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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 4th Annual Meeting:

Traceability in Clinical Trials: from Study Design to Submission


Thursday, April 26th 2012
ORACLE Deutschland B.V & Co. KG
Robert-Bosch-Strasse 5
63303 Dreieich - Frankfurt

10.00 – 18:10

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. Robert Hermann, Managing Director, cr.appliance and Martin Scott, Director, Numerus Ltd., 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
•    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.

Oracle Health Sciences and CROS NT
are pleased to invite you to an exclusive VIP dinner on:
Wednesday 25 April  - 19:00
Exenberger Restaurant
Bruchstraße 14 / Ecke Textorstraße 60594 Frankfurt/Main

The dinner will provide an opportunity for you to network informally with your industry peers
and discuss sponsors’ products and strategic development plans.
"Exenberger" is one of the finest modern restaurant in Frankfurt. The quality of the food is a must, presented in a pleasant atmosphere and special place, “Klassikstadt”: historic cars, expression of craftsmanship and technical perfection of past years.
Please confirm your interest on the registration form






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