Module 3 2019

Example of Quality Issues (5)

CMC information included 4 QP certification sites (2 x UK and 2 x EU) Misunderstanding with regulatory function resulted in only the 2 EU sites being included in the EudraCT form EudraCT form was not reviewed as part of regulatory confirmation… Certification from UK site. Had to be re-certified from EU site to enable use in the trial.

Submission to add UK sites back in is Brexit dependent…

The Organisation for Professionals in Regulatory Affairs