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European Biopharmaceutical Review

Present and Future Challenges in Management of Critical Documentation over the Entire Product Life Cycle

The Sixth International Conference on Harmonisation (ICH6) took place in Osaka, Japan, from 12th to 15th November 2003. With a view to determining future challenges for the ICH process in the evolving pharmaceutical environment, the conference focused on areas such as new technologies in the discovery of innovative drugs, opportunities and new challenges for regulatory harmonisation, pharmacovigilance and global co-operation with regulatory harmonisation initiatives outside the ICH regions. The practical implementation of the Common Technical Document (CTD) and the electronic Common Technical Document (eCTD) were an important focus of the conference.

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By Jim Cook, Senior Vice President, Product Marketing and Strategy at Liquent

Since co-founding CDC Solutions (acquired by Liquent in December 2003) in 1994, Jim Cook has worked to develop a stream of pioneering software products that leverage CDC Solutions' core strengths in content delivery and electronic document publishing technology. As the chief designer and architect of the PDFfusion and EZsubs publishing suites, Jim has been at the forefront of the technology industry for some 20 years and is responsible for setting the company's technical direction.

Prior to his career with CDC Solutions, Jim worked for PricewaterhouseCoopers Kinesis where, as Principal Consultant and Project Manager, he led a series of enterprise level document management and publishing initiatives, making him an early pioneer in content delivery. Jim is a Chartered Engineer and holds a Bachelor of Science degree with honours in Electrical and Electronic Engineering from the University of Bath, UK.

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Jim Cook
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