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European Pharmaceutical Contractor

epc
Summer 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
With a growing number of potential new drugs entering clinical development, the competition for qualified patients is intensifying. Joshua Schultz at PAREXEL International tackles the challenge of finding New Recruits  
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Maximise Your Monitor for success within the clinical research arena. Focusing on role transformation and optimisation as a means of achieving long-term business advantages, Anick Duchesne of Pfizer offers her advice  
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Whilst involving newborns and children in clinical trials is a challenge to overcome, clinical research in paediatric populations is continuing to grow each year. Ronald Keeney, Stephen Petrycki and Alexandar Cvetkovich Muntanola at INC Research examine how to maximise study performance, whilst ensuring safety, in Early Learning  
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As an environment for industry-sponsored clinical research, Australia is blossoming – Alek Safarian of Novotech recognises that outsourcing services in drug development are On the Up Down Under  
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Global Clinical Trials put a Strain on Communications argues Mark P Wade at Lionbridge Technologies. As clinical trials push back global boundaries into the markets of Eastern Europe, Asia and Latin America, good translation should be high on the list of priorities  
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Legal & Regulatory
Fast, easy access to managed and monitored information greatly assists regulatory compliance; however, the activities and strategies designed to achieve this demand serious funding. Carl Turner of Compliance Control suggests some solutions, in Cost-Managed Compliance  
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In Navigating the Regulatory Landscape, Sarah Powell at Thomson Scientific investigates the plethora of information that must be managed and understood within a life science organisation  
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Submission strategies in the EU call for stringent attention in order to ascertain the appropriate legal authorisation. Dr Jan van der Weide of Pharmalink Consulting asks, are you Ready to Submit?  
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Jeffrey Stoddard, Edgar Adams, Zdravko Vassilev and Paige Chavers at Covance consider the practicalities of implementing FDA and EMEA risk management guidelines, in Failure to Warn is No Longer an Option  
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An unforeseen event during drug development or distribution can affect end product quality, with potentially serious consequences for all concerned should it reach the marketplace. Philip Payne at RSSL Pharma raises Contamination Concerns  
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Clinical Development
With its increasingly positive reputation within the pharmaceutical industry, Crispin Kirkman of ETNA Ltd regards India as a potential clinical trial hotspot, in The Jewel in the Crown?  
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First Time in Human Studies: TeGenero One Year On; Richard Huckle at Constella outlines the implications for drug development post-Northwick, focusing on the recently revised EMEA/CHMP guidelines  
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Dr Georg A Mathis of Appletree Ltd believes successful project leaders must have the ability to supervise people in a complex environment, and asks how can management achieve Power over the People?  
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Oriana Zerbini of CROM Srl talks to EPC about the role of CROs within the evolving pharmaceutical marketplace, in The CRO Story  
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The increasing pressure to bring the safety risk management processes of pharmacovigilance into earlier phases of development is noted by Dr Mark Perrott of WCI Consulting Ltd. He advises Developing Holistic Safety Risk Management strategies to guarantee a safer environment for drug development  
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Clinical Laboratories & Logistics
Adrian Possumato of Multisorb Technologies champions sorbents as a means to calculate successful packaging formulations, in The Rules of Absorption  
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With the global expansion of CROs, laboratories are asked to perform more complex and expensive methods to validate new assays. Dr Hermann Schulz of INTERLAB central lab services focuses on this market development with regards to Central Labs: Types, Distribution and Capabilities  
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Airfreight and Pharma: A Common Goal? Serge Alezier of Air France Cargo-KLM Cargo reports on the stakes of the pharmaceutical industry in the field of air transportation  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Melvyn Little at Affimed Therapeutics heralds the development of monoclonal antibodies as Next Generation Antibody Treatments – providing a valuable discovery platform within cancer therapeutics  
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Multifunctional sterile facilities are essential for the development of safe and investigational products; John Seagrief at R5 Pharmaceuticals urges us to Keep It Clean  
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Simon Bennett and Charles Potter at Glide Pharma review a number of solutions to the problems posed by injection vaccines, predicting a Solid Future for Needle-Free Vaccine Delivery  
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To truly understand the basis of cancer, says Dr Stephen Little at DxS Ltd,we must examine changes and potential problems at a genetic level. Molecular Tests, Targets and Therapies for Cancer foresee a new dawn in cancer treatment  
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As the number of lyophilised drug products on the market increases, Graham Reynolds at West Pharmaceutical Services, Inc addresses the need for systems and devices to administer these drugs, in Reconstitutional Affairs  
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In a bid to Breathe Freely, Sriram V at Frost & Sullivan tackles the challenges associated with the development and delivery of asthma therapeutics  
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As flow cytometry enters the realm of drug discovery and development, Ken J Pennline at Esoterix Clinical Trial Services discusses this technology platform’s potential, in Marked Out: Identifying Biomarkers with Flow Cytometry  
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Data Management & IT Solutions
Sheila Kelly at ICON Clinical Research extols the virtues of Symmetrical Data Management for practical use within the pharmaceutical industry  
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The transition from paper to electronic records renders the safety of data vulnerable. Donn Mukensnable at Convergence CT proffers a warning, in Medical Data Sharing: The Value is in the Details  
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In today’s highly regulated world, compliance is one of the most pressing issues that life science companies must address. Liz Verchase at Qumas shares her views and raises the question, is EDC – The Comprehensive Compliance Solution?  
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Pharmaceutical professionals work with an overwhelming amount of information. Helena Korjonen-Close at the Institute of Clinical Research explains how to avoid drowning in data by Managing Your Information Overload  
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