Transitioning to the new R3 Standard in the EU: Benefits, Impact, and Cross-domain Effects.

The life sciences industry operates in one of the world's most regulated environments. In this essay, we briefly recapitulate the regulatory developments that resulted in today's landscape, elaborate on the challenges of the change management process, and examples of the interplay between the E2B(R3) working framework and collateral activities in the ISO IDMP and CT-REG space.