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  Events - October 2012

Spanish ePharma Day 2012

25 Oct 2012 - 25 Oct 2012 - Madrid, Spain

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The ePharma Day is pleased to present its 4th Annual Meeting:

Traceability in Clinical Trials: from Study Design to Submission

Thursday, October 25th 2012
TRYP Madrid Ambassador Hotel
Cuesta de Santo Domingo, 5
Madrid, SPAIN
10:00 – 17:40

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.

Further information
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First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
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