Quick guide for sponsors – Regulation 536/2014 in practice, dated 28 August 2023, version 03 has been published

On September 14th, 2023 version 03 of the ‘Quick guide for sponsors – Regulation 536/2014 in practice’ (dated 28 August 2023) was published on EudraLex Volume 10 ‘Clinical Trials’.

Changes compared to superseded version:

  • Added: Section 3.2.1 Addition of MSC and IMDPQ for decentral point of care
  • Revised section 1. with updated guidances and best practice for sponsor to transition clinical trial from CTD to CTR

A copy of the document can be downloaded from EudraLex Volume 10, or directly via the link here below:

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