In the decade since the European regulatory systems were fully implemented in 1995, the concepts of risk management have developed and evolved in the light of growing knowledge and experience.
Risk Management - a
European Regulatory View
In
the decade since the European regulatory systems were fully implemented in
1995, the concepts of risk management have developed and evolved in the light
of growing knowledge and experience. The term ‘risk management’ may be broadly
defined as the identifi-cation and implementation of strategies to reduce risk
to individuals and populations, while a risk manage-ment plan in relation to a
particular medicine has a specific interpretation set out in European guidance.
The
principles of risk management informed the ‘2001 review’ of European
Legislation, which was adopted in 2004 and was subsequently the subject of
detailed guidelines. It is often said that regula-tion follows science; in the
case of risk management, regulation has followed not only scientific and
tech-nical progress, but growing public expectations that the systems for
monitoring the safety of medicines are optimally effective.
Risk
management in Europe faces particular chal-lenges. The regulatory systems
depend on the collec-tive functioning of a network which now comprises 26
national agencies (2 in Germany), with the European Medicines Agency (EMEA)
performing a supervisory and co-ordinating role. This chapter therefore has two
interrelated themes: the scientific and regulatory basis for risk management in
Europe, and the organisational and operational delivery of this approach to
pharma-covigilance.
Much
remains to be done to maximise the bene-fit of the new legislative basis for
risk manage-ment in Europe, and yet additional options to further strengthen
pharmacovigilance systems are already under examination. Several initiatives
are in hand involving a range of stakeholders, and the way forwards is a matter
of wide debate. Judging by the number of initiatives and discussion fora, the
further development of European risk management may be long term.
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