December 8th, 2017
With Christmas just around the corner, it is time to reflect on the past year. A very challenging one for clinical R&D in particular. Obviously, the most impactful change concerned the regulatory revisions: i.e. ICH GCP E6 R2, which was adopted in last June. Its new fifth chapter now pushes the pharma industry into the exciting world of risk management.
As a result of this excitement, projects such as ADAMON and PUEKS have published their results: here and here.
In addition we just learned that EMA will relocate to the Dutch historical capital as a “side effect” of BREXIT. The rumor goes that quite a number of pharma companies already started acquiring properties in Amsterdam to form new lobby groups…..
If you’d ask us, we would focus our efforts on solid processes instead. So before you set your New Year’s resolutions may we suggest you one? Start 2018 with an easier way to manage, assess and mitigate your clinical risks. This would save you more time and energy than what any lobby in Holland could do for you.
Coming soon: @RACT-Pro
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