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International Clinical Trials

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Summer 2006
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. ICT 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 ICT
   
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Pam Barnacal introduces the inaugural ICT in her Editor’s Letter
 
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Keynote
Are commercial concerns interfering with standards in the pharmaceutical industry? As public attitudes come increasingly close to this standpoint, Dr Faiz Kermani at Chiltern International looks at what industry can do to turn opinions around, in Public Concerns and Clinical Research  
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Clinical trials in children are an ethical, regulatory and commercial minefield; Dr Richard Tiner at the Association of the British Pharmaceutical Industry guides us through how the landscape is set to change, in Medicating Minors: The Present and the Future  
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Following the UK Government's 2006 budget announcements, now is a good time to revisit the provisions of the UK's research and development tax relief. David O'Keeffe and Mark Hobbs at KPMG's Research & Development Tax Relief Group elucidate, in Money-Back Guarantee  
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Regulatory & Business Practice
Conducting clinical trials within the EU becomes even more complicated for non-EU companies. In Foreign Policy, Nicola Maguire and George Pickering at Reed Smith separate the Clinical Trial Directive, the Data Protection Directive and the national legislation implementing them  
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In Nordic Compassion, Hilde Kloster Smerud, Stian Brekke and Knut T Smerud at SMERUD Medical Research Group review the regulatory approaches for compassionate use programmes in the Nordic countries  
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Clinical Trial Management
Raimo Tanzi of Applied Biosystems asks 'Is the Cost of Personalised Medicine Really Too High?' in an in-depth focus on the drivers behind the development of these new therapeutics  
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In Turning on your RADAR: Making your Study Names Recruitment Friendly, Rob Laurens at BBK Worldwide persuades us of the benefits of thinking carefully about what your acronyms are saying about your clinical trials  
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What are the upcoming industry regulations, who is developing them and how will they affect your company? Find out with Jim Nichols at Thomson Scientific, Liquent Regulatory Solutions in Law and Order  
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Clinical Trial Outsourcing
If you're thinking of outsourcing, you may be deliberating over the relative benefits of global versus network CROs. John V Farinacci at ResearchPoint provides a helping hand, in Long Distance Relationships: Finding the Right Partner  
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With talk of India and Latin America as the young pretenders for global clinical trials, where does that leave Central and Eastern Europe? Sue Fitzpatrick of the Institute of Clinical Research looks at the advantages, in CEE No Evil eClinical  
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With talk of India and Latin America as the young pretenders for global clinical trials, where does that leave Central and Eastern Europe? Sue Fitzpatrick of the Institute of Clinical Research looks at the advantages, in  
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Integration is happening, and everyone says that they are doing it already, but what does integration in the eClinical industry really mean? Michael Harte and Richard Piazza at etrials provide the answers in Demystifying eClinical Integration  
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In Get Off at Data Central, Reza Farienfar at Viasys Clinical Services examines how collecting clinical trial data has been revolutionised from an exclusively paper process to centralised data collection as part of EDC, and looks at what it could do for your clinical trials  
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IT & LOGISTICS
In Taking the Strain Out of Training, Simon Burgess at Zenosis Ltd looks at how on-demand training can help companies stay abreast of regulatory changes  
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Global trial success depends upon effective multilingual, cross-cultural communications - Gary Muddyman at Conversis reports, in Clinical Trials Across Borders  
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CLINICAL THERAPEUTICS
Drug sales may be enormous but the level of unmet medical need for psychiatric and neurodegenerative disorders is alarming; Susan McGoldrick at QCTR Limited investigates in SOS from CNS  
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PREVIEW
Attending ICSE this year? Be prepared for The Whole World of Pharmaceutical Outsourcing Under One Roof  
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DIA Delivers in Philadelphia - yet another successful annual meeting for the Drug Information Association, as this event goes from strength to strength  
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Published quarterly in
February, May,
August, and November

News and Press Releases

SCHOTT Builds Second Melting Tank for Pharmaceutical Glass Tubing in Mainz

The international specialty glass manufacturer SCHOTT is building a second melting tank for pharmaceutical glass tubing at its main plant in Mainz, Germany. The investment volume amounts to 40 million euros. The new production facility is scheduled to go into operation in mid-2022 and will then offer 100 new jobs, 50 of which will be directly at SCHOTT. With this investment, SCHOTT is responding to the dynamically increasing global demand for glass tubing for pharmaceutical packaging.
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White Papers

Analysis of Biopharmaceuticals to Conform to ICHQ6B

RSSL

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%. In 2010 the average medicines expenditure per person within the UK was 271, and this is expected to increase with the ageing population. A significant and increasing proportion of these sales are protein-based biotherapeutics or biomolecules. Currently, these account for 19% of the total market, and are growing at twice the rate of traditional small molecule pharmaceuticals. It is predicted that close to 50% of the top 100 pharmaceutical products will be biomolecules by 2016. By far the largest segment of the biopharmaceutical market is the monoclonal antibody (MAb) with an estimated share of 25.6%, which corresponds to USD 51.1 billion.
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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