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.
- Russell Joyce, Director of the Health Sciences Records and Archives Association (HSRAA) and Director & Principal Consultant for Heath Barrowcliff Consulting Ltd.
- Rob Jones, Principal Business Consultant, Arkivum.
You can watch the recording of the webinar by completing the form below.
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Webinar Recording: The meaning and impact of Regulation (EU) 536/2014
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