Apr 29, 20221 minEMA Implements E8(R1)EMA formally implements ICH E8(R1). That's good for RBQM and the 'quality continuum' with E6(R3).
Nov 9, 20212 minName names to successfully implement RBQMOver 50% of organizations we surveyed didn't have a named person responsible for RBQM implementation.
Oct 19, 20212 minRBM/RBQM take up is slow according to ACRO, but it’s improvingRBM/RBQM take-up before the pandemic was slow. It's picking up, but there's still a long way to go.
Aug 24, 20212 minI agree with the ICH E6(R3) EWC - Change is the greatest challengeMacarena Sahores discusses why Change is the greatest challenge facing the sector
Jul 19, 20213 minThe Quality ContinuumDuncan Hall discusses the new concept of a "Quality Continuum" in relation to ICH E6(R3), and what it means in practice for your trials.
Jun 3, 20212 minTop 3 points from ICH E6(R3)My top 3 points from the recent ICH E6(R3) update were: Increased focus on quality and links to E8 and E9; The increasing importance of...