Optimizing Value and Quality in Clinical Data
with Standards and Data Integration


Donnerstag 5. Mai 2011

Max-Planck-Institut für Biochemie
Am Klopferspitz 18
D-82152 Martinsried

München

10:00 – 17:30

Facing pipeline difficulties, increasing costs and timeline pressures, more biopharmaceutical companies are using standards and moving to integrated systems to allow better and faster decisions.
The event will focus on the implementation of effective strategies for improving quality of data, on the evaluations on computerized systems and on the usage of  well recognised standards.

Topics covered:

- Strategic benefits of integrating clinical data across all trials
- Data Integration and translational research
- Development of Data Standards and Data Integration tools
- Integrating Clinical Data Management Systems, Clinical Trial Management
  Systems, EDC, Pharmacovigilance Systems, Drug Supply Management
  Systems, and IVRS
- Life sciences Data Hub
- CDISC Standards
- e-Submissions and interactions with health authorities
- Integration with heterogeneous health information system s within a hospital
  or region to exchange information via standardized messages.


WER SOLLTE TEILNEHMEN
Pharmazeutische Unternehmen: Medical Director, Medical Affairs Director, Medical Informatics, R&D Manager, Pharmacovigilance Operation Manager, Clinical Manager, Clinical Research Associate, Clinical Project Manager/Clinical Project Leader, Statistiker und Data Manager Univerisitäre 
Biotechnologie Unternehmen: Managing Director, Chief Medical Officer.
Forschungseinrichtungen/Universitäten: Managing Director, Principal Investigator
CRO: Managing Director, Business Development, Medical Director, Project Manager, Clinical Research Associate

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