Regulation EU 536/2014 Clinic
Watch the recording of the session below
With Regulation EU 536/2014 officially coming into effect on Monday 31st January 2022, Arkivum hosted a Regulation EU 536/2014 clinic.
In the presentation, we provide an overview of the regulation and insights into the implications for clinical research documentation, and systems used for the generation, processing, management, and retention of documents and data such as the Trial Master File (TMF).
After a short presentation, the session opens for Q&A.