Book description
Written in a clear and concise style by an experienced author, this
attractively-priced book covers regulatory affairs in all major global
markets for pharmaceuticals and medical devices, making it the most
comprehensive in its field.
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.
Everything pharmacologists, bioengineers, pharma engineers, students in
pharmacy and those working in the pharmaceutical industry need to know
about medical regulatory affairs. J. J. Tobin worked for many years
and in various capacities within Olympus diagnostica GmbH, a company
employing several 100 people who develop and manufacture in vitro
diagnostic reagents. Dr. Tobin therefore has extensive experience of
working within an FDA and European medical device regulatory framework.
Gary Walsh is a senior lecturer in industrial biochemistry at the
University of Limerick, Ireland. He has direct industrial experience
within the pharmaceutical industry, as well as extensive teaching and
non-laboratory based research interests in the pharmaceutical
biotechnology arena. He has published a number of books, book chapters
and journal articles relevant to this publication. He also teaches
elements of pharmaceutical science and regulatory affairs on an annual
course provided by the University of Limerick to an international
medical device company with a manufactoring facility based in the
region.
