Risk Management - a European Regulatory View

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Chapter: Pharmacovigilance: 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.


Risk Management - a European Regulatory View

INTRODUCTION

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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