Summary
In a continuously growing pharmacovigilance environment, there is an increasing demand for a high-quality level of data entry and medical evaluation leading to ICSRs of high quality.
In this interactive course, you learn how to structure a narrative that captures all relevant clinical and other information to support the reported adverse event and the causality assessment. We discuss a number of ICSRs from various sources (from spontaneous to clinical trials) and assess the causality.
Key words
- Individual Case Safety Reports (ICSRs)
- Narrative writing
- Causality assessment
- Regulatory requirements
- Company Comments
ANNIVERSARY OFFER:
Book any course* scheduled for a date in 2022 and bring a colleague along: 2 for the price of 1. Only valid for bookings made 2 May until 16 May.
Sign up yourself and a colleague in the same order form – then we make sure only one course fee is charged.
(*Networks and courses offered together with University of Copenhagen and CBS are not included.)

Course leader(s) & Lecturer(s)
- Claudia Pierleoni-NielsenCourse leaderSenior Director, Head of Medical Safety
Lundbeck A/S - Terrie Ramirez-AndersenCourse leaderDirector, Clinical Research Scientist
Genmab A/S
IS THIS COURSE FOR YOU?
You work as a professional within pharmacovigilance, and already understand the basic principles of causality assessment.
What you will learn
- You will learn how to critically analyse and assess ICSRs and how to write company comments in the regulatory framework
- You will assess and discuss a number of ICSRs from various sources (from spontaneous to clinical trials) and a variety of medical event types
What your company will get
- An employee who understands the ICSRs’ value and who 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
- Principles of Causality Assessment
- Narrative writing
- Company’s Comments & Regulatory Perspective
- Workshops
- Rounding up
Registration
Registration deadline13 Sep 2022
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 familiarise yourself with the mandatory readings before starting the course.
Course leader(s)
Lundbeck A/S
Genmab A/S
Lecturer(s)
Lundbeck A/S
Genmab A/S
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WANT TO KNOW MORE or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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