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.
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
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