Good pharmacovigilance practice guide /
Good pharmacovigilance practice guide /
compiled by the Medicines and Healthcare products Regulatory Agency.
- xviii, 211 pages ; 25 cm
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.
9780853698340
Drug monitoring --Handbooks, manuals, etc.
615.7 / G.
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.
9780853698340
Drug monitoring --Handbooks, manuals, etc.
615.7 / G.