"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." -Microbiology Today, May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and 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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers 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.
What is a drug, and what is a device? Basic principles and definitions of healthcare products The regulatory framework: FDA, EMEA, other regulatory authorities The drug development process: pre-clinical and clinical studies Medical devices: design control, validation, risk management Regulatory submissions: forms and requirements Quality systems: GMP, ISO norms, software validation Post-marketing issues: surveillance, corrective and preventive actions World harmonization of regulatory requirements