Individual Case Safety Reports (ICSRs) - from narrative writing to causality assessment

Learn to structure a narrative that supports the reported adverse event and the causality assessment

26. Nov 2021

1 day course

Danish

7,000 DKK ex VAT
(app. 941 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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
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Course leader(s) & Lecturers

  • Claudia Pierleoni-Nielsen
    Course leader
    Senior Director, Head of Medical Safety
    Lundbeck A/S
  • Terrie Ramirez-Andersen
    Course leader
    Director, Global Drug Safety & Pharmacovigilance
    Genmab A/S
See all

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

  1. You will learn how to critically analyse and assess ICSRs and how to write company comments in the regulatory framework
  2. 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

  1. An employee who understands the ICSRs’ value and who can critically analyse and assess ICSRs
  2. A pharmacovigilance professional who knows when and how to write comments to ICSRs
  3. A pharmacovigilance professional who can provide valuable input to all other team members working with ICSRs

Course calendar

26. Nov 2021 9:00-16:00
  • Principles of Causality Assessment
  • Narrative writing
  • Company’s Comments & Regulatory Perspective
  • Workshops
  • Rounding up

Practical information

Registration

Registration deadline
26. Nov 2021
Atrium
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

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)

Claudia Pierleoni-Nielsen
Senior Director, Head of Medical Safety
Lundbeck A/S
Terrie Ramirez-Andersen
Director, Global Drug Safety & Pharmacovigilance
Genmab A/S

Lecturers

Claudia Pierleoni-Nielsen
Senior Director, Head of Medical Safety
Lundbeck A/S
Terrie Ramirez-Andersen
Director, Global Drug Safety & Pharmacovigilance
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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