Module 5 Presentations

05/07/2024

Member States Supervision and Union Controls

• As a Regulation, CTR introduces Union Controls of CTR implementation • Mechanisms also exist to allow for Regulatory Authorities to make inquiries (ad hoc RFIs), suspend or stop the trial (corrective measures) • CTR Art.77: Corrective measures to be taken by member states • Revoke authorisation, Suspend Clinical Trial, Modify Clinical Trial • CTR Art.78: Member States inspections • CTR Art.79: Union Controls (European Commission oversight of CTR implementation by MS) Note: In CTIS, option for MS ad hoc assessments (RFIs triggered out of a specific evaluation procedure) and Sponsor opinion on Intended corrective Measure

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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3. Clinical Trial Maintenance (comparative review CTD / CTR)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

32