Conclusion

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

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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