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

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3 Oct 2023

On location

English

6,550 DKK ex VAT

(app. 881 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS
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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.


Keywords

  • 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.)


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Course leader & lecturers

  • Claudia Pierleoni-Nielsen
    Course leader
    Head of Safety Surveillance, Global Safety
    Leo Pharma A/S

Is this course for you?

This course is for you who work with side effect surveillance e.g. as PV specialist, Veterinarian, Clinical Trial Manager, or drug safety specialist, 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

3 Oct 2023 8:30-16:00
  • Principles of Causality Assessment
  • Narrative writing
  • Company’s Comments & Regulatory Perspective
  • Workshops
  • Rounding up

Practical information

Registration

Registration deadline
3 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
3 Oct
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

Claudia Pierleoni-Nielsen
Head of Safety Surveillance, Global Safety
Leo Pharma A/S

Lecturer

Claudia Pierleoni-Nielsen
Head of Safety Surveillance, Global Safety
Leo Pharma 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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