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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 19th 2012
Hotel Melià - Milan
Via Masaccio, 19
09.30 – 17:30 |
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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.
Paolo Morelli, CEO of CROS NT
Group 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
• 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:
Italian
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Oracle Health Sciences, CROS NT and CD Pharma
are pleased to invite you to an exclusive VIP
dinner on:
Wednesday, April 18th - 21:00
AlaCena – Via Masaccio, 19 – Milan
The dinner will provide an opportunity for you
to network informally with your industry peers
and discuss sponsors’ products and strategic
development plans. The restaurant offers
a Mediterranean cuisine and typical Spanish
dishes in a cosy environment with close
attention
to every last detail.
Please confirm your interest on the
registration form
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Hotel Reservation
Service:
If you need an hotel for overnight stay on April 18th, we
provide a reservation service: 4 stars hotel, 130 euro,
with free private shuttle in the morning to the Melia hotel,
conference venue, and return to the hotel the evening before for
those who wish to attend the "Exclusive VIP Dinner."
Please apply to this service directly on
the
registration form --------------------------------------------------------------------------------------------------------------------------------------------------------------------
VERSIONE ITALIANA
HOW
TO SPONSOR >>
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