Clinical Trials Regulation In The EU: Preparing For Change
The European Union (“EU”) is introducing a new approach to how it authorises and regulates clinical trials across member states. Aon’s most recent Global Risk Management Survey found that life science companies rated “failure to innovate” and “regulatory change” as two of the biggest risks they face. For life science companies, the new regulation is at the intersection of these two risks. Clinical trials offer life science companies the route to innovate and develop new products that adapt to patient needs, and are thus at the core of their future revenue pipeline. Clinical trials also represent one of the most highly regulated environments any innovative business in this industry has to face. So adapting to regulatory changes is a challenge of great consequence to life science companies.
This paper highlights how the new regulation may impact those seeking authorisation for clinical trials in the European Union, and in particular how the change will impact on sponsor’s requirements for the provision of insurance for trials conducted in member states.
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