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An aviation perspective of safety in the pharmaceutical sector

In order to rebuild society’s confidence in the safety of medicines, we suggest the fragmentation, increasing complexity and inefficiency of the pharmaceutical safety system might be addressed by extrapolating from best practices of other safety conscious sectors. This is consistent with what the Institute of Medicine advised in their seminal report in 2000. Research from the MIT Department of Aeronautics and Astronautics has shown that modern socio-technical systems are becoming more complex and tightly coupled in response to demands for increasing performance and cost requirements. Thus understanding such systems and analysing how processes behave have become correspondingly harder. This is well illustrated by the example of how the EU pharmacovigilance guidelines have increased in complexity from the first version published in 1999 and the final version of Volume 9A released in March 2007. In both versions are the words ‘The marketing authorisation holder must ensure that it has an appropriate system of pharmacovigilance in place in order to assure responsibility and liability for its products on the market and to ensure that appropriate