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Handbook of Medical Device Regulatory Affairs in Asia
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Artikel-Nr:
9789814411219
Veröffentl:
2013
Erscheinungsdatum:
27.03.2013
Seiten:
616
Autor:
Jack Wong
Gewicht:
965 g
Format:
236x159x40 mm
Sprache:
Englisch
Beschreibung:
Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007.
With a focus on Asian countries, this handbook covers medical device regulatory systems in different regions, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Each chapter provides substantial background materials relevant to the particular area to provide readers with a better understanding of regulatory affairs. With contributions from authors working with regulatory bodies around the world, the handbook explains the basics of the Asian market and how to best access it. It also guides product developers through the global regulatory environment.
Introduction. Medical device safety and related ISO Standards. Harmonization of Medical Device in Asia. US and EU Regulatory System. Regulation in Asia-Pacific Countries.