Medical product regulatory affairs: pharmaceuticals, diagnostics, medical devices

All you need to know about regulatory affairs in the major global markets forpharmaceuticals and medical devices. INDICE: 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

• ISBN: 978-3-527-31877-3
• Editorial: Verlag Chemie
• Encuadernacion: Cartoné
• Páginas: 260
• Fecha Publicación: 21/05/2008
• Nº Volúmenes: 1
• Idioma: Inglés