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PUBLICATIONS

European Pharmaceutical Contractor

epc
Summer 2008
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
Adam Cohen at CHDR discusses the survival of the pharmaceutical industry, drawing on the fate of the dinosaurs for a solution to the increasing numbers of organisations becoming extinct due to a reluctance to adapt to their ever-changing surroundings.  
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Implementing new technology is invariably a challenge; Charlie Dean of PA Consulting highlights the negative consequences of taking products at face value without considering how they can really benefit your company.  
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Rapid patient recruitment and cost containment are just two of the factors leading industry and US Government sponsors to view non-traditional regions such as Eastern Europe as preferred locations for pharmaceutical research, claims Paul Wathall of HCA International Ltd.  
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Legal & Regulatory
Ethics is as inherent in conducting clinical trials as it is in medicine itself.Gabriela Mergentalova of MSOURCE Medical Development BV looks at how guidelines can be put in place in order to ensure that the appropriate ethical issues are considered and that safety therefore remains the top priority.  
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Andrzej Zylicz of ComplianceControl considers how, with the expansion of the EU, pharmaceutical life science companies from countries such as Cyprus, Estonia and Poland will face the increasingly complex challenge of developing and implementing compliant solutions that meet EU regulatory requirements.  
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The Food and Drug Administration Amendments Act of 2007 is arguably the most comprehensive regulatory change to affect pharmaceutical and biotech companies in recent years, and is likely to significantly change how the industry operates. Jeffrey J Stoddard and Edgar H Adams at Covance Periapproval Services consider how to exploit its potential whilst remaining aware of the risks involved.  
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Clinical Development
Robert Modre-Osprian and Günter Schreier at Austrian Research Centers GmbH assess the functionality of mobile phones as a means for physicians to track a patient’s personal health status almost irrespective of time and place, helping to increase compliance and reduce challenges for data clearance.  
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Clinical trial stakeholders are surrounded by data across various desktop spreadsheets, clinical trial management systems and interactive voice response systems; Jaime Cohen of BBK Worldwide investigates in relation to the drive for a patient recruitment strategy.  
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Liz Moench of MediciGlobal Inc looks at the developing impetus behind paediatric clinical research, purporting that because children are more vulnerable than adults, a sensitive, well thought out approach to patient retention programmes can make a significant contribution to the success of a trial.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Keith Wesnes of Cognitive Drug Research (CDR) examines some of the key issues facing the development of cognition enhancers, looking at the benefits they can have for a variety of mental attributes.  
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With the development of flow cytometry, central laboratories will most likely be more in demand than ever before. Carol Rosenthal at ICON Central Laboratories and Michael Rosenzweig at Tolerx analyse the details of a technology transfer related to a later phase clinical trial with a view to relocating cytometric assays from the bench.  
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LABS & Logistics
Chemical indicators are not supported by regulatory or standards-based guidance for GCCMP and are therefore not appropriate for use in the pharmaceutical industry; electronic temperature indicators should be considered as the most suitable alternative, claims Henry Ames of Sensitech  
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Natasha Molnár at SCA Cool Logistics contends that it is necessary to consider the sustainability of each individual component of the supply chain in order to improve your efficiency and fully understand the carbon footprint of your temperature-sensitive products  
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The developments in pharmaceutical labels since the 1930s have been significant, with constant improvements in functionality, versatility and security. Sascha Sonnenberg at Faubel charts the progress made, looking at what the future holds for this sector  
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DATA MANAGEMENT
Maximising efficiency and achieving effective long-term cost savings is crucial to ensuring a successful clinical research platform. Dave J Laky of eRT explores the benefits of introducing standards into the clinical research arena, which can positively affect patient safety through more efficient data analysis  
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The regulatory requirements of electronic submissions, and in particular the electronic common technical document, are rapidly changing; Amanda Keller at Octagon Research Solutions Limited outlines how these developments can improve your chances of meeting agency regulations, as well as optimising operational efficiency.  
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The pharmaceutical industry has seen a dramatic increase in the number of clinical trials conducted worldwide, which has led many sponsors to rely heavily on the use of electronic data capture (EDC) management and reporting tools to streamline clinical processes.Donna Wooten at Medidata Solutions, Inc, analyses the use of such methods  
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Sarah Powell at Thomson Scientific argues that organisations must be familiar with the needs of a project before embarking on an eCTD transition plan, and must understand its potential impact on existing standards, processes, resources and technology in order to help avoid common mistakes.  
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ECG CORE LABS & CARDIAC SAFETY
Continuing an investigation into drug-induced vascular thrombosis, myocardial ischemia and infarction, Boaz Mendzelevski at Cardiac Safety Consultants Ltd, explains that due to increased regulatory and public attention, drug manufacturers can no longer ignore the risks involved  
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Dr Wolfgang Timmer of CRS examines the conduct of thorough QTc trials in practice from a Phase I CRO’s perspective, arguing that there should be a standard form in order to maintain equality, reduce the time to market and speed development from Phase I  
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