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.As a first step, the sponsor is required to prepare an investigatora#39;s brochure (IB). ... It should include a description of the physical, chemical and pharmaceutical properties of the drug substance and product, ... Figure 5.3 A typical clinical trial protocol template (in this case as required by the Irish Medicines Board; www.imb .ieanbsp;...
|Title||:||Medical Product Regulatory Affairs|
|Author||:||John J. Tobin, Gary Walsh|
|Publisher||:||John Wiley & Sons - 2011-08-24|