Agenda will include:

09:00   09:30     Registration

09:30 - 09:40    Welcome 
                       Paolo Morelli, General Manager and Scientific Director CROSnt

09:40 - 10:10    Requirements for risk management planning, and implementation 
                       of observational studies    read Abstract >>
                        Lesley Wise - Unit Manager Pharmacoepidemiology Research Unit VRMM - MHRA

10:10 - 10:40    Blind Review dei dati: un metodo per aumentare la qualità dell’analisi
                       Lisa Comarella - Head Methodological Biostatistics - CROSnt

10:40 - 11:10    Studi di Fase IV no profit in Italia: un esperienza di studio nel respiratorio
                        Alberto Papi, Direttore Clinica Pneumologica - Università Degli Studi di Ferrara

11:10 - 11:40    Coffee Break

11:40 - 12:10    What does it work in Phase IV studies? 
                       A real experience from the Ethical Commettee point of view
                        Francesco Grigoletto - Università Degli Studi di Padova

12:10 - 12:40    Post Marketing Studies: Added Value and Methodology Specificities read Abstract >>
                       Salvatore Bianco, Post Marketing Trial Manager - Servier Italia Spa 

12:40 - 13:00    Q&A 

13:00 - 14:20    Networking Lunch and Demo Area

14:20 - 14:50    Business options to leverage Oracle solutions for Life Sciences in Phase IV trials. 
                       Affiliate perspective   read Abstract >>
                       Hervé Fouché, Sales Consultant - Oracle HealthSciences Business Unit

14:50 - 15:10    Outsourcing to CRO: identifying the drivers for a best fit with study 
                       requirements read Abstract >>
                       Lidia Cappellina, Head of Outsourcing Management - Chiesi Group

15:10 - 15:40    Phase IV and observational studies: 
                       Pharmacovigilance requirements and quality control read Abstract >>
                       Gianfranco De Carli, Consulente Farmacoepidemiologia

15:40 - 16:10    Coffee Break

16:10 - 16:40    Phase IV studies using an eCRF system: how to minimize training costs 
                       using an e-learning systems     read Abstract >>
                       Silvia Gabanti - IT Manager - Arithmos Information Technology

16:40 - 17:10    How disclose the results of observational and phase IV studies    read Abstract >>
                       Andrea Rossi, Medical Writer - Eli Lilly

17:10 - 17:30    Q&A and Closure

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