of environmental problems, there is a need for fresh thinking about regulatory methods that are rational from both economic and legal points of view. This book focuses on the viability of one particular regulatory innovation--the use of agreements or contracts for environmental regulation--as it has been practised in the United States and Europe. The various contributions explore the general idea that certain kinds of environmental problems may best be addressed through contracts among interested parties, including representatives of various levels of government, business, local community and employment representatives, and public interest groups. The parties get together to discuss a particular problem and then agree to an agreement or contract designed to address key issues and interests. At least in some situations, this approach may yield greater flexibility, stronger commitment, and more creative outcomes than traditional command-and-control regulation. Experiments in the use of environmental contracts have begun on both sides of the Atlantic, a fact which makes the comparative study offered here especially timely and valuable.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 141
Release: 2010-10-04
Genre: Medical
ISBN: 0309162904

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

The Intellectual Property–Regulatory Complex

The Intellectual Property–Regulatory Complex
Author: Emily Marden
Publisher: UBC Press
Total Pages: 273
Release: 2016-03-06
Genre: Law
ISBN: 0774831812

Advances in agricultural genomics could help address pressing global issues, such as world hunger, by improving crop yield. However, overlap and conflict in intellectual property and biosafety regimes – known collectively as the “Intellectual Property–Regulatory Complex” – create significant barriers to innovation. In this collection, leading legal, policy, and economics experts analyze the impact of the Complex on agricultural genomics. They reveal how it impacts scientific advancement in ways that are underappreciated when intellectual property and biosafety regimes are examined in isolation. After identifying how the interplay between multiple regimes impedes research, development, and product distribution, they propose solutions that would further the aims of the current intellectual property and biosafety regimes while enabling growth and innovation in agricultural genomics.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 442
Release: 2011-04-03
Genre: Medical
ISBN: 0309158060

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.