Author: C. Lumley
Publisher: Springer Science & Business Media
ISBN: 9400917880
Category : Medical
Languages : en
Pages : 182
Get Book Here
Book Description
Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.
Author: N. McAuslane
Publisher: Springer Science & Business Media
ISBN: 9401148740
Category : Medical
Languages : en
Pages : 174
Get Book Here
Book Description
At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance. The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.
Author: Jerry Brito
Publisher: Mercatus Center at George Mason University
ISBN: 0983607737
Category : Law
Languages : en
Pages : 128
Get Book Here
Book Description
Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107
Get Book Here
Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309065941
Category : Medical
Languages : en
Pages : 89
Get Book Here
Book Description
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309222176
Category : Medical
Languages : en
Pages : 118
Get Book Here
Book Description
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.
Author: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 0812209249
Category : Political Science
Languages : en
Pages : 299
Get Book Here
Book Description
As millions of Americans struggle to find work in the wake of the Great Recession, politicians from both parties look to regulation in search of an economic cure. Some claim that burdensome regulations undermine private sector competitiveness and job growth, while others argue that tough new regulations actually create jobs at the same time that they provide other benefits. Does Regulation Kill Jobs? reveals the complex reality of regulation that supports neither partisan view. Leading legal scholars, economists, political scientists, and policy analysts show that individual regulations can at times induce employment shifts across firms, sectors, and regions—but regulation overall is neither a prime job killer nor a key job creator. The challenge for policymakers is to look carefully at individual regulatory proposals to discern any job shifting they may cause and then to make regulatory decisions sensitive to anticipated employment effects. Drawing on their analyses, contributors recommend methods for obtaining better estimates of job impacts when evaluating regulatory costs and benefits. They also assess possible ways of reforming regulatory institutions and processes to take better account of employment effects in policy decision-making. Does Regulation Kills Jobs? tackles what has become a heated partisan issue with exactly the kind of careful analysis policymakers need in order to make better policy decisions, providing insights that will benefit both politicians and citizens who seek economic growth as well as the protection of public health and safety, financial security, environmental sustainability, and other civic goals. Contributors: Matthew D. Adler, Joseph E. Aldy, Christopher Carrigan, Cary Coglianese, E. Donald Elliott, Rolf Färe, Ann Ferris, Adam M. Finkel, Wayne B. Gray, Shawna Grosskopf, Michael A. Livermore, Brian F. Mannix, Jonathan S. Masur, Al McGartland, Richard Morgenstern, Carl A. Pasurka, Jr., William A. Pizer, Eric A. Posner, Lisa A. Robinson, Jason A. Schwartz, Ronald J. Shadbegian, Stuart Shapiro.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334
Get Book Here
Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Liquefied natural gas
Languages : en
Pages : 88
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309184134
Category : Medical
Languages : en
Pages : 158
Get Book Here
Book Description
The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
