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Models in Environmental Regulatory Decision Making
Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.
Public Participation in Environmental Assessment and Decision Making
Federal agencies have taken steps to include the public in a wide range of environmental decisions. Although some form of public participation is often required by law, agencies usually have broad discretion about the extent of that involvement. Approaches vary widely, from holding public information-gathering meetings to forming advisory groups to actively including citizens in making and implementing decisions. Proponents of public participation argue that those who must live with the outcome of an environmental decision should have some influence on it. Critics maintain that public participation slows decision making and can lower its quality by including people unfamiliar with the scienc...
Ethical and Scientific Issues in Studying the Safety of Approved Drugs
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively sm...
A new approach to financial regulation
This document outlines the Government's programme of reform to renew the UK's system of financial regulation. It believes that weaknesses were inherent in the tripartite approach whereby three authorities - the Bank of England, the Financial Services Authority and the Treasury - were collectively responsible for financial stability. The Government will create a new Financial Policy Committee (FPC) in the Bank of England with primary statutory duty to maintain financial stability. The FPC will be given control of macro-prudential tools to ensure that systemic risks to financial stability are dealt with. This macro-prudential regulation must be co-ordinated with the prudential regulation of in...
Real-World Evidence in Drug Development and Evaluation
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the p...
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices
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 resou...
The Green Book
This new edition incorporates revised guidance from H.M Treasury which is designed to promote efficient policy development and resource allocation across government through the use of a thorough, long-term and analytically robust approach to the appraisal and evaluation of public service projects before significant funds are committed. It is the first edition to have been aided by a consultation process in order to ensure the guidance is clearer and more closely tailored to suit the needs of users.
OECD Reviews of Regulatory Reform Risk and Regulatory Policy Improving the Governance of Risk
This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.
