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The Impact of the EU Clinical Trials Directive on the Supply Chain

The European Union is about to enter a new era in the conduct of clinical trials within its jurisdiction. The vastly different range of current approaches from member states to trials are going to converge on 1st May 2004. At least that is the intention. Will we make it on time or will national differences on interpretation make it impossible? Not only that, but how will the new accession countries intending to join the EU in May 2004 fare? In both cases, only time will tell.

This article broadly highlights certain aspects of the changes to clinical supplies as demanded by the Directive (1) and encouraged by the accompanying publication of guidance in the revised Annex 13 (2) to European Good Manufacturing Practice (GMP). Readers may find that these changes already exist in many Member States' legislation, but in most countries the requirements are new.


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By Paul O'Connor, Head of Quality at Clinical Trial Services

Paul O'Connor graduated from the University of Ulster in 1994 with a BSc in Applied Biochemical Sciences. He has spent nine years in various pharmaceutical quality roles, first with Galen Ltd and subsequently with Clinical Trials Services. He is the Head of Quality for the organisation which is based in the UK, Pennsylvania and North Carolina. The company regularly provides clinical trial packaging, analytical and distribution services for 18 of the top 20 pharmaceutical companies. He is also one of the company's Qualified Persons and advises many overseas pharmaceutical companies, particularly those from the US and Japan, on release of their supplies into European Union countries.

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Paul O'Connor
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