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.
- 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.
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
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
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