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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
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Thursday,
April 26th 2012
ORACLE Deutschland B.V & Co. KG
Robert-Bosch-Strasse 5
63303 Dreieich - Frankfurt
10.00 – 18:10 |
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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?
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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.
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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
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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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