Tobin, John J. / Walsh, Gary
Medical Product Regulatory Affairs
Pharmaceuticals, Diagnostics, Medical Devices
  1. Edition - July 2008
77.90 Euro
2008. XIV, 283 Pages, Hardcover
114 Fig. (1 Colored Fig.), 39 Tab.
- Textbook -
ISBN-10: 3-527-31877-1
ISBN-13: 978-3-527-31877-3 - Wiley-VCH, Weinheim
Content
Sample Chapter
Index
Short description
All you need to know about regulatory affairs in the major global markets for pharmaceuticals and medical devices.
From the contents
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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