Data Safety Monitoring Board:
Operational strategies in planning and managing Data Monitoring Committees


Tuesday, 12th  April 2011

Hotel Melià - Milano

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

The event will cover the process  optimisation in ensuring the safety of clinical trail's participants, issues and hot tips in delivering valid data for analysis; description of statistical methods to support DSMB decisions and its role for the appropriate termination of clinical studies when significant benefits of risks have been uncovered.

Speeches will include:

§ The role of DSMB in clinical research
§ When a DSMB is required
§ DSMB Constitution
§ SOP needed to be in place for DSMB analysis
§ Content of a DSMB Charter
§ DSMB and Sponsor Responsibilities
§ Legal and ethical consideration
§ Statistical stopping rules
§ Using an independent statistician to support a DSMB
 

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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