Agenda

Day 1 May 14, 2018

8:00 AM — 8:30 AM

Introduction

8:30 AM — 9:45 AM

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

9:45 AM — 10:00 AM

COFFEE BREAK

10:00 AM — 12:00 PM

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

12:00 PM — 12:45 PM

LUNCH

12:45 PM — 5:00 PM

Introduction to EVWEB Version 8.0, Creating an ICSR and sending of a safety message, Saving and Printing Options (Coffee break inbetween)

Day 2 May 15, 2018

8:00 AM — 12:00 PM

Practical exercises: amendment-, follow up report, report from a non- interventional study & a SUSAR from an interventional study (coffee break inbetween)

12:00 PM — 12:45 PM

LUNCH

12:45 PM — 1:30 PM

Practical exercise: Nullification of a case report

1:30 PM — 2:30 PM

Creating, sending and receiving acknowledgment messages

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 4:30 PM

Principles of obtaining access to EudraVigilance

4:30 PM — 5:00 PM

Questions & Answers

Day 3 May 16, 2018

8:00 AM — 9:30 AM

Access to EudraVigilance Data: EVDAS and EVWEB (explained & demonstrated)

9:30 AM — 9:45 AM

COFFEE BREAK

9:45 AM — 12:00 PM

ICSR Simple and Advanced Queries, EudraVigilance Export Manager: ICSR download functionality for MAHs

12:00 PM — 12:30 PM

LUNCH

12:30 PM — 2:00 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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