Bringing Advanced Therapy Medicinal Products (ATMPs) to the Clinic and Beyond: How to Ensure the Sustainable and Affordable Introduction of ATMPs Into Healthcare PDF Download
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Author: Hans-Dieter Volk
Publisher: Frontiers Media SA
ISBN: 2832507808
Category : Medical
Languages : en
Pages : 178
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Book Description
Author: Hans-Dieter Volk
Publisher: Frontiers Media SA
ISBN: 2832507808
Category : Medical
Languages : en
Pages : 178
Get Book Here
Book Description
Author: Maria Cristina Galli
Publisher: Springer Nature
ISBN: 3031345673
Category : Science
Languages : en
Pages : 243
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Book Description
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: World Health Organization
Publisher:
ISBN: 9789290360841
Category : Drugs
Languages : en
Pages : 0
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Book Description
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.
Author: The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada
Publisher: Council of Canadian Academies
ISBN: 1926522796
Category : Medical
Languages : en
Pages : 122
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Book Description
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.
Author: Rakesh Sharma
Publisher: BoD – Books on Demand
ISBN: 1789230101
Category : Science
Languages : en
Pages : 353
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Book Description
Stem Cells in Clinical Practice and Tissue Engineering is a concise book on applied methods of stem cell differentiation and optimization using tissue engineering methods. These methods offer immediate use in clinical regenerative medicine. The present volume will serve the purpose of applied stem cell differentiation optimization methods in clinical research projects, as well as be useful to relatively experienced stem cell scientists and clinicians who might wish to develop their stem cell clinical centers or research labs further. Chapters are arranged in the order of basic concepts of stem cell differentiation, clinical applications of pluripotent stem cells in skin, cardiac, bone, dental, obesity centers, followed by tissue engineering, new materials used, and overall evaluation with their permitted legal status.
Author: Giacinto Della Cananea
Publisher:
ISBN: 9782841520992
Category : Administrative agencies
Languages : en
Pages : 199
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Book Description
Author: Wojciech Chrzanowski
Publisher: Royal Society of Chemistry
ISBN: 1839164565
Category : Technology & Engineering
Languages : en
Pages : 255
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Book Description
Extracellular and biofluids vesicles (EVs) are highly specialised yet ubiquitous nanoscale messengers secreted by cells. With the development of stem cell engineering, EVs promise to deliver next generation tools in regenerative medicine and tissue engineering, as well as in diagnostics. A vibrant and promising field, this book provides the first resource to the field. Covering basic cell biology, including EV production and intracellular communication, this book will provide material scientists and engineers with a foundation to the necessary biology. The reader will then learn about the isolation of extracellular vesicles their physicochemical characterisation and therapeutic application of EVs in regenerative medicine as well as their potential as biomarkers in medical diagnostic. This book will also discuss the regulatory landscape of EVs. Bridging cell biology, biomaterials, biophysics and biomedical engineering the content of this book is written with a broad interdisciplinary audience in mind. Researchers, new and established will find this a must-have on their shelf.
Author: Nicolaus Kröger
Publisher:
ISBN: 9781013273667
Category : Medical
Languages : en
Pages : 688
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Book Description
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.
Author: Miguel-Angel Perales
Publisher: Springer
ISBN: 3319543687
Category : Medical
Languages : en
Pages : 286
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Book Description
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.
Author: Carsten Werner Lederer
Publisher: Frontiers Media SA
ISBN: 2889716880
Category : Science
Languages : en
Pages : 218
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Book Description
Dr. Miccio holds patents related to viral gene delivery vectors. The Topic Editors acknowledge the use of image material from kindpng.com and from Crystal and Annie Spratt on unsplash.com.
