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 4th Annual Meeting:

Traceability in Clinical Trials: from Study Design to Submission

Thursday, April 19th 2012
Hotel Melià - Milan

Via Masaccio, 19
09.30 – 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. 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?
•    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

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

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


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