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International Clinical Trials

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Autumn 2008
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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Regulatory & Business Practice
Tim Worden of Taylor Wessing LLP discusses the MHRA’s investigation into GSK’s reporting of adverse events in Seroxat paediatric clinical trials  
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Sarah Powell at Liquent examines the results of a 2008 regulatory affairs trends survey of the pharmaceutical industry  
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The latest European Court ruling fails to resolve parallel trade uncertainty, reports Edward Miller of Reed Smith  
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Clinical Trial Management
Nicola Murgatroyd of Phlexglobal Ltd explains how finding and keeping people with the right skills, from secretaries to a highly experienced clinical research professionals, can energise a company  
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Angus Cameron at Pharmarama gives his advice on deploying comparator drugs in China for global clinical trials  
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Steve Toon of Simcyp Limited argues that the pharmaceutical industry must tap into the real value of modelling and simulation in drug ADME  
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Colin Garner and Graham Lappin at Xceleron explore safety testing of drug metabolites and look to gain a better understanding of human drug metabolism at an earlier stage  
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eCLINICAL
The convergence of electronic health records and clinical research is changing the way the pharmaceutical industry operates. Jacob Helton, Landen Bain and Rebecca Daniels Kush of the Clinical Data Interchange Standards Consortium (CDISC) and Linda King of Eli Lilly and Company investigate an evolving landscape  
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Urban Fröderberg of Anoto AB examines how digital pen and paper technology, as a relative newcomer among data capture tools, can help address some of the hurdles encountered by CROs  
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Robin Longdin of LCG Bioscience and Nick Townsend of LabWare Europe discuss the introduction of a new-generation laboratory information management system (LIMS) into a busy Phase I clinical trials facility  
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Portable software helps monitors manage site visits, validate protocol compliance, and assess the integrity of trial data, insists John Humphreys of Perceptive Informatics, a PAREXEL International company  
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THERAPEUTICS
Mike Wyllie of Plethora Solutions charts the trends in urological drug development – an untapped market where medical need is at present poorly met  
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Labs & Logistics
Don Riach at Marken reviews the challenges of transporting diagnostic blood samples back to central laboratories in a timely manner  
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Jeff Clark of BioStorage Technologies Inc reveals how in-home clinical trial service mitigates risk with a strategic, holistic approach to cold chain management  
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Natasha Molnár of SCA Cool Logistics asks whether it is possible to find a packaging solution which ticks all the right temperature-controlled boxes  
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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 Appoints New Chief Financial Officer SVP Serge Dupuis

Philadelphia, PA – 22 March, 2019. Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to welcome Serge Dupuis as Senior Vice President and Chief Financial Officer (CFO).
More info >>

White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

CPhI & P-MEC China

18-20 June 2019, SNIEC, Shanghai, China

CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
More info >>

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