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European Pharmaceutical Contractor

epc
Spring 2007
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in the current issue of EPC
   
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Marketplace & Business
In reiterating the value of a positive outsourcing bond between end-user and supplier, Mark Kobayashi-Hillary at the National Outsourcing Association examines an issue Not to be Ignored: Data Security in Outsourcing  
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Government initiatives to reward companies carrying out R&D can result in a reduced tax bill, greater post-tax profits and higher earnings per share. David Cobb, John Moore and Rosie Smith at Deloitte examine these benefits in Fully Functional R&D?  
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In Pharma Queues Up for QPs, Paul Thomas at Penn Pharmaceutical Services observes the growing demand for qualified persons since the implementation of the EU Clinical Trials Directive in 2004  
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As a critical part of the constantly evolving pharma landscape, Claudia Heinen of BearingPoint examines the complexity of integrating companies and stresses the importance of Demystifying M&A  
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Clinical Development
To satisfy increased regulations and appease consumer anxiety, Deborah Gold of WCI Consulting Ltd predicts a new, proactive pharmacovigilance environment, in Drug Safety Grows Up  
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It is the goal of the German regulatory authorities to have all pharmaceutical firms participating in the Electronic Exchange of safety messages. Dr Barbara Sickmüller of the German Pharmaceutical Industry Association and Gloria Cenni of Bassilichi Spa investigate  
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In Spirit of South Africa, Frans van Wyk and Paul Hunt at Pharm-Olam consider the enhanced reputation of this diverse country within the medical research arena  
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Offering a higher recruitment rate when compared to Western Europe or the US, it is no surprise that, increasingly, CROs Identify New Depths to Europe. Jennifer Felenda and Jörn Gatermann of Gatermann Clinical Research Consulting assess this research-centric hotspot  
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Clinical Laboratories & Logistics
Today it is possible to outsource almost any activity connected with drug development. EPC’s editor Dr Graham Hughes examines the latest trends in The Global Market for Central Clinical Laboratories  
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The multiple requirements of the pharmaceutical industry necessitate an enterprise-wide solution with limitless capabilities.Madhavan Kayambu of HCL Technologies looks at laboratory management systems, in No LIMits  
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The biopharmaceutical cold chain plays an increasingly critical role in global pharmaceutical and biotherapeutic development processes. Jeff Clark of BioStorage Technologies, Inc and Rolf Lucht of Globex24 emphasise The Importance of Integrity  
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In Safeguarding Shipments, transportation innovations come under consideration as the movement of temperature-sensitive materials by air warrants a degree of caution, notes Martin Peter at Envirotainer  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Lately, the indiscriminate use of antibiotics has led to severe public health issues, with harmful micro-organisms becoming resistant to available treatments. Sylvia Miriyam Findlay of Frost & Sullivan highlights Antibiotics Under Attack  
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In Easy to Swallow, Paul Martin of Nautilus Biotech reports on recent developments in oral drug delivery of therapeutic proteins  
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A thorough QT/QTc study can be prevented by oncology drug toxicity. This complex drug development problem is addressed by William Wheeler at Spacelabs, in Weathering the Perfect Storm  
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Dermatology has developed its own unique position within both medicine and clinical trials. Theresa Callaghan of proDERM sheds light on Mysterious Skin, examining recent therapeutic advances  
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Data Management & IT Solutions
Paul Frost at Oxford Pharmaceutical Sciences scrutinises external data standards within the pharmaceutical sector and discovers that, as a result of the FDA’s study data tabulation model, pharma is Migrating to CDISC  
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From paper to electronic submissions, Shylendra Kumar of Datafarm Inc asks, eCTD: Will You Be Ready for 2009?  
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Whilst EDC may have impeded industry efforts to create a unified clinical trial process, an eClinical platform can help achieve harmony. David Laky at eResearchTechnology predicts technological developments in The Evolution of EDC into eClinical  
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Nancy Smerkanich of Octagon Research Solutions embarks on a Journey to the Centre of eCTD, charting the advances made in electronic submission and calling for a convergence of standards within the regulatory arena  
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June Dean of ITESOFT discusses key steps in mapping and automating corporate information flows, Post Perfect – Mastering the Digital Mailroom  
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Commercial & Regulatory
To fulfil increasing demand from the European Medicines Agency for electronic registration submission, Simon Andriesen at MediLingua BV discusses the implications of translating text stored in content management systems and asks, XML: A Translator’s Nightmare?  
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Whilst blockbuster drugs grab headlines, it is the technologies used to identify these high-revenue pharmaceuticals that are more important in the long term. When it comes to pharmaceutical innovation, Peter Steele of Thomson acknowledges that Diversification Delivers  
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In V Model for Victory, Charlie Dean and Hein Smit Sibinga of PA Consulting argue that the key to success can be found in adhering to a compliant process development framework  
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Elisabethann Wright and Susan Clements at Hogan and Hartson examine changing trends in pharmaceutical development following a new paediatric medicines regulation, in Children: Seen and Treated  
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Recognising that the next generation of process efficiencies within the life sciences industry will come from the implementation of harmonised data standards, Sarah Powell of Liquent asks, XML: The Language of Success?  
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In Paperless Platforms, Kate Trainor at Perceptive Informatics, Inc addresses the emerging eClinical enterprise  
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