PHARMACOVIGILANCE – Course Code – BP805ET – For Final Year BPharm – Semester 8 | Dr. DK Tripathi, Dr. Shiv Shankar Shukla | Nirali Prakashan

1. Introduction to Pharmacovigilance,

2. Introduction to Adverse Drug Reactions,

3. Basic Terminologies used in Pharmacovigilance,

4. Drug and Disease Classification,

5. Drug Dictionaries and Coding in Pharmacovigilance,

6. Information Resources in Pharmacovigilance,

7. Establishing Pharmacovigilance Programme,

8. Vaccine Safety Surveillance,

9. Pharmacovigilance Methods,

10. Communication in Pharmacovigilance,

11. Statistical Methods for Evaluating Medication Safety Data Generation,

12. ICH Guidelines for Pharmacovigilance,

13. Pharmacogenomics of Adverse Drug Reactions, Drug Safety Evaluation in Special Population,

14. CIOMS,

15. CDSCO (India) and Pharmacovigilance.

* Bibliography

* Index