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European Biopharmaceutical Review

ebr
Spring 2006
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR 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 of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR
   
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July, and October

News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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