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European Pharmaceutical Contractor

epc
Autumn 2006
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
Faced with the saturation of most pharma markets, Dr Michèle Piotte of Cato Research and Alexandre Prokhoroff contend that a proper assessment of how recent trends might influence the pharma business model is needed, in Outsourcing: The Next Generation  
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In the 1990s, the pharma industry’s emphasis was on regulatory submissions and controlled documents such as SOPs. Boyd Robinson of BearingPoint’s Life Sciences Practice observes the shift towards consolidated digital content, inA United Front  
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Taking the Danger Out of Risk – Hein Smit Sibinga of PA Consulting Group puts risk based programme management through its paces  
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Wouldn’t we all rather be in control of the dangers facing our business? Keith Gallois and Gerry Heffernan of Chubb Insurance provide some Critical Coverage  
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Set against a background of rigorous compliance requirements, companies face the dual pressures of bringing new products to market, whilst engaging in careful cost reduction. Hence, Keeping Tabs On Data Management has never been more important, concludes Sameer Jain of HCL Technologies  
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Legal & Regulatory
In The Entitlement Dispute, Neil Coulson of Jones Day looks at the current position on entitlement to a patent, and explores the factors that will now be taken into account  
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Following recent rulings, Nicholas Jones of Withers & Rogers reports on exemptions that may be available to pharmaceutical manufacturers within Europe and beyond, in the Search for Absolution  
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MHRA Ensures Quality Standards of Traditional Herbal Medicines – following Directive 2004/24/EC, the MHRA’s Richard Woodfield explains the implementation process in the UK, and considers the path to harmonisation across the EU  
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In a complementary piece, Dr Jung Wing Wan of Pharmalink Consulting Ltd reflects on the development of regulations in Europe and beyond, in Herbal Medicinal Products: The Need for Regulation  
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Manufacturers of medicinal products are now legally required to have their patient information leaflets checked in order to get their products approved. In Readability Testing of PILs – A New ‘Must’, Simon Andriesen of MediLingua reviews the safeguards in place  
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Clinical Development
The Recurrent Recruitment Nightmare has been known to ruin a good night’s sleep. Thankfully, Maggie Smith of P(i) Patient interaction is on hand to explain how to attain the results you need  
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Kathleen Drennan and Beth Koch of Iris Global Clinical Trial Solutions unravel a series of unique challenges when seeking participation in autism spectrum disorder (ASD) research, in Paediatric Developmental Disabilities – Getting Research Right  
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The design of ‘not-so-thorough’ QT/QTc studies calls for substantial attention to the electrocardiographic component. In Proof Negative, Marek Malik of St Paul’s Cardiac Electrophysiology, London, puts forward a detailed strategy for accurate monitoring  
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As the traditional view on IT and process control solutions has widened,Walfried Laibacher of Honeywell Building Solutions sees best practice principles bringing a competitive edge to business, whilst guaranteeing product quality, in Manufacturing Demystified  
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With some single trials requiring up to 60 centres to meet EU standards of efficacy and safety, European developers are looking beyond their comfort zone to recruit patients and run trials. Never has the time been better for Clinical Trials on the Bloc, conclude Klemens Schuette and Branka Duvnjak of ERGOMED  
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Clinical Laboratories & Logistics
PiE in the Sky? Last month the EMEA published guidelines on pharmaceuticals in the environment, calling for a robust environmental risk assessment to be submitted with every new marketing authorisation application. David Cocker of Ecotrac NV calculates the long-term impact for pharma  
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Mathieu Bordier of Cryo Express calls on CROs to re-examine the scope of services on offer within the cool chain logistics of clinical trials, in Home and Dry  
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Integrity Matters – securing safe transit of temperature-sensitive cargo can be a stressful process argues Frank Mauler of Panalpina, but scratch the surface and high value, good quality transport methods do exist  
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Defined by the US Pharmacopoeia, the mean kinetic temperature requirement firmly invests pharmaceutical storage facilities with much responsibility. Bradley Smith at Colt International Ltd outlines the importance of product quality, in Keeping it On the MKT  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
In Absolute Bioavailability: The Complete Picture, Graham Lappin and R Colin Garner of Xceleron identify the scientific benefits of a study method once perceived as lacking the cost benefit to warrant its implementation  
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Clive Wilson at the Department of Pharmaceutical Sciences, Strathclyde Institute for Biomedical Sciences and Neena Washington, a Consultant Senior Scientist, seek to maximise drug therapies by synchronising with the human body clock, in Comprehending Chronotherapeutics  
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In oncology therapeutics, diseases are categorised by organ pathology, but today a shift towards a genetic or metabolic pathway-based taxonomy of disease is palpable. Remaining Unphased by MTTs is the order of the day, assures Connie Wierman of INC Research  
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Johan HC Reiber of Leiden University Medical Center,George Heyrich of St Mary’s Medical Center, and Anton van Weert of Bio-Imaging Technologies, explain how valuable a tool quantitative coronary angiography in clinical studies can be, in A Period of Refinement  
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With CNS disorders representing around one-third of the disease burden across the major pharmaceutical markets in Europe, Sumanth Kambhammettu of Frost & Sullivan mulls over future trends, in Room at the Inn  
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Data Management & IT Solutions
The task of adopting CDISC standards may be an enormous one for the pharma industry, but achieving Complete Compliance brings benefits equivalent to the effort exerted, argue Kristof Schellis and Joris De Bondt of SGS Life Science Services  
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What Keeps Regulatory Professionals Up at Night? Jim Nichols at Liquent, Thomson Scientific, identifies the best way to register pharmaceutical products and ensure market penetration  
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Faced with the consequences of failing to comply with a litany of regulations, and swallowing the financial implications of missing submission deadlines, Dr Gareth Williams of Octagon Research Solutions looks at clever ways of Taming the eCTD  
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STAFF RECRUITMENT & TRAINING
In Training Days, Steve Pinder of MDS Pharma Services asks readers to think carefully about their training strategies, and to remember that coaching should not be restricted to the playing field  
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As the outsourcing scene expands, one area of flexible resourcing is attracting little attention but enjoying dramatic growth. Keith Hobson of RSA charts The Rise and Rise of the Interim Executive  
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Armed with a new report, Jo Causon of the Chartered Management Institute presents the case for organisational productivity across the pharmaceutical industry, in Inwardly Mobile  
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In the light of serious difficulties posed by the new TUPE regulations, Nicola Walker of Hogan & Hartson ponders whether A Problem Solved is a Problem Outsourced?  
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