Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 3rd EditionКНИГИ » ЗДОРОВЬЕ И МЕДИЦИНА
Название: Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, Third Edition Автор: Edited By Jack Wong, Raymond K. Y. Tong Издательство: Jenny Stanford Publishing Pte. Ltd Год: 2022 Формат: True PDF Страниц: 804 Размер: 30.1 Mb Язык: English
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Drug Products for Clinical Trials, 2nd Edition Автор: Donald Monkhouse and Charles F. Carney Название: Drug Products for Clinical Trials, 2nd Edition Издательство: CRC Press Год: 2006 ISBN:...
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Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 3rd Edition 
