November 2017                               EudraVigilance Change Management

EMA will launch a new EudraVigilance system with enhanced functionalities for

reporting and analysing suspected adverse reactions.

This conference will highlight how the use of the new EudraVigilance web application

(EVWEB) can help Companies to achieve the effective safety system required by the

law, especially under the new GVP guidance and EVWEB and EVDAS.


Conference Focus

- EVDAS – How to manage and to integrate into the own Signal Evaluations?

- EVWEB system - Understand how it could improve the Signal detection process

- How to approach Signal Detection and Risk Management Today?


Who Should Attend

The conference is aimed to users of EudraVigilance and to all professionals involved in

the Signal detection.


08:30-9:30 Registration


09:30-09:40 Chairperson’s opening remarks

Dr. Fernanda Ferrazin – Former Head Pharmacovigilance Dept - Italian Medicines Agency


09:40-10:00 Opening Keynote - Complexity of Pharmacovigilance Management Today “Keep up with continuous changes in legislation and new technologies” 

Dr. Marco Sardella - Chief Pharmacovigilance Officer & EU QPPV ADIENNE Pharma & Biotech


10:00-11:00 New EVWEB/ ISO-ICSR/ XEVMPD - Major changes

Dr. Calin Lungu CEO DDCS - EV Trainer


11:00-11:20 Morning Coffee/Tea & Networking 


11.20-12.10 EVDAS and Download Manager - Additional tools to assist MAHs in Signal Detection

Dr. Calin Lungu - CEO DDCS - EV Trainer


12:10-13:00 Agency Perspective: News on Eudravigilance and PhV National System

Dr. Laura Sottosanti - PhV Department - Italian Medicines Agency


13:00 – 14:20  Networking Luncheon


14:20 – 15:20  How to approach Signal Detection, Signal Assessment and Risk Management Today

Glyn Belcher - Director of PV Consultancy Ltd former Vice President of Biogen Head of International Drug Safety and Risk Management, EU QPPV


15:20 – 15:40 How to meet the worldwide PharmacoVigilance requirements with the safety database SafetyDrugs 6 – Dr. Carlo Ghiglione Project manager, Dr. Andrea Garlanda Marketing manager - Max Application


15:40 – 16:30 Round Table

  • What impact will have the new Eudravigilance and Signal Detection Requirements on Pharmacovigilance activities?
  • What role will have the PhV National System after the go live of the new
  • Eudravigilance system?
  • How to Best Address/Prioritize changes to PV Systems to maintain compliance with the new Eudravigilance and Signal Detection Requirements?


Moderator: Dr. F. Ferrazin

Round table: Meeting participants, Key Speakers and external members

Dr. Margherita D’Antuono - QPPV- Italfarmaco S.p.A.

Dr. Alessandra Del Porto – Farmacovigilanza Drug Safety Director MSD

(Italia) S.r.l., Essex Italia S.r.l.

Dr. Valentina Mancini - Manager Pharmacovigilance Southern Europe

Baxter S.p.A

Dr. Ugo Moretti - Responsible of Pharmacovigilance Regional Center of Veneto

Dr. Gianni Navalesi -Scientific Director Pharma D&


16:30 – 17:00 Afternoon Refreshment Break – Networking & Exhibit


17:00 – 17:20 Chairperson’s closing remarks and end of conference