Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (Hardcover)

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