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

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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.

 

 

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