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.
Related Topics
TH 2019 - 2024 pharmacy180.com; Developed by Therithal info.