From the scope of work presented in this chapter it is very evident that the CIOMS working groups have made significant contributions to present-day pharmacovigilance practice, especially in their attempts towards achieving harmonisation.
CONCLUSION
From
the scope of work presented in this chapter it is very evident that the CIOMS
working groups have made significant contributions to present-day
pharmacovigilance practice, especially in their attempts towards achieving
harmonisation. They have frequently focused on areas for simplification,
clarification and harmon-isation of practices on topics that are rarely or
never addressed by regulations or guidelines. Much of the success of the
working groups was due to the realisa-tion of the vision of Zbigniew Bankowski,
the Secretary General of CIOMS until his retirement at the end of 1999. This
vision was that problems could best be solved by small working groups of
constructive indi-viduals gathered together to represent different aspects of a
shared problem in an unofficial environment.
The
work of safety surveillance and public health protection is never completed
because regulations and requirements are constantly changing. Innova-tions and
improvements will always be needed and, with finite pharmacovigilance resources
in both indus-try and regulatory authorities, we must all do our outmost to
maintain the vision that pharmacovigilance is about promoting public health and
not bureaucracy.
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