Essentials of Drug Safety
The Essentials of Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings, how to assess cases for seriousness, expectedness and causality, and how to report adverse events cases.
Course Content:
- Learning Objectives for this Module
- History of Pharmacovigilance
- Pre-Marketed AEs
- Post-Marketed AEs
- Pre- and Post-marketing: Basic Differences
- The Importance of Adverse Event Reporting
- Pharmacovigilance Definitions
- ICH Definition of Adverse Event
- ICH Definition of Adverse Drug Reaction
- Suspected Unexpected Serious Adverse Reaction
- Sources of ADRs
- Pharmacovigilance Process
- Assessing Adverse Events
- Regulatory Definition of a Serious Adverse Event
- Severity/Intensity
- Difficulty Assessing Relationship of AEs with Drug
- Causality
- Lack of Efficacy
- Expectedness
- Assessing Expectedness/Labeledness/Listedness
- Labeled vs. Listed
- General Types of Reports
- Expedited Reporting – What to Report
- Expedited Reporting – What not to report
- Aggregate Reports – Common Types
- Reporting Timeframes for ICSRs
- Timelines for Follow-Up
- Reporting to IRB/ECs
- Investigator Notification
- Minimum Criteria for Reporting
- Minimum Data Set – Day “0”
- Reporting Format
- Key Data Elements for Inclusion in Expedited Reports
- Managing Blinded Therapy Cases
- Special cases
- Adverse Reaction Types
- Safety Signal Generation: Definition
- Pharmacovigilance Process
- Quiz on Module 1