Agenda

Day 1 May 15, 2019

9:00 AM — 6:30 PM

Introduction

9:30 AM — 10:30 AM

Introduction to the New EudraVigilance System: components and functionalities, Re-Routing of ICSRs to NCAs in the EEA, ICSR download for MAHs

10:30 AM — 9:15 PM

COFFEE BREAK

10:30 AM — 10:45 AM

COFFEE BREAK

10:45 AM — 11:45 AM

Key elements of the new ICSR in ISO/ ICH E2B(R3) format, ICSR/ EudraVigilance users and access rights

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 3:30 PM

Introduction to EVWEB Version 8.0

3:30 PM — 4:30 PM

COFFEE BREAK

3:45 PM — 6:00 PM

Practical exercise: Creating an ICSR and sending of a safety message, Saving and Printing Options

Day 2 May 16, 2019

9:00 AM — 10:30 AM

Practical exercise: Follow-up report, Amendment report

10:30 AM — 9:15 PM

COFFEE BREAK

10:45 AM — 12:30 PM

Practical exercise: Report from a non-interventional study, Report of a SUSAR from an interventional clinical trial

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

Practical exercise: Nullification of a report

2:30 PM — 3:30 PM

Creating, sending and receiving acknowledgment messages

3:30 PM — 4:30 PM

COFFEE BREAK

4:00 PM — 6:00 PM

Principles of obtaining access to EudraVigilance

5:30 PM — 6:30 PM

Questions & Answers

Day 3 May 17, 2019

9:00 AM — 10:30 AM

Access to EudraVigilance Data: EVDAS and EVWEB, e-RMRs- explained, Line Listings of ICSRs explained & demonstrated, ICSR forms explained & emonstrated

10:45 AM — 12:00 PM

ISCR simple and advanced queries, EudraVigilance Export Manager, EV Post Function, What to do in case of failure

12:00 PM — 1:00 PM

SANDWICH LUNCH

12:30 PM — 1:30 PM

KNOWLEDGE EVALUATION: Multiple Choice & Practical exam

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The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format

Agenda

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