Life Sciences Regulatory experts share predictions for 2023

WHAT, FOR YOU, IS THE SINGLE BIGGEST ISSUE OF IMPORTANCE IN RELATION TO THE REGULATORY FUNCTION RIGHT NOW, AND WHY?
Steve Gens (SG): It has to be improving global ways of working. Decreasing the time for market approvals has been the biggest area of focus and progress, not least having witnessed biopharma companies with COVID-19 products being able develop and gain regulatory approval in record time.

Never in our history has getting products to patients been so critical, and new approaches developed to accomplish this, something we’ve been tracking closely. We’re seeing new ways of working, increased application of modern technology and digitization, and good old-fashioned process enhancement (change control, label management, regulatory intelligence) at an end-to-end level.