Medical evaluation of Individual Case Safety Reports (ICSRs)

Learn how to evaluate Individual Case Safety Reports (ICSRs) and prepare the ideal sender comment

26. Nov 2021

1 day course

English

3,600 DKK ex VAT
(app. 484 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

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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
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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

  1. The principles of causality assessment
  2. How to analyse and critically evaluate ICSRs from various sources
  3. When and how to write company comments
  4. Regulatory requirements of ICSRs

What your company will get

  1. A pharmacovigilance professional who understands the ICSRs’ value and 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 12:00-17:00

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
Practical information

Registration

Registration deadline
19. 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 familiarize yourself with the mandatory readings before starting the course.

Examination

There is no examination for this 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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