Spanish ePharma Day 2012
25 Oct 2012 - 25 Oct 2012 - Madrid, Spain
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
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
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.