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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 Apr 2025

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On location

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English

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7,100 DKK ex VAT

(app. 955 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS
Home > Courses > Individual Case Safety Reports (ICSRs) - from Narrative Writing to Causality Assessment

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 medical review of ICSRs. We discuss a number of ICSRs from various sources (from spontaneous to clinical trials). You will also get familiar with the regulatory requirements behind narrative writing, causality assessment and reportability.


    Keywords

    • Individual Case Safety Reports (ICSRs)
    • Narrative writing
    • Causality assessment
    • Regulatory requirements
    • Company Comments

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    Course leader & lecturers

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

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    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. How to write a good case quality narrative and company comments in line with regulatory requirements
    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 value of ICSRs, the importance of a good quality narrative and who can critically analyse and assess ICSRs
    2. A pharmacovigilance professional who can provide valuable input to all other team members working with ICSRs

    Course calendar

    3 Apr 2025 9:00-16:00
    • Narrative writing
    • Principles of Causality Assessment
    • Company’s Comments & Regulatory Perspective
    • Workshops
    • Rounding up

    Practical information

    Registration

    Registration deadline
    27 Mar 2025
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    3 Apr
    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
    Director, 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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