TY - BOOK TI - Good pharmacovigilance practice guide SN - 9780853698340 U1 - 615.7 21 PY - 2009///] CY - London PB - Pharmaceutical Press KW - Drug monitoring KW - Handbooks, manuals, etc N1 - Includes index; 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 UR - http://repository.fue.edu.eg/xmlui/handle/123456789/1551 ER -