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Bringing Advanced Therapy Medicinal Products Atmps To The Clinic And Beyond How To Ensure The Sustainable And Affordable Introduction Of Atmps Into Healthcare
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Book Synopsis Bringing Advanced Therapy Medicinal Products (ATMPs) to the Clinic and Beyond: How to Ensure the Sustainable and Affordable Introduction of ATMPs Into Healthcare by : Hans-Dieter Volk
Download or read book Bringing Advanced Therapy Medicinal Products (ATMPs) to the Clinic and Beyond: How to Ensure the Sustainable and Affordable Introduction of ATMPs Into Healthcare written by Hans-Dieter Volk and published by Frontiers Media SA. This book was released on 2022-11-30 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer Nature. This book was released on 2023-08-01 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent ‘must-know’ guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Author :The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada Publisher :Council of Canadian Academies ISBN 13 :1926522796 Total Pages :122 pages Book Rating :4.9/5 (265 download)
Book Synopsis From Research to Reality by : The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada
Download or read book From Research to Reality written by The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada and published by Council of Canadian Academies. This book was released on 2020-11-05 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: From Research to Reality describes the stages involved in the approval and use of gene therapies in Canada, and examines challenges associated with regulatory oversight, manufacturing, access, and affordability, and identifies promising approaches to address them.
Book Synopsis Practical Approaches to Risk Minimisation for Medicinal Products by : World Health Organization
Download or read book Practical Approaches to Risk Minimisation for Medicinal Products written by World Health Organization and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
Book Synopsis Personalised Health Care by : Stefania Boccia
Download or read book Personalised Health Care written by Stefania Boccia and published by Springer Nature. This book was released on 2020-11-23 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practitioners are increasingly adopting a personalised medicine approach to individually tailored patient care, especially disease diagnosis and treatment with the use of biomarkers. However, development and implementation of such approaches to chronic disease prevention need further investigation and concerted efforts for proper use in healthcare systems. This book provides high-quality, multidisciplinary knowledge from research in personalised medicine, specifically personalised prevention of chronic disease. It addresses different perspectives of prevention in the field, and is the outcome of a four-year work of the Personalized prevention of Chronic Disease (PRECeDI) Consortium, a multi-disciplinary and multi-professional team of experts. The Consortium jointly agreed to document and address the five aspects or domains of personalised medicine and prevention as individual chapters: Identification of biomarkers for the prevention of chronic disease Evaluation of predictive genomic applications Ethico-legal and policy issues surrounding personalised medicine Roles and responsibilities of stakeholders in informing healthy individuals on their genome: a sociotechnical analysis Identification of organisational models for the provision of predictive genomic applications The book focuses on the Consortium's recommendations that are derived from each of these domains based on up-to-date evidence and research that the authors write, follow, and systematically organise and report. Personalisation of health care is, eventually, a driver of innovation in research and healthcare systems. With this SpringerBrief on Personalised Health Care: Fostering Precision Medicine Advancements for Gaining Population Health Impact, the Consortium provides further evidence of the clinical validity and utility of personalised medicine with special emphasis on the prevention of chronic diseases. The book is a useful resource for policy makers, industry and healthcare professionals, scientists, technology-sector professionals, investors, citizens, and private companies that need proper advice to realise the potential of personalised medicine.
Download or read book European Regulatory Agencies written by and published by . This book was released on 2004 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Pharmacology: Current Topics and Case Studies by : Markus Müller
Download or read book Clinical Pharmacology: Current Topics and Case Studies written by Markus Müller and published by Springer Science & Business Media. This book was released on 2011-02-04 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.
Book Synopsis The EBMT Handbook by : Nicolaus Kröger
Download or read book The EBMT Handbook written by Nicolaus Kröger and published by . This book was released on 2020-10-08 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open Access edition of the European Society for Blood and Marrow Transplantation (EBMT) handbook addresses the latest developments and innovations in hematopoietic stem cell transplantation and cellular therapy. Consisting of 93 chapters, it has been written by 175 leading experts in the field. Discussing all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, it also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies. This book provides an unparalleled description of current practices to enhance readers' knowledge and practice skills. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Book Synopsis Hospitals and Borders by : Centers of Disease Control
Download or read book Hospitals and Borders written by Centers of Disease Control and published by World Health Organization. This book was released on 2013 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume examines why hospitals collaborate with each other and with other health care actors across borders in Europe. Cross-border hospital collaboration is not a new phenomenon but began to receive increased attention in the first decade of the 21st century in the context of European debates on patient mobility, the impact of European Union (EU) integration on national health systems and the particular situation of border regions. In this context, the role of health care providers stands out: while physically anchored in the health system that funds and regulates them, hospitals in border regions often witness or initiate cross-border movements of patients and health professionals.
