Case Management Training Course
This intensive 2-day training course teaches you about the handling of pharmacovigilance cases and reports. You will learn to evaluate reports for credibility and eliminate repetitions by updating information that is already present in the database. You will also learn how information is obtained for each peculiar case.
Pharmacovigilance case handling training helps you with clinical trials, documentation, data analysis, and the safe handling of drugs. Training for PV case handling will include a detailed discussion on the scope of PV, the steps involved in the entire process, and all the guidelines that must be followed in each process step.
Dates: 28th – 29th January 2025
12.00 pm – 17.00 pm (London, UK)
What you will learn:
- To understand the requirements of Clinical drug safety and Post-Authorisation case processing and expedited reporting
- To acquire the skills necessary for producing well written case reports including narrative writing
- To acquire analytical skills for assessing causality, expectedness / listedness and seriousness for Individual Case Safety Reports (ICSRs)
Programme
Agenda
Day 1 – Tuesday 28th January 2025
12.00pm – 12.10pm Introductions
Reni Kunkel, Global PV Operations Manager, IntuVigilance
12.10pm – 12.40pm Pharmacovigilance Legal Background (focus on ICSR collection and reporting)
Reni Kunkel, Global PV Operations Manager, IntuVigilance
- European and International regulatory bases and requirements
- Individual Case Safety Repots (ICSRs) handling Background and scope
- Working group recommendations (CIOMS and ICH)
12.40pm – 12.50pm Review and Questions
12.50pm – 13.20pm Post-marketing reporting
Henna Gupta, Project Manager, IntuVigilance
- Spontaneous reporting rational
- Sources and types of adverse events and other safety information
- The different stakeholders involved in the ICSRs handling
- Spontaneous reporting process overview
13.20pm – 13.30pm Review and Questions
13.30pm – 13.40pm Refreshment Break
13.40pm – 14.10pm Clinical trial cases
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
- Roles and Responsibilities of Investigators and Sponsors
- Roles and Responsibilities of monitors for drug safety teams
- Safety Involvement in Clinical trials
- Unblinding process overview and rational
- ICSRs reporting in clinical trials
14.10pm – 14.20pm Review and Questions
14.20pm – 14.50pm Case assessment and evaluation – Part 1
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
- Case Validation
- Review of the 5 pillars for a case evaluation:
- AE type
- Seriousness
- Causality
- Expectedness / listedness
- Preventability
14.50pm – 15.00pm Review and Questions
15:00pm – 15.20pm Case assessment and evaluation – Part 2
Henna Gupta, Project Manager, IntuVigilance
- Case Validation
- Review of the 5 pillars for a case evaluation:
- AE type
- Seriousness
- Causality
- Expectedness / listedness
- Preventability
15.20pm – 15.30pm Review and Questions
15.30pm – 15.40pm Refreshment Break
15.40pm – 16.10pm Safety databases, MedDRA and WHO drug coding – Part 1
Henna Gupta, Project Manager, IntuVigilance
- The management and use of safety databases
- MedDRA coding:
- What is MedDRA and How is it Used?
- Getting Started with MedDRA
- Introduction to the Points to Consider Documents
- MedDRA Structure and Scope
- MedDRA Coding Basics
- Data Quality
16.10pm – 16.50pm Safety databases, MedDRA and WHO drug coding – Part 2
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
- The management and use of safety databases
- MedDRA coding:
- What is MedDRA and How is it Used?
- Getting Started with MedDRA
- Introduction to the Points to Consider Documents
- MedDRA Structure and Scope
- MedDRA Coding Basics
- Data Quality
16.50pm – 17.00pm Review and Questions
Day 2 – Wednesday 29th January 2025
12.00pm – 12.10pm Recap
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
12.10pm – 12.40pm Narrative writing
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
- Introduction & regulatory context
- Reason for writing narrative
- Format and content of narrative in ICSR
12.40pm – 12.50pm Review and Questions
12.50pm – 13.20pm Narrative writing – Workshop
Harpreet Koasha, Senior Pharmacovigilance Manager, IntuVigilance
13.20pm – 13.30pm Review and Questions
13.30pm – 13.40pm Refreshment Break
13.40pm – 14:20pm Medical Review and Causality Assessment
Dr Ahmed Hegazy
- Causality
- Seriousness
- Coding of Medical terms
- Company content
- Medical sense
14.20pm – 14:30pm Review and Questions
14:30pm – 14.40pm Refreshment Break
14.40pm – 15.10pm Expedited reporting
Reni Kunkel, Global PV Operations Manager, IntuVigilance
- Understanding Reporting requirements as a requirement for expedited reporting, how expedited reporting should be handled and a glimpse into how this is done across the world
15.10pm – 15.20pm Review and Questions
15:20pm – 15:45pm VigiBase
Speaker from Uppsala Monitoring Centre (TBC)
15.45pm – 16:15pm Practical Workshop
Henna Gupta, Project Manager, IntuVigilance
16:15pm – 16:25pm Review and Questions
