Advancing the Discipline of Regulatory Science for Medical Product Development PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Advancing the Discipline of Regulatory Science for Medical Product Development PDF full book. Access full book title Advancing the Discipline of Regulatory Science for Medical Product Development by National Academies of Sciences, Engineering, and Medicine. Download full books in PDF and EPUB format.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309438845
Category : Medical
Languages : en
Pages : 105
Get Book Here
Book Description
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309438845
Category : Medical
Languages : en
Pages : 105
Get Book Here
Book Description
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
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: Barry Leonard
Publisher: DIANE Publishing
ISBN: 1437941354
Category : Health & Fitness
Languages : en
Pages : 20
Get Book Here
Book Description
This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.
Author:
Publisher: Oxford University Press
ISBN: 0190848944
Category : Nature
Languages : en
Pages : 593
Get Book Here
Book Description
In the last several decades, there has been a surge of interest in expertise in the social scientific, philosophical, and legal literatures. While it is tempting to attribute this surge of interest in expertise to the emergence and consolidation of a "knowledge society," "post-industrial society," or "network society," it is more likely that the debates about expertise are symptomatic of significant change and upheaval. As the number of contenders for expert status has increased, as the bases for their claims have become more diverse, and as the struggles between these would-be experts intensified, expertise became problematic and contested. In The Oxford Handbook of Expertise and Democratic Politics, Gil Eyal and Thomas Medvetz have brought together a broad group of scholars who have engaged substantively and theoretically with debates regarding the nature of expertise and the social roles of experts to examine these areas within sociology and allied disciplines. The analyses take an historical and relational approach to the topic and are motivated by the sense that growing mistrust in experts represents a danger to democratic politics today. Among the topics considered here are the value and relevance of the boundary between experts and laypeople; the causes and consequences of mistrust in experts; the meanings and social uses of objectivity; and the significance of recent transformations in the organization of the professions. Bringing together investigations from social scientists, philosophers, and legal scholars into the political dimensions of expertise, this Handbook connects interdisciplinary work done in science and technology studies with the more classic concerns, topics, and concepts of sociologists of professions and intellectuals.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309455650
Category : Medical
Languages : en
Pages : 103
Get Book Here
Book Description
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284791
Category : Medical
Languages : en
Pages : 129
Get Book Here
Book Description
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Author: Harold R Collard
Publisher: Elsevier Health Sciences
ISBN: 0323757847
Category : Medical
Languages : en
Pages : 177
Get Book Here
Book Description
In this issue of Clinics in Chest Medicine, Guest Editors Harold R Collard, Luca Richeldi, and Kerri A. Johannson bring their considerable expertise to the topic of Next-generation Interstitial Lung Disease. - Provides concise and comprehensive coverage of the issues physicians face every day. - Presents the latest information on a timely, focused topic under the leadership of experienced editors in the field.
Author: Harry Yang
Publisher: CRC Press
ISBN: 0429676824
Category : Mathematics
Languages : en
Pages : 191
Get Book Here
Book Description
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 pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
Author:
Publisher: Academic Press
ISBN: 0128144556
Category : Medical
Languages : en
Pages : 974
Get Book Here
Book Description
The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241515430
Category : Business & Economics
Languages : en
Pages : 228
Get Book Here
Book Description
This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and finally the country profiles. Apart from the section on practices and practitioners the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners which covers providers education and health insurance is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is before and after the first WHO Traditional Medicine Strategy (1999?2005) from the first global survey to the second global survey (2005?2012) and from the second survey to the most recent timeline (2012?2018).
