Insights In Regulatory Science 2021
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Insights In Regulatory Science 2021
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Author : Bruno Sepodes
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-04
Insights In Regulatory Science 2021 written by Bruno Sepodes and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-04 with Medical categories.
Regulatory Affairs In The Pharmaceutical Industry
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Author : Javed Ali
language : en
Publisher: Academic Press
Release Date : 2021-11-14
Regulatory Affairs In The Pharmaceutical Industry written by Javed Ali and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-14 with Medical categories.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Oecd Regulatory Policy Outlook 2021
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2021-10-06
Oecd Regulatory Policy Outlook 2021 written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-06 with categories.
The COVID-19 pandemic has highlighted the crucial role regulation plays in the economy and society, but has also exposed gaps in domestic and international rule-making that have cost lives and money. The 2021 Regulatory Policy Outlook, the third in the series, maps country efforts to improve regulatory quality in line with the 2012 OECD Recommendation on Regulatory Policy and Governance, and shares good regulatory practices that can help close the gaps.
Potency Assays For Advanced Stem Cell Therapy Medicinal Products
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Author : Jorge S. Burns
language : en
Publisher: Springer Nature
Release Date : 2023-05-31
Potency Assays For Advanced Stem Cell Therapy Medicinal Products written by Jorge S. Burns and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-31 with Science categories.
This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. —Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology
Women In Science Regulatory Science 2021
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Author : Mette Due Theilade Thomsen
language : en
Publisher: Frontiers Media SA
Release Date : 2023-04-12
Women In Science Regulatory Science 2021 written by Mette Due Theilade Thomsen and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-12 with Medical categories.
Navigating Law And Policy In Stm Enterprises Ethical Governance Regulation And Innovation Strategy
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Author : Zangana, Hewa Majeed
language : en
Publisher: IGI Global
Release Date : 2025-06-13
Navigating Law And Policy In Stm Enterprises Ethical Governance Regulation And Innovation Strategy written by Zangana, Hewa Majeed and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-13 with Business & Economics categories.
To understand the world of Science, Technology, and Medicine (STM) enterprises, it is essential to navigate the complex landscape of law and policy. STM sectors often outpace existing legal frameworks and policies raising unique challenges related to intellectual property, data privacy, and ethical considerations. As STM enterprises develop groundbreaking products and services, understanding and adapting to evolving legal and policy environments becomes essential for sustainable growth, risk management, and public trust. This intersection of law, policy, and technological advancement demands strategic foresight and informed decision-making to ensure responsible and lawful innovation. Navigating Law and Policy in STM Enterprises: Ethical Governance, Regulation, and Innovation Strategy explores the legal and policy landscape that surrounds STM firms and the legal challenges they face. It shows a strategic roadmap of reducing litigation risk while preserving competitive agility. Covering topics such as law, policies, and STM, this book is an excellent resource for STM executives, in-house counsel, compliance officers, policy analysts, researchers, academicians, and more.
Case Studies In Innovative Clinical Trials
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Author : Kristine Broglio
language : en
Publisher: CRC Press
Release Date : 2023-11-27
Case Studies In Innovative Clinical Trials written by Kristine Broglio and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-27 with Medical categories.
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own
Insights In Systems Microbiology 2021
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Author : George Tsiamis
language : en
Publisher: Frontiers Media SA
Release Date : 2022-10-06
Insights In Systems Microbiology 2021 written by George Tsiamis and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-06 with Science categories.
Insights In Plant Metabolism And Chemodiversity 2021
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Author : Laigeng Li
language : en
Publisher: Frontiers Media SA
Release Date : 2023-02-03
Insights In Plant Metabolism And Chemodiversity 2021 written by Laigeng Li and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-03 with Science categories.
Insights In Immunological Tolerance And Regulation 2022
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Author : Lucienne Chatenoud
language : en
Publisher: Frontiers Media SA
Release Date : 2023-10-25
Insights In Immunological Tolerance And Regulation 2022 written by Lucienne Chatenoud and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-10-25 with Medical categories.