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Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-05-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030943887X Total Pages :105 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing the Discipline of Regulatory Science for Medical Product Development by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing the Discipline of Regulatory Science for Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-07-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 :0309438845 Total Pages :105 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing the Discipline of Regulatory Science for Medical Product Development by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing the Discipline of Regulatory Science for Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-08-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis International Regulatory Harmonization Amid Globalization of Drug Development by : Institute of Medicine
Download or read book International Regulatory Harmonization Amid Globalization of Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2013-11-24 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pedagogies for Pharmacy Curricula by : Figueiredo, Isabel Vitória
Download or read book Pedagogies for Pharmacy Curricula written by Figueiredo, Isabel Vitória and published by IGI Global. This book was released on 2021-02-19 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309670438 Total Pages :243 pages Book Rating :4.3/5 (96 download)
Book Synopsis Stronger Food and Drug Regulatory Systems Abroad by : National Academies of Sciences, Engineering, and Medicine
Download or read book Stronger Food and Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-09 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.
Book Synopsis International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by : Pierre-Louis Lezotre
Download or read book International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area
Book Synopsis Building a National Framework for the Establishment of Regulatory Science for Drug Development by : Institute of Medicine
Download or read book Building a National Framework for the Establishment of Regulatory Science for Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2011-02-15 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine
Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309379512 Total Pages :283 pages Book Rating :4.3/5 (93 download)
Book Synopsis Optimizing the Nation's Investment in Academic Research by : National Academies of Sciences, Engineering, and Medicine
Download or read book Optimizing the Nation's Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Disaster Resilience by : National Academies
Download or read book Disaster Resilience written by National Academies and published by National Academies Press. This book was released on 2012-12-29 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: No person or place is immune from disasters or disaster-related losses. Infectious disease outbreaks, acts of terrorism, social unrest, or financial disasters in addition to natural hazards can all lead to large-scale consequences for the nation and its communities. Communities and the nation thus face difficult fiscal, social, cultural, and environmental choices about the best ways to ensure basic security and quality of life against hazards, deliberate attacks, and disasters. Beyond the unquantifiable costs of injury and loss of life from disasters, statistics for 2011 alone indicate economic damages from natural disasters in the United States exceeded $55 billion, with 14 events costing more than a billion dollars in damages each. One way to reduce the impacts of disasters on the nation and its communities is to invest in enhancing resilience-the ability to prepare and plan for, absorb, recover from and more successfully adapt to adverse events. Disaster Resilience: A National Imperative addresses the broad issue of increasing the nation's resilience to disasters. This book defines "national resilience", describes the state of knowledge about resilience to hazards and disasters, and frames the main issues related to increasing resilience in the United States. It also provide goals, baseline conditions, or performance metrics for national resilience and outlines additional information, data, gaps, and/or obstacles that need to be addressed to increase the nation's resilience to disasters. Additionally, the book's authoring committee makes recommendations about the necessary approaches to elevate national resilience to disasters in the United States. Enhanced resilience allows better anticipation of disasters and better planning to reduce disaster losses-rather than waiting for an event to occur and paying for it afterward. Disaster Resilience confronts the topic of how to increase the nation's resilience to disasters through a vision of the characteristics of a resilient nation in the year 2030. Increasing disaster resilience is an imperative that requires the collective will of the nation and its communities. Although disasters will continue to occur, actions that move the nation from reactive approaches to disasters to a proactive stance where communities actively engage in enhancing resilience will reduce many of the broad societal and economic burdens that disasters can cause.
Book Synopsis Strengthening Forensic Science in the United States by : National Research Council
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309457971 Total Pages :145 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Drug Development Paradigm in Oncology by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Drug Development Paradigm in Oncology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-02-12 with total page 145 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Accelerating the Development of New Drugs and Diagnostics by : Institute of Medicine
Download or read book Accelerating the Development of New Drugs and Diagnostics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-23 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cures Acceleration Network (CAN)-a part of the National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH)-has the potential to catalyze widespread changes in NCATS, NIH, and the drug development ecosystem in general. On June 4-5, 2012, the IOM Forum on Drug Discovery, Development, and Translation held, at the request of NCATS, a workshop-bringing together members of federal government agencies, the private sector, academia, and advocacy groups-to explore options and opportunities in the implementation of CAN. Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary summarizes the workshop.
Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine
Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
