Adapted from an April 2019 Phlexglobal webinar presented by Eldin Rammell. For a more detailed discussion of the new ...

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

You’re responsible for preparing your Trial Master File for an upcoming inspection or audit. You’ve inherited some TMFs ...

Almost exactly 10 years ago – on the 23rd of March, 2009 to be precise – a pretty diverse group of about 20 TMF ...

It is interesting – at least to some of us! – that the management of trial master file content has developed into such ...