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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
Country,
Date and Location:
ITALIAN ePHARMA DAY -
Thursday, 19th April
2012 - Milan
MORE
DETAILS >>
GERMAN
ePHARMA DAY -
Thursday, 26th April
2012 - Frankfurt
MORE
DETAILS >>
UK
ePHARMA DAY -
Wednesday, October
31st, 2012
- London
MORE DETAILS AVAILABLE SOON
RUSSIAN
ePHARMA DAY -
Thursday, 19th July
2012 - Moscow
MORE
DETAILS AVAILABLE SOON
SPANISH
ePHARMA DAY -
Thursday, 25th October
2012 - Madrid MORE
DETAILS AVAILABLE SOON
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.
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.
For any additional information, please contact:
Enrico Pedroni
Event Manager
Via Roma, 25 - 24022 Alzano Lombardo (BERGAMO) - ITALY
Tel. (+39) 035.515684 Mob. (+39) 338.8422561 Fax (+39)
035.4501262
enrico.pedroni@epharmaday.org
Skype: enrico.pedroni
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