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Medical Product Regulatory Affairs - Pharmaceuticals, Diagnostics, Medical Devices (Hardcover, 2nd edition)
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Medical Product Regulatory Affairs - Pharmaceuticals, Diagnostics, Medical Devices (Hardcover, 2nd edition)
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Hands-on guide through the jungle of medical regulatory affairs for
every professional involved in bringing new products to market
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, Medical Product Regulatory Affairs
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. 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. Medical Product
Regulatory Affairs includes information on: Aims and structure of
regulation, covering purpose and principles of regulation, national
and EU legislative processes, and pharmacopeia Regulatory strategy,
covering product development and manufacturing, market vigilance,
quality assurance systems, personnel, and documentation Drug
discovery and development, covering prescription status, physical
properties, therapeutic use, and drug discovery, development, and
delivery Non-clinical studies, covering non-clinical study
objectives and timing, pharmacological and pharmacodynamic studies,
and bioavailability and bioequivalence Clinical trials, covering
trial protocol, monitoring of trials, trial master files, and FDA
communications The wide coverage of different product types and the
main global markets makes Medical Product Regulatory Affairs ideal
for training courses on regulatory affairs in academia and
industry. It is also a valuable reference for pharmacologists,
bioengineers, pharma engineers, and students in pharmacy to
familiarize themselves with the topic.
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