Author: Hans-Dieter Volk
Publisher: Frontiers Media SA
ISBN: 2832507808
Category : Medical
Languages : en
Pages : 178

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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: 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: 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: Stefania Boccia
Publisher: Springer Nature
ISBN: 3030523993
Category : Medical
Languages : en
Pages : 135

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Book Description
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.

Author: Dr Wojciech Chrzanowski
Publisher: Royal Society of Chemistry
ISBN: 178801894X
Category : Technology & Engineering
Languages : en
Pages : 358

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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: Giacinto Della Cananea
Publisher:
ISBN: 9782841520992
Category : Administrative agencies
Languages : en
Pages : 199

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Book Description

Author: Nicolaus Kröger
Publisher:
ISBN: 9781013273674
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: Monique Hennink
Publisher: SAGE
ISBN: 1446259560
Category : Social Science
Languages : en
Pages : 330

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Book Description
Lecturers, click here to request an e-inspection copy of this text Qualitative Research Methods is based on the authors′ highly successful multidisciplinary qualitative methods workshops, which have been conducted for over a decade. In this book the authors propose a ′qualitative research cycle′ that leads students through the selection of appropriate methods, the collection of data and the transformation of findings into a finished project. It provides a clear explanation of the nature of qualitative research and its key concepts. Topics covered include: o formulating qualitative research questions o ethical issues o in-depth interviews o focus group discussions o observation o coding o data analysis o writing up qualitative research This text is ideal for any students taking a qualitative methods course or producing a qualitative research project at undergraduate or graduate level. It is illustrated throughout with case studies and field examples from a range of international contexts. The practical techniques are also accompanied by the author′s own research tools including interview guides, real coded data and comprehensive research checklists.

Author: European Directorate for the Quality of Medicines & Healthcare
Publisher:
ISBN: 9789287176394
Category : Cell transplantation
Languages : en
Pages : 320

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Book Description
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