Agenda

Day 1 Mar 04, 2020

9:00 AM — 9:30 AM

Introduction

9:30 AM — 10:30 AM

Introduction to the New EudraVigilance System: components & functionalities, Changes in EV registration proces, Re-Routing of ICSRs to NCAs in the EEA, ICSR download for MAHs

10:30 AM — 10:45 AM

COFFEE BREAK

10:45 AM — 12:30 PM

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 — 3:45 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 Mar 05, 2020

9:00 AM — 10:30 AM

Practical exercise: Follow-up report, Amendment report

10:30 AM — 10:45 AM

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 — 4:00 PM

COFFEE BREAK

4:00 PM — 5:30 PM

Principles of obtaining access to EudraVigilance

5:30 PM — 6:00 PM

Questions & Answers

Day 3 Mar 06, 2020

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

10:30 AM — 10:45 AM

COFFEE BREAK

10:45 AM — 12:00 PM

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

12:00 PM — 12:30 PM

SANDWICH LUNCH

12:30 PM — 2:00 PM

KNOWLEDGE EVALUATION: Multiple Choice & Practical exam

Have an account?

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Agenda

Be informed and stay engaged.