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  Events - October 2012


UK ePharma Day 2012

31 Oct 2012 - 31 Oct 2012 - London, UK



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

Traceability in Clinical Trials: from Study Design to Submission

Wednesday, October 31st 2012
Royal Society of Chemistry
Burlington House, Piccadilly, London, UK
09:00 – 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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BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
Treatment of Common Prostate Cancer
Researchers at UTSW have found that the prostate cancer treatments suppress immune response and may promote relapse.
Cancer Drug Could Treat Blood Vessel Deformities
A drug currently being trialled in cancer patients could also be used to treat an often incurable condition that can cause painful blood vessel overgrowths inside the skin.
Structure of Crucial Enzyme Identified
Researchers at UTSW have determined the atomic structure of an enzyme that plays an essential role in cell division and better treatment of cancer.
New Immunotherapy Trial for Type 1 Diabetes
The search for a treatment for Type 1 diabetes (T1D) - which affects over 400,000 people in the UK – will be stepped up with the start of a new phase one clinical trial at Guy’s Hospital in London.
Recruitment of First Patient in Clinical Study
Company has announced recruitment of first patient in clinical study assessing Visco-ease with Beatson Cancer Centre for the treatment of RIX.
Fighting Prostate Cancer
Identifying the most promising compounds which can be used as medications for prostate cancer.
Chi-Med Initiates Sulfatinib Phase III Registration Study
Company has initiated SANET-p, a Phase III registration trial of sulfatinib with pancreatic neuroendocrine tumors (“NETs”).
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