Algebra Center

2018 年 05 月 14 日 7:00 上午 - 2018 年 05 月 16 日 11:00 下午

Ilica 242 , Entrance from Domobranska street, Zagreb, 10000, Croatia (Hrvatska)

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

This hands-on training covers the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format.

会议日程

8:00 AM8:30 AM

Introduction

8:30 AM9:45 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 AM10:00 AM

COFFEE BREAK

10:00 AM12:00 PM

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

12:00 PM12:45 PM

LUNCH

12:45 PM5:00 PM

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

8:00 AM12:00 PM

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

12:00 PM12:45 PM

LUNCH

12:45 PM1:30 PM

Practical exercise: Nullification of a case report

1:30 PM2:30 PM

Creating, sending and receiving acknowledgment messages

2:30 PM3:00 PM

COFFEE BREAK

3:00 PM4:30 PM

Principles of obtaining access to EudraVigilance

4:30 PM5:00 PM

Questions & Answers

8:00 AM9:30 AM

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

9:30 AM9:45 AM

COFFEE BREAK

9:45 AM12:00 PM

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

12:00 PM12:30 PM

LUNCH

12:30 PM2:00 PM

KNOWLEDGE EVALUATION: Multiple Choice & Practical exam

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