Building A National Framework For The Establishment Of Regulatory Science For Drug Development
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Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 94 pages File Size : 43,8 Mb Release : 2011-02-15 Category : Medical ISBN : 9780309209595
Building a National Framework for the Establishment of Regulatory Science for Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 118 pages File Size : 49,8 Mb Release : 2012-04-04 Category : Medical ISBN : 9780309222174
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
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.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 94 pages File Size : 42,7 Mb Release : 2011-03-15 Category : Medical ISBN : 9780309158893
Building a National Framework for the Establishment of Regulatory Science for Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Publisher : National Academies Press Page : 442 pages File Size : 55,8 Mb Release : 2011-04-03 Category : Medical ISBN : 9780309158060
Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Publisher : National Academies Press Page : 169 pages File Size : 52,6 Mb Release : 2020-04-25 Category : Medical ISBN : 9780309498630
Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Institute of Medicine,Committee on Technological Innovation in Medicine
Author : Institute of Medicine,Committee on Technological Innovation in Medicine Publisher : National Academies Press Page : 241 pages File Size : 46,6 Mb Release : 1990-02-01 Category : Medical ISBN : 9780309042864
Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 107 pages File Size : 50,7 Mb Release : 2014-02-06 Category : Medical ISBN : 9780309292498
Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Publisher : National Academies Press Page : 145 pages File Size : 42,6 Mb Release : 2018-02-12 Category : Medical ISBN : 9780309457972
The Drug Development Paradigm in Oncology by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 129 pages File Size : 48,6 Mb Release : 2013-11-24 Category : Medical ISBN : 9780309284790
International Regulatory Harmonization Amid Globalization of Drug Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 105 pages File Size : 41,8 Mb Release : 2016-07-11 Category : Medical ISBN : 9780309438872
Advancing the Discipline of Regulatory Science for Medical Product Development by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
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.
Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Publisher : National Academies Press Page : 141 pages File Size : 41,9 Mb Release : 2010-10-04 Category : Medical ISBN : 9780309162906
Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System Publisher : National Academies Press Page : 231 pages File Size : 47,8 Mb Release : 2017-07-28 Category : Science ISBN : 9780309452052
Preparing for Future Products of Biotechnology by National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System Pdf
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.
Pedagogies for Pharmacy Curricula by Figueiredo, Isabel Vitória,Cavaco, Afonso Miguel Pdf
While the pharmaceutical industry evolves, the need for curriculum changes inherently follows suit. As healthcare systems have continuously improved through the use of big data and innovative care approaches, practicing pharmacists have also had to adjust and expand their roles. As such, it is imperative that the current and future pharmaceutical workforce is properly trained, taking into account new competencies that are needed to provide exceptional multidisciplinary patient healthcare. Pedagogies for Pharmacy Curricula presents emerging teaching practices and methods for pharmacy curricula and reviews pedagogic methodologies on the scope of pharmaceutical care in pharmacy curricula. The chapters present learning outcomes on general and specific topics, impact of undergraduate interventions on patient outcomes, and comparisons between different teaching pedagogies/models. While highlighting topic areas such as perspectives on learning and teaching, evidence-based practice education, and the relationships between academia and professionals, this book is ideal for health professionals, pharmacists, teachers, schools of pharmacy, medical school faculty, international organizations, clinicians, practitioners, researchers, academicians, and students who are interested in learning about the latest pedagogic methodologies in pharmacy curricula.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 248 pages File Size : 41,6 Mb Release : 2012-09-13 Category : Medical ISBN : 9780309253185
Envisioning a Transformed Clinical Trials Enterprise in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure by Marcia Crosse Pdf
Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Dept. of Health and Human Services (HHS) and the Dept. of Defense (DOD) support the development of technologies that can be used in producing technologies that can be used in producing influenza vaccines. HHS’s Food and Drug Admin. (FDA) reviews licensing applications for new vaccine, and the Dept. of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. This report examines (1) federal funding from FY 2005 through March 2011 for alternative technologies and the status of manufacturers’ efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. Tables and figures. This is a print on demand report.
