Medical evaluation of Individual Case Safety Reports (ICSRs)

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

  • 6. Dec 2018

1 day course

English

3.500,- DKK ex VAT
(app. 471,- EUR ex VAT)

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

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
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Ann Jelert Kristensen at +45 39 15 09 52

Send an email

 

You may also be interested in these courses