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.
We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts
Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or
Introduction: Trial Master File (TMF) experts are acutely aware of the growing complexity involved in meeting compliance obligations and improving overall quality and completeness. As those working
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
Poland: +48 81 45 46 132
Germany: +49 89 23514741
E-Mail: info@phlexglobal.com