EMA’s Trial Master File Guidance is in Effect. Are You Ready?

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

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Health Canada revises validation rules for eCTD format

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

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How New EU Regulations Will Impact Regulation of Medical Devices

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

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How to Transform TMF Quality Guidelines into Inspection-Readiness Habits

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

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10 Short Years Ago, the TMF Reference Model Was Born

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

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TMF as a Part of the Bigger Records Management Picture

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

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