Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical DevicesISBN: 978-3-527-31877-3
Hardcover
297 pages
September 2008, Wiley-Blackwell
This is a Print-on-Demand title. It will be printed specifically to fill your order. Please allow an additional 15-20 days delivery time. The book is not returnable.
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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
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