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  Events - October 2012


Spanish ePharma Day 2012

25 Oct 2012 - 25 Oct 2012 - Madrid, Spain



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The ePharma Day is pleased to present its 4th Annual Meeting:

Traceability in Clinical Trials: from Study Design to Submission

Thursday, October 25th 2012
TRYP Madrid Ambassador Hotel
Cuesta de Santo Domingo, 5
Madrid, SPAIN
10:00 – 17:40

What You'll Learn:
•    Traceability: what does it mean and why is it important?
•    How do the rules and responsibilities in  e-clinical trials differ to paper based studies?
•    How should researchers handle e-source documents?
•    Aspects of the e-Common Technical Document (e-CTD): European Situation and local status
•    Strategies for e-Trial Master file creation and maintenance
•    Integrating Electronic Data Capture (EDC) with other clinical systems
•    The importance of CDISC in traceability
•    EudraCT/OssC (ITA only)
•    Strategies for e-management of pharmacovigilance (Eudravigilance)-xml
•    Technologies and methodologies that drive standards and traceability

Target audience:
We welcome delegates from Pharmaceutical and Biotechnology companies, Clinical Research Organisations, Academic Centres, Hospital Centres, and Clinical Technology companies in the following disciplines: Clinical Research and Development, Quality Assurance (CSV) Unit, Pharmacovigilance, Clinical Operations, Statistics and Data Management, Epidemiology, Information Technology.



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