Good pharmacovigilance practice guide

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism andtraditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilanceis particularly concerned with adverse drug reactions. This text complements current legislation and guidance and provides practical advice about achievingan appropriate system of pharmacovigilance. INDICE: 1. EEA Qualified Person Responsible for Pharmacovigilance: 2. Management of Pharmacovigilance Data: 3. Spontaneous Case Processing: 4. Literature Searching: 5. Periodic Safety Update Reports: 6. Evaluation of Safety Data: 7. Risk Management Plans: 8. Reference Safety Information: 9. Quality Management System: 10. Interactions Between Pharmacovigilance and Other Functions: 11.Contracts and Agreements: 12. Safety Reporting for Clinical Trials: Annexes

• ISBN: 978-0-85369-834-0
• Editorial: Pharmaceutical Press
• Encuadernacion: Rústica
• Páginas: 256
• Fecha Publicación: 01/11/2008
• Nº Volúmenes: 1
• Idioma: Inglés