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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.

Genetics --- Histology. Cytology --- Human genetics --- medische genetica --- genetica --- cytologie --- histologie --- Cytology. --- Medical genetics. --- Genetics. --- Cell Biology. --- Medical Genetics. --- Clinical Genetics.

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Electrocardiography has an ever-expanding role in pediatric cardiology evaluation. The specific competencies required for its optimal use in this setting, however, generally lie beyond the expertise of cardiologists used to dealing with adults. This guide – the product of extensive practical experience in the field of pediatric cardiology – proposes a very simple method for reading neonatal and pediatric ECGs that is based on the application of straightforward criteria and permits the immediate recognition of normal and pathological patterns. The first part of the guide presents and describes this methodology and the parameters of normal pediatric ECGs, while the second part focuses on specific pediatric anomalies. More than 150 ECGs displaying both normal and pathologic findings are included, all of which have been collected from clinical practice and analyzed using the proposed method. This book will be an invaluable reference tool for all cardiologists who deal with newborns and children.

Hygiene. Public health. Protection --- Paediatrics --- Pathology of the circulatory system --- gezondheidszorg --- pediatrie --- cardiologie --- neonatologie --- Electrocardiography. --- Pediatric cardiology.