Summary
Understand the principles of causality assessment, how to critically analyse and assess ICSRs and how to write company comments in the regulatory framework.
In a continuously growing pharmacovigilance environment, there is an increasing demand of a high quality level of data entry and medical evaluation leading to ICSRs of high quality.
In this course we will cover the principles of causality assessment, the regulatory framework, how and when to write company comments and why ICSRs are important.
The course is interactive and you will have the opportunity to assess and discuss a number of ICSRs from various sources (from spontaneous to clinical trials) and a variety of medical event types.
Keywords
- Individual Case Safety Reports (ICSRs)
- Causality assessment
- Regulatory requirements
- Company Comments
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Course leader(s) & Lecturers
- Claudia Pierleoni-NielsenCourse leaderSenior Director, Head of Medical Safety
Lundbeck A/S - Terrie Ramirez-AndersenCourse leaderDirector, Global Drug Safety & Pharmacovigilance
Genmab A/S
IS THIS COURSE FOR YOU?
This course is relevant for all pharmacovigilance professionals - from case handling to advisers and both for newcomers in the pharmacovigilance area as well as more experienced pharmacovigilance professionals.
What you will learn
- The principles of causality assessment
- How to analyse and critically evaluate ICSRs from various sources
- When and how to write company comments
- Regulatory requirements of ICSRs
What your company will get
- A pharmacovigilance professional who understands the ICSRs’ value and can critically analyse and assess ICSRs
- A pharmacovigilance professional who knows when and how to write comments to ICSRs
- A pharmacovigilance professional who can provide valuable input to all other team members working with ICSRs
Course calendar
DAY 1
- Methods to determine causal relationship and principles of causality assessment
- Company comments and regulatory background
- Workshop on cases assessment and company comments writing
Registration
Registration deadline19. Nov 2021
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
Examination
There is no examination for this course.
Course leader(s)
Lundbeck A/S
Genmab A/S
Lecturers
Lundbeck A/S
Genmab A/S
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WANT TO KNOW MORE or need help?
Contact Client Manager Ida Salicath at +45 39 15 09 46
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