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OTEAcademy

May 27, 2013 9:00 AM - May 29, 2013 5:00 PM

Pelika & Spartis 1, Maroussi , 151 22 Athens, Greece

Electronic reporting of ICSRs in the EEA

Agenda

9:00 AM10:30 AM

Concepts of Electronic Transmission of ICSRs, Introduction to EudraVigilance,Registration with EudraVigilance, Clinical Safety Data Management and Transmission of ICSRs - ICH E2B(R2)

11:00 AM12:30 PM

EudraVigilance Gateway and WEB Trader, ICSR Validation Business Rules

1:30 PM3:30 PM

Creating a Safety Message, Saving and Printing Options

4:00 PM6:00 PM

Follow-up Report, Nullification Report

9:00 AM10:30 AM

Literature Report, Parent-child Report, Report with Medical and Drug History

11:00 AM12:30 PM

Study Report, EudraVigilance Business Rules

1:30 PM3:30 PM

Receiving Acknowledgment Messages, Validation and Creating Acknowledgments

4:00 PM5:45 PM

WEB Trader - Post Function, What To Do in the Event of System Failure

9:00 AM10:30 AM

MedDRA Simple and Advanced Queries, ICSR Simple and Advanced Queries

11:00 AM12:00 PM

Questions and review for Knowledge evaluation

1:00 PM4:00 PM

Knowledge Evaluation: Multiple Choice and ICSR Exam Case

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