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European Pharmaceutical Contractor

A Different Strategy in a Changing World of Infectious Substances

On the 5th July 2002 UN scrutinisers voted unanimously passing far-reaching legislation for the next edition (13th revised edition) on infectious substances. It is quite remarkable, considering that only a year ago it would have taken a days spirited debate just to change a few words in the existing text. Was there a momentous sea-change by experts on their views of dangerous bugs? Or did other influences come to bear? Think back to the autumn of 2001.

The deliberate release of biological agents through the mail system in the United States completely changed the focus on hazardous materials. 'Hazmat' bioterror swiftly shot up the political and scientific agenda. Many governments, particularly in North America and Europe, took measures to increase preparedness and response capacity. Therefore, not surprisingly, transport officials needed to open a dialogue with the scientific community and start to understand the rationales which underpin the infectious substance class. This UN meeting was the culmination of a year's solid work for regulators and scientists. Many observers agree that the impending '13th revised edition' is unequivocally a positive regulatory milestone. Now it remains to be seen how the world will progress in the intervening years until it is published in 2004.


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By David Cocker of MDCPartners

David Cocker is a Biomedical Engineer who began his career in 1977 with Townsend and Mercer London where he was responsible for technology and training in medical imaging. In 1980, David set up his own company in Sydney, Australia, working exclusively with the Australian Red Cross, designing and automating parts for their blood products production.

He then moved to Germany and took up the position of Marketing Director for Boehringer Ingelheim's institute Bioscientia, and from this time has held senior positions in a number of leading European clinical laboratories. He was Founder and General Manager of Medinet in the Netherlands, General Manager for Quintiles European laboratory services and was most recently Managing Director of Clinical Research Laboratory (CRL), based in Brussels.

David was a founding member of the European Bio-safety Association. He is also a consultative member on the UN committee of experts on dangerous goods and formal consultant to the WHO on biosafety issues concerning international transport of biological substances.

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David Cocker
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