The EU (536/2014) CTIS Database Has Been Approved – What Happens Now?

In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

For this Clinical Leader Live I spoke to Sylvia Marecki, Marieke Meulemans, Adam Lambert, and Thomas Hagemeijer about the opportunities and challenges of EU (536/2014). In this segment, Adam Lambert and Sylvia Marecki discuss what happens now that the CTIS database has been approved, where companies can go for help, and what companies need to be thinking about as new deadlines near.


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