Frederic Pailloux
Frederic Pailloux is Senior Director, Head Integrated Product Development & Consulting, Pharmalex, France.
JournalHM1: A decade of innovative clinical trials: What have we learned and where are we going?
The session gave some insight on the Accelerating Clinical Trials in the EU (ACT EU) and the EMA Q&As on CCTs, a guidance regarding scientific aspects and the planning, set-up and submission for CTA applications, as well as conduct, reporting, analysis and interpretation of CCTs.
FocusNew regulatory tools for drug developers: sharing experience
Advances of knowledge in therapeutic areas have led an ease in the development of and access to complex medicinal products. This article discusses the regulatory tools in drug development and regulatory science for drug developers.