Sponsored by:


 


 








under the Patronage of:



 


Media Partner:



 

The ePharma Day is an initiative that aims to create a series of events dealing with the most relevant issues concerning clinical trials. 

 The ePharma Day is pleased to present its 2th 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 – 17:30

ePharma Day 2012 will allow delegates to learn more about data traceability in clinical trials and safety - from trial design to authority submission encompassing trial design, patient data acquisition, trial monitoring, safety cases management and signal detection. Fernando Martinez, Vice President Business Development, PharmaNet/i3 will share best practices, results and experiences in this field.

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
•    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.

Official language: Spanish and English


Oracle Health Sciences and CROS NT
are pleased to invite you to an exclusive VIP dinner on:
Wednesday, October 24th  -  09:30 pm
Espazo Enxebre - Calle Hileras, 4 - Madrid
The dinner will provide an opportunity for you to network informally with your industry peers
and discuss sponsors’ products and strategic development plans.

 

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