Author :European Directorate for the Quality of Medicines & Healthcare Publisher : ISBN 13 :9789287176394 Total Pages :320 pages Book Rating :4.1/5 (763 download)
Book Synopsis Guide to the Quality and Safety of Tissues and Cells for Human Application by : European Directorate for the Quality of Medicines & Healthcare
Download or read book Guide to the Quality and Safety of Tissues and Cells for Human Application written by European Directorate for the Quality of Medicines & Healthcare and published by . This book was released on 2013-10-11 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types
Book Synopsis Guidelines for the blood transfusion services in the United Kingdom by : United Kingdom Blood Transfusion Services
Download or read book Guidelines for the blood transfusion services in the United Kingdom written by United Kingdom Blood Transfusion Services and published by Stationery Office. This book was released on 2005-10-12 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the seventh edition of a book that provides best practice guidelines and detailed technical procedures for blood transfusion services. It takes account of the European Directives on blood and tissues and resulting UK regulations and indicates which of the guidelines that are now legal requirements.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Book Synopsis GDPR and Biobanking by : Jane Reichel
Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Book Synopsis Establishing a Hematopoietic Stem Cell Transplantation Unit by : Éliane Gluckman
Download or read book Establishing a Hematopoietic Stem Cell Transplantation Unit written by Éliane Gluckman and published by Springer. This book was released on 2017-11-17 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text aims to provide simplified practical guidelines to start a hematopoietic stem cell transplantation unit which could be implemented in most centers and countries worldwide. The book also provides guidelines for existing transplantation units to upgrade their practice and implement new policies and procedures, in addition to developing therapies according to latest international standards and regulations. The book covers a wide range of practical implementation tools including HSCT program team structure, building inpatient and outpatient HSCT units, requisite laboratory support for transplantation program, practical aspects of stem cell collection and processing, HSCT program quality management, education and training, and data management. The book also addresses cost effectiveness and recommendations for establishing transplantation program in countries with limited resources. Written by group of internationally established experts in their corresponding hematopoietic stem cell transplantation fields, with contributions from many leaders of hematopoietic stem cell transplantation organizations, Establishing a Hematopoietic Stem Cell Transplantation Unit: A Practical Guide is an essential, practical resource for all members of the multidisciplinary hematopoietic stem cell transplantation team.
Book Synopsis Cell and Gene Therapies by : Miguel-Angel Perales
Download or read book Cell and Gene Therapies written by Miguel-Angel Perales and published by Springer. This book was released on 2018-11-27 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee.
Book Synopsis Foundations of Regenerative Medicine by : Anthony Atala
Download or read book Foundations of Regenerative Medicine written by Anthony Atala and published by Academic Press. This book was released on 2009-09-04 with total page 824 pages. Available in PDF, EPUB and Kindle. Book excerpt: The interdisciplinary field of regenerative medicine holds the promise of repairing and replacing tissues and organs damaged by disease and of developing therapies for previously untreatable conditions, such as diabetes, heart disease, liver disease, and renal failure. Derived from the fields of tissue engineering, cell and developmental biology, biomaterials science, nanotechnology, physics, chemistry, physiology, molecular biology, biochemistry, bioengineering, and surgery, regenerative medicine is one of the most influential topics of biological research today. Derived from the successful Principles of Regenerative Medicine, this volume brings together the latest information on the advances in technology and medicine and the replacement of tissues and organs damaged by disease. Chapters focus on the fundamental principles of regenerative therapies that have crossover with a broad range of disciplines. From the molecular basis to therapeutic applications, this volume is an essential source for students, researchers, and technicians in tissue engineering, stem cells, nuclear transfer (therapeutic cloning), cell, tissue, and organ transplantation, nanotechnology, bioengineering, and medicine to gain a comprehensive understanding of the nature and prospects for this important field. Highlights the fundamentals of regenerative medicine to relate to a variety of related science and technology fields Introductory chapter directly addresses why regenerative medicine is important to a variety of researchers by providing practical examples and references to primary literature Includes new discoveries from leading researchers on restoration of diseased tissues and organs
Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by : World Health Organization
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2019-05-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.
