A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
Study sponsors have offered contrasting views in a survey conducted last year on their experience of voluntary compliance with the provisions of the EU Clinical Trials Regulation (CTR).
The survey - undertaken between 18 July and 9 September under the Accelerating Clinical Trials in the EU (ACT EU)...
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The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.
