Conclusion
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In conclusion, the new European legislative provision requiring risk management systems to be in place for particular medicines signals a change in regulation from a largely reactive to a proactive approach to pharmacovigilance.
CONCLUSION
In
conclusion, the new European legislative provision requiring risk management
systems to be in place for particular medicines signals a change in regulation
from a largely reactive to a proactive approach to pharmacovigilance. The
focus on regulators approving risk management plans, utilising appropriate
expertise and data resources, needs to shift to monitoring their effec-tiveness
in practice. A climate of greater transparency and openness about risk
management plans would help manage public expectations and foster greater
understanding of the fact that no medicine is risk-free. Finally, the case for
risk management to begin early in drug development, in the form of a
Development Risk Management Plan (DRMP) has been well set out in the Report of
the CIOMS Working Group VI. The worldwide alarm at the life-threatening
reaction in health volunteers receiving the monoclonal antibody TGN 1412 first
in man studies in the United Kingdom in March 2006 can only strengthen this
case.
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