Overview

This one day course covers the pre-requisites for the three day training course on EudraVigilance - electronic reporting of ICSRs in the EEa and is therefore recommended to newcomers in pharmacovigilance, in particular individuals dedicated to data entry and expedited reporting. The attendees will learn about the essentials of pharmacovigilance, the format, structure and content of ICSRs as well as rules for expedited reporting in Europe for both Clinical Trials and Post-Marketing ICSRS.

Featured topics

Legal/regulatory basis
Compliance with reporting requirements for ICSRs
What is a pharmacovigilance case: scope, criteria for validity
Classification of cases: Solicited/ unsolicited, serious/not serious, etc
Overview of the ICH E2B requirements
Main differences of data elements and adverse reaction reporting during clinical trials and in the postauthorisation phase
Overview of the case flow in the EU
Concepts and data elements of an ICSR (the main part of the training, focusing on content and quality
criteria of each important element)
Case Follow-up: when and how it needs to be transmitted.
Basic coding principles
Data privacy requirements

Who should attend?

This course is intended for newcomers in pharmacovigilance, who need to understand the basics of ICSRs with main focus on EU requirements.

Learning objectives

Participants who complete this course should be able to:

Understand the ICSR reporting requirements
Understand the basic vocabulary of pharmacovigilance
Complete properly the components of an ICSR
Compare ICSR components for post-authorisation and clinical trials
Identify the resources available for further guidance

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Introduction to Pharmacovigilance and Rules for Expedited Reporting of Individual Case Safety Reports (ICSRs) in Europe

Overview

Featured topics

Who should attend?

Learning objectives

Be informed and stay engaged.