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European Pharmaceutical Contractor

epc
Summer 2004
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 Summer issue

 
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EU Clinical Trials Directive Focus
UK Legislation - What's on the Horizon? asks Dr Richard Tiner, Director of Medicine at the Association of the British Pharmaceutical Industry  
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Patrick Martin, Partner at McGrigors, looks at the new Directive's effect on clinical trial outsourcing contracts, in Outsourcing of Clinical Trials  
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Marketplace & Business
The total market for CROs grew by over 11 per cent in 2003. In The CRO Scene in 2003 - A Brief Tour, Dr Graham Hughes, Scientific Director at Technomark, and Chairman of the EPC Editorial Board reviews the situation  
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In Operations in the Boardroom, Ian Brodie, Executive Consultant at Capgemini, emphasises the importance of achieving efficiency  
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Chris Tait, Life Science Underwriting Manager and Keith Gallois, Senior Loss Control Representative at Chubb Insurance Company of Europe, suggest ways to avoid financial pitfalls following implementation of the EU Clinical Trials Directive, in Risk: Without and Within  
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In Drugs for Life - How 'Lifestyle' Medicines can Lead the Way to Healthy Profits - Chris Every, CEO of Enhance Biotech, tells of a new age of 'wellbeing'  
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EU Expansion Focus
The European Union in effect doubled its member size to 25 on 1st May 2004. Dr Linda McNamara, Managing Analyst for Strategic Analysis at Datamonitor Healthcare, takes us through the implications, in EU Enlargement: Strategies for Pharma's Success  
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Vincent Henderson, Consulting Partner at Bowne Global Solutions, considers EU Expansion - Breaking Down the Language, Culture, and Consumer Communications Barriers  
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Clinical Trials
The route to Finding the Right Patients and Keeping Them is considered by Michaela Mahon, Managing Director, Healthcare Practice, and Gaynor Anders, Senior Account Manager, Healthcare Practice at De Facto Communications plc  
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Danny Tielemans, Quality Assurance Manager at MSOURCE Medical Development, looks at How to Implement ISO 9001 in a GCP/CRO Environment  
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In The Ins and Outs of Human ADME Studies, Dr Xavier Deroubaix, Project Director of Phase I and Dr Alain Coquette, Head of the Department of Biology at SGS Biopharma, Belgium, discuss the strengths of mass balance studies  
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Dr Anton van Weert, Managing Director of Heart Core bv and Professor Hans Reiber, Head of the Laboratory of Image Processing (LKEB) at the Leiden University Medical Center (LUMC) and General Director of Heart Core bv, examine Quantitative Image Analysis in Clinical Trials - Current Standards and Future Developments  
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Legal & Regulatory
In the European Court Opens a Small Window of Opportunity for Pharmaceutical Companies to Restrict Parallel Imports of Medicines, Catriona Hatton, Partner and Wim Nauwelaerts, Counsel at Hogan & Hartson LLP, get to grips with 'grey imports'  
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Adrian Tombling, Partner and Rachel Wallis, Associate at Withers & Rogers, review some of the possible ways to manage your patent portfolio more efficiently and cost-effectively, in Patent Filing Strategies - What Should you Consider?  
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India Focus
Subash Sadanandan and Tina Young, Company Directors of InDatum Ltd, UK, and InDatum Research Data Services, India, consider the benefits of Establishing Operational Sites in India  
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IT Solutions
No Better Time than the Present: Electronic Data Capture Comes of Age, contends Steve Powell, Vice President and General Manager, International Operations at Phase Forward  
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David B Stein, Director of Strategic Business Development and Marie MacDonald, Systems Manager at ClinPhone Inc, USA, and Bill Byrom, Product Development Director at ClinPhone Group Limited, UK, investigate the growing need to share data between information silos, in Integrating eClinical Systems  
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Clinical Data Standards: Where Next? - Dr C David Hardison, Board of Directors of CDISC and Vice President, Life Sciences, of First Consulting Group, Dave Iberson-Hurst, Founder of Assero Limited, and Dr Rebecca D Kush, President of CDISC, deliberate the possibilities  
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The advantages of IVRS over paper-based systems, and the changes that investigators using IVR technology for clinical trials can expect, are brought into focus by Andrew W Newman, IT Manager at Kendle International, in The Past, Present and Future of Interactive Voice Response  
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Drug Discovery, Development & Delivery
Dr Leo de Leede, Managing Director at OctoPlus Technologies, Dr Jeroen Bezemer and Dr Ruud Verrijk, Senior Scientists at OctoPlus Technologies, Dr Gert Bos, Project Manager, Devices, at KEMA Quality bv and Professor Wim Hennink, Head of the Department of Pharmaceutics at Utrecht Institute for Pharmaceutical Sciences at Utrecht University, put Controlled Parenteral Release of Pharmaceutical Proteins from Hydrogels under the spotlight  
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Within the next five years, it is expected that nearly half of all biopharmaceutical manufacturers may be outsourcing production of biologics to CMOs. In Manufacturing Recombinant Proteins: Facing Up to the Challenges of Making Tomorrow's Medicines, Tony Hitchcock, Associate Director of Microbial Products at Cobra, looks to the future  
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In QT Interval Prolongation and its Impact on Drug Development, Dr Radivoj Arezina, Director and Megan Bridges, Medical Writer at Richmond Pharmacology Ltd, place QT/QTc interval prolongation under scrutiny 
 
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Dr Jin Yan, Dr Atul Karanjkar and Martin Branagan, Healthcare Team at Fluent Europe Ltd, present a study using computational fluid dynamics simulation technology, in Dynamic Modelling and Simulation for Nasal Drug Delivery
 
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Therapeutic Innovation
Despite the availability of essential drugs, there is a high prevalence of clinical asthma in industrialised countries. Dr Angela Ning and Dr Elaine Robertson, Project Managers at Inveresk, introduce a discussion on Targeting the Future Needs of Asthma Treatment  
In Cancer Prevention: Taking Environmental Factors on Board, Andrew Trehearne, Head of Education & Communication at the World Cancer Research Fund UK, puts forward the value of a healthy lifestyle  
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LABS & Logistics
Geraint Thomas, Technical Director at Laminar Medica, encourages us to get on board, and look to the prospect of Sailing to Utopia: A Revolutionary New Phase for the Pharmaceutical Cold Chain Shipping Scene  
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Central Labs
With only 20-30 per cent of drugs labelled for paediatric use approved by the FDA, Kirk Daly, European Sales Director for CentraLabS Clinical Research, considers the pressure on pharmaceutical companies to modernise their approach, in Paediatric Clinical Trials - The Challenges Facing Central Laboratories  
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Review
Too busy to catch the latest DIA EuroMeeting? EPC reports back in Expanding Horizons - the DIA in Prague  
   
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News and Press Releases

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A new initiative for PPMA Show visitors this year is the Bright Ideas - Ambassador Programme - a free advice service for start-up ventures and entrepreneurs.
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White Papers

Conveying Medical Guidance in Clinical Trials – A Survey

Europital Medical Consultancy

With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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Industry Events

Drug Discovery 2018

9-10 October 2018, ExCeL Arena, London, UK

ELRIG’s flagship conference, Drug Discovery, has become the largest meeting of life sciences industry professionals in the UK. Now in its 12th year, Drug Discovery 2018 will take place in London’s Excel Arena. This 2-day event will bring together more than 1200 delegates and over 100 exhibiting companies from around the world who will highlight the latest ground-breaking research, discuss cutting-edge advances in the application of laboratory technology to understand disease biology and to identify novel chemical and biological candidate drugs.
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