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International Clinical Trials

ict
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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs

Philadelphia, USA Ė February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
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White Papers

Challenges of Analytical Method Transfer in the Pharmaceutical Industry

RSSL

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
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Industry Events

Clinical Trial Supply Global Forum

20-22 May 2019, Brussels, Belgium

You canít get a drug to market without a clinical trial. You canít run a clinical trial without product supply. We understand that your role is critical in ensuring the on time and efficient development of the next life saving drug and we know that this makes your time precious. In 2019 we have condensed everything you need to advance your Clinical Trial Supply into three jam packed days. The industry's most interactive and solution focused CTS forum features deep dive workshops, live polls, panel debates, round table discussions and exclusive key note case studies to ensure that you leave with the industry's best solutions and strategies to transform your clinical trial supply. If there is ONE Clinical Trial Supply conference that you attend in 2019, make sure that it is this one.
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