RENATO RJAVEC
Director of Product Management at Amplexor Life Sciences, Czech Republic

Abstract

Amplexor’s closest industry partners and BE THE EXPERT event speakers review the major milestones in the Life Sciences Regulatory sphere in 2022 and predict developments 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.

Remco Munnik (RM): Up to now, Regulatory has always been the spider in the web within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc – then compiling a valid eCTD by the submission deadline. Up to now this process has ...