Phlexglobal Issues Industry Advisory on New EMA Trial Master File Guidance

Comprehensive guidance took effect June 6, 2019; will significantly impact sponsor and CRO compliances

shutterstock_679945117

Amersham, UK; Malvern, PA. June 20, 2019 — Phlexglobal today announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance took effect on June 6, 2019, and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.

 

 

Digital Brain Header Large Brain Right

It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
Contact Us

Latest News

CDISC ‘26 Recap: Why a Portfolio View is the Missing Piece in TMF Oversight

Shifting the Lens: Why a Portfolio View is the Missing Piece in TMF Oversight At CDISC Europe 2026, we explored a simple but important idea: the challenge with TMF metrics isn’t what we measure -

CDISC ‘26 Recap: TMF Culture & Engagement: Bringing Everyone Under the Same Umbrella

As a first-time attendee of the CDISC conference, this year held in Milan, I had the great opportunity to meet like-minded and influential figures in the space, as well as present my poster on TMF

CDISC ‘26 Recap: What Real TMF Collaboration Looks Like

This year’s CDISC conference in Milan was especially meaningful for me. It was my first time attending, and I had the privilege of presenting alongside Jason Weinstein from Regeneron, a long-time