- Overview of Pharmacovigilance
- History and evolution of Pharmacovigilance
- Drug discovery and development process
- Terms, Definitions and Examples for Adverse Event Reporting
- Spontaneous/voluntary Adverse event reporting
- Clinical Research
- Clinical trial transformation – Decentralised trials
- Post-marketing study (PMS)
- Literature reports
- License partner and Regulatory authority reports
- What is valid ICSR?
- Adverse event process flow
- Regulatory reporting
- ICSR processing of Clinical trial cases
- Duplicate search in Pharmacovigilance
- Seriousness assessment of adverse event reports
- MedDRA learning series – Understanding MedDRA
- MedDRA learning series – coding with MedDRA
- MedDRA learning series – coding with MedDRA
- LISTEDNESS/ EXPECTEDNESS ASSESSMENT – Introduction
- LISTEDNESS/ EXPECTEDNESS ASSESSMENT – Reference safety information documents
- LISTEDNESS/ EXPECTEDNESS ASSESSMENT – Guidelines and Examples
- Causality Assessment
- Scale for Causality Assessment
- Narrative writing
- Case Follow-up
- Aggregate reporting
- IND annual reports
- CSR Reports
- NDA and ANDA Annual reports
- Development safety update report (DSUR)
- Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) and Periodic Adverse Drug Experience Report (PADER) – Introduction
- Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Report (PADER/PAER)
- Signal
- Signal Management – Signal detection
- Signal Management -Signal validation
- Signal Management -Signal prioritization
- Signal Management -Signal assessment
- Signal Management -Recommendation for action
- Signal Management -Exchange of information
- Introduction to Benefit risk assessment
- Risk Benefit evaluation process
- Evaluation of benefits
- Medicine Safety plans
- Safety Signal detection methods- data mining
- Data Mining: Proportional Reporting Ratio
- Reporting Odds Ratio (ROR)
- Relative reporting ratio (RRR)
- Chi-square (χ2)
- Information Component (IC)
- Bayesian Confidence Propagation Neural Network
- Multi-Item Gamma Poisson Shrinker
- Traditional methods of signal detection
- Adverse event of special interest