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European Pharmaceutical Contractor

epc
Winter 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
In her Editor's Letter, Julia Lloyd Parks reviews the articles featured in the Winter issue

 
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Keynote Article
Reviewing the WTO Negotiations on Medicines for the Developing World, Dr Trevor Jones, Director General at the Association of the British Pharmaceutical Industry, argues that greater involvement from wealthy countries is needed in order to achieve a lasting difference  
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Marketplace & Business
Stuart Pavelin, Senior Director, Consultancy Group at PharmaVentures, explains how alliance management can unlock maximum value from an organisation's portfolio of collaborations, in Alliances - A Key Source of Industry Value  
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In Translating the Pharma Industry, Geoffrey Bowden, General Secretary of the Association of Translation Companies, offers some advise on how to select the right translation supplier for you  
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Clinical Trials
Today it takes around 15 years to develop a new drug from synthesis to NDA approval. Dr David Griffiths, Head of Business Development at LCG Bioscience, suggests the need for change in Streamlining Phase I Through a Successful Partnership Strategy  
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Why Conduct Clinical Trials in Central and Eastern Europe? Dr Jean-Pierre Tassignon, Executive Vice-President at PSI Pharma Support Intl, contends that the vast reserves of patients in Russia and Central and Eastern Europe will spell an end to the 'no-fault' approach to delays in clinical drug development  
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Cornea Venter, Senior Data Manager, Biometry Division, and Daleen Krige, Medical Writer, Biometry Division at Farmovs-Parexel, give us a lesson in Avoiding the Pitfalls when Completing a CRF  
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In Clinical Trial Recruitment and Retention: The Challenge of Creative Communications, Emma Sergeant, Managing Director and Alison Eden, Creative Director at Fast4wD, stress the importance of communicating to your target audience on all levels in order to achieve speedy and appropriate patient recruitment and retention  
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The ICH E5 is designed to expedite the global development and availability of new medicinal products without impacting established safeguards relating to quality or safety between ethnic populations. Dr Jцrg Tдubel, Managing Director of Richmond Pharmacology, reviews the issues in Bridging Studies - What Questions Should be Asked in Phase I Clinical Research?  
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Dr Sue Miles, Chief Executive of Quantum Research, gives us a rundown on the Current Regulatory Authority Stance on Electrocardiogram Data in Clinical Trials  
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Legal & Regulatory
Ray Miller, President of Miller Regulatory Consulting, Inc asks Why the US FDA is Rethinking 21 CFR Part 11 and What Can We Do Now?  
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In Extending a Patent Portfolio, Graham Ruffles, Chartered Patent Attorney and European Patent Attorney at Marks & Clerk, examines some of the strategies available to pharmaceutical companies in order to extend the life of a patent  
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Johan Еkermarck and Juha Vдyrynen, Partners at Castrйn & Snellman, review Current Legal Issues Regarding Medicinal Products in Finland  
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Electronic Solutions
For over 15 years the industry has been engaged in discussions on how to improve the process of capturing data in clinical trials. Anders Hansson, Business and Data Management Consultant at VVTT, outlines The Most Important Current and Future Data Management Tasks ahead  
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Jane Baguley, Director at Cornaxis Ltd, argues that a more modest approach involving readily available technology applied consistently across an organisation can have surprising benefits, in e-Meetings and e-Learning - How the Internet can be Harnessed to Achieve Efficiencies in Clinical Drug Development  
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Patient Diaries
Which Patient Diary for Which Trial? Serge Bodart, CEO of Symfo (USA) Inc, suggests a criteria for choosing the best electronic patient diary for a trial, thus ensuring accelerated FDA approval for sponsors  
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Dr Brendan J Murray, CEO of Avalis AG eClinical, John Hutton, Vice President of European Operations and Head of Global Health Economics, and Dr Andrew Lloyd, Research Scientist for MEDTAP International Inc, give their view on Next Generation Electronic Patient Diary Applications in Life Cycle Management and Economic Outcomes  Studies  
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Recent research articles have exposed the limitations of paper diaries and questionnaires in the collection of patient-reported outcomes data. Dr Bill Byrom, Product Development Director at ClinPhone Group Ltd, responds with Technology Solutions for the Collection of Patient Reported Outcomes Data  
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Drug Development & Delivery
In Poly(ortho esters) - A Bioerodible Polymer System Specifically Designed for Drug Delivery, Jorge Heller, Principal Scientist at AP Pharma, examines an important class of biomaterials that are assuming an increasingly vital role in drug delivery, orthopedic applications and tissue engineering  
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Diabetes Focus
Type 2 diabetes is at epidemic levels - it is estimated that there are more than 175 million diabetes sufferers worldwide. Ehud Arbit, MD, Vice President, Medical Research at Emisphere Technologies Inc, looks to the future, in Diabetes and the Potential of Oral Insulin  
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Sara Hasan, Hyperbaric Nurse Consultant, Peter Dodds, Manager, Hyperbaric Medicine Unit, and Phil Catling, Business Group Manager, Electro-Optic Systems at QinetiQ, evaluate Hyperbaric Oxygen Therapy and Diabetes in this developing drug delivery sector  
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SARS Update
In SARS: A Postmortem, John Savopoulos, Lead Analyst of Infectious Diseases at Datamonitor Healthcare Europe, looks back on the pharmaceutical industries' response to SARS and critiques whether, one year after the initial outbreak, we are closer to understanding and preventing another outbreak of the disease

 
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LABS & Logistics
Jamie French, Operations Manager at Biocair, identifies the key issues facing logistics providers that must be faced in order to satisfy client's expectations of more efficient and successful trials, in Clinical Trials - Meeting the Logistics Challenge  
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Central Labs
How does a central laboratory assure its clients of the quality of the data being generated in its operation? Clare O'Sullivan, Laboratory Manager at ICON Laboratories, provides the answers in Central Laboratories and the Importance of an Effective Quality System  
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Manufacturing Environment
Diana Raine, Business Manager for Cryogenics in Europe at Air Products, considers the ramifications of legislation designed to curb air pollution for pharmaceutical industry manufacturers, in IPPC Drives the Emissions Control Agenda  
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In Automation in a Validated Environment Fuels Big Business Rewards, Walfried Laibacher, Validation Services Leader, Honeywell, Europe, elaborates on the advantages of automating record-keeping systems  
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White Papers

Microalgae Culture Using the DASGIP® PBR4 Module for Illumination with a New Brunswick™ CelliGen® 310 Stirred-tank Bioreactor

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Industry Events

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Join the calendar event highlight for the medical device industry at Europe's leading 10th annual conference and exhibition on Pre-Filled Syringes when it returns to Central London on 17th and 18th January 2018. Pre-Filled Syringes Europe will once again provide a perfect platform to discuss new advancements and showcase the latest innovations to keep you at the forefront of a dynamic and booming market.
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