Pharmacovigilance_and_Drug_Safety_Monitoring.pptx

Drug safety

1. Pharmacovigilance and Drug Safety Monitoring Academic Presentation M.Pharm Level

2. Introduction Pharmacovigilance ensures the safety and efficacy of drugs through monitoring adverse effects.

3. Key Components Detection, assessment, understanding, and prevention of adverse drug reactions (ADRs).

4. Sources of Data Clinical trials, spontaneous reporting systems, and electronic health records.

5. Regulatory Agencies WHO-UMC, EMA, USFDA, and CDSCO play vital roles in global drug safety.

6. Tools & Systems EudraVigilance, VigiBase, and FAERS databases.

7. Challenges Underreporting, data quality, and signal validation issues.

8. Recent Developments Use of AI and big data analytics in pharmacovigilance systems.

9. Conclusion Pharmacovigilance safeguards public health by ensuring continuous drug safety evaluation.

10. References 1. WHO Pharmacovigilance Guidelines, 2020. 2. Bate A, et al. Drug Saf. 2018;41(2):143–152.