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European Pharmaceutical Contractor

epc
Autumn 2003
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 this issue of EPC
   
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introduction
Julia Lloyd-Parks reviews the articles featured in the Autumn issue

 
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Marketplace & Business
The pharmaceutical sales process is riddled with inefficiencies and the productivity of individual sales teams has fallen. Thomas Hennlich, Senior Manager, and Andrys Aardema, Consultant in Customer Relationship Management, at Deloitte Consulting, consider Changing the Approach to Selling Pharmaceuticals

 
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In Make or Buy? A Strategic Assessment of the Benefits of Outsourcing, Blair McCallum, Head of McKinsey & Company's Production System Design Centre (PSDC), advises manufacturers not to regard outsourcing as a panacea for every ill  
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Integrating e-business partnerships between regulatory authorities and industry will face initial difficulties. Dr Peter-Christoph Schulz, Safety Officer at Bayer Vital GmbH, suggests some solutions, in e-Business in Pharmacovigilance  
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Clinical Trials
In How are Research and Clinical Trials Governed? Jo Wilson, European Director of Marsh Healthcare Services, explains why proper control, regulation and governance are essential to ensure quality research and clinical trials in health and social care  
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The pharmaceutical industry is under enormous pressure to develop and produce novel therapies as quickly as possible. Nicky Dodsworth, Director of Quality Assurance at Pharm-Olam International (UK) Ltd, investigates the opportunities in Central and Eastern Europe: Quality and Quantity  
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In Recruiting HIV Infected Patients for Anti-Retroviral Clinical Trials in CEE and the Russian Federation, Stefan Comhaire, Project Manager at Medisearch International, outlines the mutual benefit for patients and the pharmaceutical industry  
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Patient recruitment remains one of the key challenges faced by the pharmaceutical industry today. Tom Ruane, Director of Patient Recruitment & Retention at Quintiles, considers Establishing the Patient Recruitment Algorithm - Should we Apply a more Heuristic Approach?  
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Pietro Bonacossa, Marketing Executive, and Dr Faiz Kermani, Budgets, Proposals and Marketing Executive at Chiltern International Inc, examine why patients do not fully comply with their treatments and how this problem can be addressed, in Driving Patient Compliance  
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Patient diaries constitute one of the most relevant sources of direct information in clinical research. In Patient Diaries: A Possible Source of Data Inconsistency?, Sebastian Pacios Merino, Vice President of Operations, Countries Group, PRA International, identifies the perils and pitfalls  
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Legal & Regulatory
Margaret Walters, Director of Pharmacovigilance at Merck Sharp & Dohme, helps us to navigate the difficult terrain of Pharmacovigilance in the EEA - An Overview of Requirements Impacting Industry  
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Customers are increasingly demanding instruments with Part 11-compliant software. Lynda J Bruce, Principal Engineer in the Life Sciences Business Unit and Annie LC Broadhurst, Technical Scholar at Cambridge Consultants Ltd, review Industry Trends in the Development and Provision of 21 CFR Part 11-Compatible Equipment  
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Clinical Trials: Asthma Focus
In Clinical Trials in Asthma, Dr Alan Davies, Therapeutic Director for Kendle International Inc, highlights the substantial financial and health rewards for those companies that can bring a novel product successfully to market  
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Clinical Trials Supplies
Bob Tilling, Director of New Business Development at MAP80 Systems Limited, keeps readers up-to-date, in How Clinical Trials Supplies Labelling May Be Affected by the Extended EU Local Language Requirements and How Integrated Labelling Systems Could Provide a Solution  
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Special Focus: Cleanrooms
In Maintaining a Spore-Free Environment in the Cleanroom, Suzanne Stubbs, Quality Manager at Shield Medicare Ltd, digests the strict requirements of EU good manufacturing practice for medicinal products  
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Drug Discovery, Development & Delivery
Dan Stevens, Marketing Manager, Life and Chemical Sciences at SGI, welcomes us to Visualisation in Drug Discovery: The Way of the Future  
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Traditionally restricted to treating the common cold and nasal allergies, nasal delivery is enjoying something of a renaissance. Per Gisle Djupesland, Head of R&D and Co-Founder of OptiNose AS, puts the question Who 'Nose' How Far Nasal Delivery Can Go?  
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e-Data
Dr Miklos L Schulz, President and Senior Consultant, and St Clare Chung, Director of Biostatistics and Data Management at SciAn Services Inc, tackle The Next Major Hurdle for Electronic Data Capture: To Embrace Paper  
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Both pharmaceutical companies and CROs are keen to invest in electronic technology. Dr Uwe Albrecht, Managing Director of Mediconomics GmbH and CEO of Mediconomics Inc, analyses the benefits of Electronic Tools for Drug Development and Registration from a CRO's Perspective  
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Science & Innovation: Cancer Focus
Gijsbertus J Pronk PhD, Senior Director, US Business Development at Atugen AG, identifies New Approaches to Developing Cancer Drugs  
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In Improving Cancer Diagnosis and Prognosis Procedures, Dr Margaret Varga, Technical Leader, Imagery Systems, and Dr Michael McMillan, Channel Manager for Pharmaceuticals and Biotechnology at QinetiQ, establish the value of cancer network clinical information systems  
Gerben Moolhuizen MBA and Leo GJ de Leede PhD at Octoplus, and Giulio F Paciotti PhD and Lawrence Tamarkin PhD of Cytimmune Sciences Inc, present Colloidal Gold Nanoparticles as a New Approach to Target Tumour Necrosis Factor to Solid Cancers  
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Science & Innovation: Asthma Focus
As a single agent does not cause asthma, discovery of a 'one size fits all' allergy vaccine is unrealistic. In Obstacles Ahead for Asthma Vaccines, Lisa Frawley, Respiratory Analyst at Datamonitor Healthcare pinpoints the issues  
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Special Focus: Central Labs
In Pharmacogenomics and the Impact on Central Laboratories, the need to meet procedural demands are discussed by Michelle Lynskey, Business Development Analyst at ICON Laboratories, Europe  
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