Improving The Regulatory Review Process
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Improving The Regulatory Review Process
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Author : C. Lumley
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Improving The Regulatory Review Process written by C. Lumley and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
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.
Improving The Regulatory Review Process Assessing Performance And Setting Targets
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Author : N. McAuslane
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Improving The Regulatory Review Process Assessing Performance And Setting Targets written by N. McAuslane and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
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.
Improving Regulatory Systems
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Author : National Performance Review (U.S.)
language : en
Publisher:
Release Date : 1994
Improving Regulatory Systems written by National Performance Review (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Administrative procedure categories.
Improving And Accelerating Therapeutic Development For Nervous System Disorders
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2014-02-06
Improving And Accelerating Therapeutic Development For Nervous System Disorders written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-02-06 with Medical categories.
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.
Need To Improve Regulatory Review Process For Liquefied Natural Gas Imports
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Author : United States Accounting Office (GAO)
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2018-06-25
Need To Improve Regulatory Review Process For Liquefied Natural Gas Imports written by United States Accounting Office (GAO) and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-25 with categories.
Need To Improve Regulatory Review Process for Liquefied Natural Gas Imports
Need To Improve Regulatory Review Process For Liquefied Natural Gas Imports
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Author : United States. General Accounting Office
language : en
Publisher:
Release Date : 1978
Need To Improve Regulatory Review Process For Liquefied Natural Gas Imports written by United States. General Accounting Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1978 with Liquefied natural gas categories.
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1999-07-27
Assuring Data Quality And Validity In Clinical Trials For Regulatory Decision Making written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-07-27 with Medical categories.
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.
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-04-04
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-04 with Medical categories.
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.
Preparing For Future Products Of Biotechnology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-07-28
Preparing For Future Products Of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-28 with Science categories.
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Improving Regulatory Systems
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Author : National Performance Review (U.S.)
language : en
Publisher:
Release Date : 1994
Improving Regulatory Systems written by National Performance Review (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Administrative agencies categories.