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Guest Post.

We know pharmacovigilance is a critical part of drug development. Click on the below links to know about ICSR processing, Aggregate Reporting, and Signal Management.

Individual Case Study Report (ICSR) is an adverse event report for an individual patient and is the source of data in pharmacovigilance. 

2. Overview of Pharmacovigilance

3. History and evolution of Pharmacovigilance

4. Drug discovery and development process:

5. Terms, Definitions and Examples for Adverse Event Reporting:

6. Spontaneous/voluntary Adverse event reporting:

Clinical Trials Transformation – Decentralized Clinical Trials

8. Post-marketing study (PMS)

9. Literature reports

10. License partner and Regulatory authority reports

11. What is valid ICSR?

12. Adverse event process flow

13. Regulatory Reporting

14. ICSR processing of Clinical trial cases:

15. Duplicate search in Pharmacovigilance

16. Seriousness assessment of adverse event reports

17.i. MedDRA learning series – Understanding MedDRA

17.ii. MedDRA learning series – coding with MedDRA

17.iii. MedDRA learning series – coding with MedDRA

18. i. Listedness/Expectedness assessment – Introduction

18.ii. LISTEDNESS/ EXPECTEDNESS ASSESSMENT – Reference safety information documents

18.iii. LISTEDNESS/ EXPECTEDNESS ASSESSMENT – Guidelines and Examples

19. Causality Assessment

20. Scale for Causality Assessment

21. Narrative writing

22. Case Follow-up

23. Aggregate reporting – Introduction

24. Aggregate reporting- IND annual reports

25. CSR reports

26. NDA and ANDA Annual reports

27. Development safety update report (DSUR)

28. Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) and Periodic Adverse Drug Experience Report (PADER) – Introduction

29. Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER)

30. Periodic Adverse Drug Experience Report (PADER/PAER)

31. Safety Signal – Introduction

32. Signal Management – Signal detection

33. Signal validation

36. Recommendation for Action and Exchange of Information

38. Risk benefit evaluation process – Overview

39. Evaluation of benefits

40. Medicine Safety Plans – RMP and REMS

41. Safety Signal Detection Methods – Data Mining approach

42. Data Mining: Proportional Reporting Ratio

43. Reporting Odds Ratio (ROR)

44. Relative reporting ratio (RRR)

45. Chi-square (χ2)

46: The Information Component

47. Bayesian Confidence Propagation Neural Network

48. Multi-Item Gamma Poisson Shrinker (MGPS) algorithm

Traditional methods of signal detection

Adverse event of special interest (AESI)

All the content is from https://allaboutpharmacovigilance.org/pharmacovigilance-guidance-material/icsr-processing-aggregate-reporting-and-signal-management/.

Read https://clinicalresearchinfo.com/list-of-pharmacovigilance-companies-in-india/