EudraVigilance - electronic reporting of ICSRs in the EEA

Agenda

Day 1 Nov 17, 2014

9:00 AM — 10:30 AM

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

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

EudraVigilance Gateway and WEB Trader, ICSR Validation Business Rules

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

Creating a Safety Message, Saving and Printing Options

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:00 PM

Follow up and Nullification Report

Day 2 Nov 18, 2014

9:00 AM — 7:30 PM

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

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

Study Report, EudraVigilance Business Rules

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

Receiving Acknowledgment Messages, Validation and Creating Acknowledgments

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:45 PM

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

Day 3 Nov 19, 2014

9:00 AM — 10:30 AM

MedDRA Simple and Advanced Queries, ICSR Simple and Advanced Queries

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:00 PM

Questions and review for Knowledge Evaluation

12:00 PM — 1:00 PM

SANDWICH LUNCH

1:00 PM — 4:00 PM

Knowledge Evaluation, Questions

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EudraVigilance - electronic reporting of ICSRs in the EEA

Agenda

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