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home > epc > Spring 2003
PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2003
   
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introduction
Departing EPC Editor Dr Graham Hughes bids a fond farewell to the journal and introduces his successor, Julia Lloyd-Parks, in a joint Editors' Letter  
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Marketplace & Business
In The CRO Scene in 2002/3, Dr Graham Hughes, Scientific Investment Manager at Technomark Medical Ventures, concludes that the growing CRO industry is still a healthy investment  
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The clinical research function is largely seen as a cost centre. In Organisation and Culture in Drug Development - Do We Need to Change the Mindset?, Les Rose, Managing Director of Pharmavision Consulting Ltd, considers the cost-effectiveness of getting profitable drugs to market  
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Mark Dolphin, General Manager of Datastream Systems, explains how asset management tools can reduce production risk, in IT Solutions for the Asset Management Challenge  
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The pharma industry faces a continuing challenge to employ the right staff. In Finding the Best People: The New Pharma Challenge, Dr Faiz Kermani, Linda White and Pietro Bonacossa, at Chiltern International, address this issue  
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In Trademarks in Russia - A Fight Against Counterfeiting and Unfair Competition, Elena Solovyova, Partner in the intellectual property law firm 'A.R.S.-Patent', discusses trademark misuse  
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Clinical Trials
Dr Stephen Little, CEO of DxS Ltd, investigates the increasing demand for genetic analysis in clinical trials, in How to Include Genetic Analysis in Clinical Trials  
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n 2000 the 52nd World Medical Association General Assembly adopted the sixth version of the Declaration of Helsinki. Dr Delon Human, Secretary General of the World Medical Association, analyses the changes made, in The Declaration of Helsinki  
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In Clinical Trials in Children: A Challenging Need, Dr Carlo Giaquinto, Department of Paediatrics at the University of Padova, Italy, explains the difficulties of conducting paediatric clinical trials  
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Dr Borislav Borissov, Executive Director of the Bulgarian Drug Agency, comments that research costs and long approval times have placed a renewed emphasis on the design of clinical trials, in Alternative Statistical Methods for Conducting Clinical Trials - A Personal Regulatory Insight  
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Legal & Regulatory
Trevor Cook, Intellectual Property Specialist at Bird & Bird, warns of patent protection problems, in Tailoring Patent Laws to Meet the Real Needs of Pharmaceutical and Biotechnology Research  
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In July 2001, the European Commission presented its proposal for a reform of EC pharmaceutical legislation. Dr Manja Epping, Lawyer at Ashurst Morris Crisp, highlights the implications, in Part One of Data Exclusivity Under Review - Striking the Balance Between Originator and Generic Medicines  
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In The Other Side of 21 CFR Part 11: There is More to it than Technology, Irina Colligon, Senior Consultant at Barnett International, comments that even as systems tailored to Part 11 are being introduced, there is still no industry-wide consensus  
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Drug Discovery, Development & Delivery
The challenge of cost-effective outsourcing is analysed by Geoff Tomlinson, Principal and Harald Geimer, Director of PRTM, in The Four Dimensions of Outsourcing Excellence  
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In Targeting Drugs to the Nervous System, Fran Crawford, Research & Development Director at SynGenix Limited, investigates three methods of anatomically targeting drugs  
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Dr David Huckle, Chief Executive of Adams Business Associates, explores major advances in molecular diagnostics, in The Changing Face of Diagnostics and its Impact on the Pharmaceutical Industry - An Update  
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e-Data
Neil Konopka, Head of Quality & Regulatory Compliance at Phase Forward Inc, comments on developing EDC archiving procedures, in Archiving EDC Data: Further Challenges for Compliance  
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The new NHS initiative - Delivering 21st Century IT Support for the NHS - will provide the structure and support for a brave new world. Dr Ian Howells, Vice President Marketing EMEA at SeeBeyond, explains Why the NHS Needs Integration  
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In Web-Based Resource Management Tools for Clinical Trials - Can a Technology-Enabled Platform Facilitate Acquisition of Resources?, Rod Saponjic and Scott Freedman, monitorforhire.com, suggest web technology for identifying CRAs to fulfil clinical development projects  
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Science & Innovation
The Alzheimer's disease market is an attractive investment with huge unmet need. Ben Greener, Neurology Analyst at Datamonitor, examines Alzheimer's Disease: What will the Future Hold?  
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In Strategies for Biocompatibility Testing of Medical Devices, Dr Lise Bollen, Head of Medical Device Biocompatibility Testing at Scantox AS, discusses hazards associated with medical devices  
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Risk Management
In Clinical Research and Data Privacy: A Comparison of US and European Approaches and Philosophies, Dr Thomas Bart, Managing Director of eCR e-Clinical Research GmbH, looks at the worldwide differences, depending on regional law, culture and tradition  
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Karen Harper, Partner at KPMG New York, and John Morris, Partner at KPMG London, examine new regulations on the privacy of medical information, in Privacy Compliance as Competitive Advantage  
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For a clinical project manager, risk assessment and risk management comes with the territory. Dirk Roels, Senior International Project Manager at Medisearch International, provides an insight, in Common Risks in Clinical Project Management: A Project Manager's Perspective  
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Finnish Focus
In BioneXt Tampere 2003-2010, Matti Eskola, Managing Director of Finn-Medi Research Ltd, outlines this programme which focuses on improving biotechnology in Finland  
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N Tapani Saarinen, Vice-President Business Development, Turku Science Park Ltd, highlights the benefits of a unique mixture of science and business, in PharmaCluster Finland - A Unique Network  
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Global Central Laboratories
Dr Howard M Hill, Director of Pharmaceutical Analytical Services at Centralabs, explains how the validation of analytical methods can enable assay monitoring and asks, Is your Data Fit for its Purpose?  
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As use increases of e-clinical trial systems by the clinical trial industry, more and more interest is geared towards the integration of clinical laboratory values. Valdo Arnera MD, General Manager of PHT Corporation assesses this trend, in Central Lab Values in an EDC Environment  
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Previews & Reviews
A taste of what to expect at Cordia EuropaBio Convention 2003  
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Dr Graham Hughes, Scientific Director at Technomark Consulting Services, reports from the 7th EUFEPS Congress of Pharmaceutical Sciences, in The Pathway to New Safe Medicines  
   
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