EudraVigilance Course

13.03.2019 - 15.03.2019

LEARNING OBJECTIVES

By the end of this training course, participants should be able to:

• Describe the EudraVigilance System components

• Apply ISO/ICH E2B(R3) rules to safety reporting based on practical examples for initial and follow-up reports, amendment and nullification reports, literature and parent-child cases, and reports from studies

• Understand how to use EVWEB to create, send and access ICSRs and acknowledgements

• Describe the principles of EVDAS and access by MAHs to use electronic Reaction Monitoring Reports (e-RMRs), line listings and ICSR forms

• Query, view, browse and download ICSRs using the EudraVigilance ICSR Download Functionality, which provides access by marketing authorisation holders (MAHs) to ICSRs submitted by National Competent Authorities (NCAs) in the EEA.

 

 TARGET AUDIENCE

• Users of EudraVigilance - new users and users already trained on working with EudraVigilance including

• The EU pharmacovigilance legislation

• GVP Module VI - Management and reporting of adverse reactions to medicinal products

• Guidance documents related to the monitoring of safety of clinical trials (CT3)

• GVP Module IX - Signal management and revised guidance on statistical methods  

 

Further information on the new EudraVigilance system training can be found on the dedicated EMA EudraVigilance training page.

Please register online at www.diaglobal.org/en/cart.

Anmeldeinformationen:
Please register online at www.diaglobal.org/en/cart
Verantwortlich für Programm:
basel@DIAglobal.org
Ansprechpartner für Veranstaltung:
DIA Europe, Middle East and Africa Contact Centre Team
Tel: +41 61 225 51 51
Ort: AGES
Spargelfeldstrasse 191
A-1220 Vienna
AUSTRIA
Veranstaltungsart: hands-on training course

Kosten: 1.850 EUR (925 EUR for academia/charitable/government/non-profit)

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