Phase IV Trials and Observational Research: 
Operational strategies for convincing regulatory and commercial data

Tuesday, 20th  April 2010

Hotel Melià - Milano -
Via Masaccio, 19 - 20149 Milano.
09.30 – 17:30

Stop Press:  Keynote Speaker: Lesley Wise from MHRA. Title of speech: Requirements for risk management planning, and implementation of observational studies

Successful execution of any Phase IV study requires that the study processes be streamlined enough to meet the often rapid and commercially-dependent timelines, but rigorous enough to produce data that is rooted in good science and able to stand up to peer review. This balance is often difficult to maintain in the face of changing regulatory and commercial environments. 

In this event speakers will utilize case studies from recent Phase IV to explore what operational strategies worked with particular reference to electronic solution used (paper CRF, eCRF, ePRO, electronic registries), what was lacking, and how the CRO/Sponsor relationship was managed.

Who Should Attend:
Pharmaceutical Companies: Medical Director, Medical Affairs Director, Medical Informatics, R&D Manager, Pharmacovigilance Operation Manager, Clinical Manager, Clinical Research Associate, Clinical Project Manager/Clinical Project Leader, Statisticians and Data Managers.
Hospital Research Centre/University/Privates: Managing Director, Principal Investigator.
CRO: Managing Director, Business Development, Medical Director, Project Manager, Clinical Research Associate.
Biotech: Managing Director, Chief Medical Officer.




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