<p><b>Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market</b><p>Based on a module prepared by the authors for an MSc course in Technology Management by Distance Learning offered by the University of Limerick, Ireland, <i>Medical Product Regulatory Affairs</i> is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. <p>Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. <p><i>Medical Product Regulatory Affai
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Medieval Ireland is often described as a backward-looking nation in which change only came about as a result of foreign invasions. By examining the wealth of under-explored evidence available, Downham challenges this popular notion and demonstrates what...
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<p>Vikings plagued the coasts of Ireland and Britain in the 790s. By the mid-ninth century vikings had established a number of settlements in Ireland and Britain and had become heavily involved with local politics. A particularly successful viking...
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<P>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...
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<P>This practical guide is the ideal tool for the busy practitioner or speech and language therapist to provide an effective, meaningful, and contextualised approach to language development using picture books. </P><P>Drawing from up-to-date,...
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