All EU Clinical Trials Regulation (EU CTR) articles
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JournalImplementation of Regulation (EU) No 536/2014 – A CRO perspective
Significant changes have been implemented to the clinical trials application process with Regulation (EU) No 536/2014 (European Union Clinical Trials Regulation; EU CTR) taking effect on 31 January 2022. This article summarises experience gathered under the new regulatory framework from a contract research organisation (CRO) perspective working ...
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PodcastsRegulating Vaxzevria
Vol. 20 #4
MEMBER EXCLUSIVE:
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]. Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria. -
JournalEvolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR
The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs).
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EditorialMind the gap:
Innovation vs
regulation of ATMPsTechnology has always developed faster than regulation – but the pace at which science is advancing is not being matched by progress of the current regulatory framework which, in stark contrast, is consultative, slow, and regional.