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 harmonisation 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 realisation 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 individuals 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. Innovations and improvements will always be needed and, with finite pharmacovigilance resources in both industry 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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