TOBIAS HITZIGER
management consultant, MAIN5, Germany

Abstract

Across core late-stage pharma R&D functions including Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety, current process rigour and performance is linked primarily to SOPs. Yet these snapshot definitions of processes do not, of themselves, ensure efficiency. Indeed, the deliverables of those processes have too often become hazy and forgotten. MAIN5’s Tobias Hitziger reflects on the barriers preventing true end-to-end process transformation, and what is being lost as a result.

For a whole range of commercial and strategic reasons, there is now enormous pressure on life science R&D organisations to hone their operational processes and make these as efficient as possible. Soaring cost pressures, downward pressure on pricing and margins, intensifying global competition, and increased product sophistication/complexity are all palpable drivers for change that are becoming increasingly impossible to ignore. Certainly, once the clock starts ticking on a new product patent, speed to registration and maximised sales potential are paramount. All of this is increasing the impetus to streamline core processes and then, in many cases, apply technology appropriately.Yet, today, across pharma Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety functions, process rigour is dictated primarily by standard operating procedures (SOPs) and their evolution over time. SOPs are highly detailed, step-by-step descriptions of how things are done, to ensure a standardised way of working. Those SOPs are in most cases PDF versions of Word files, managed in an electronic document management system to ensure compliance. These snapshot definitions of processes do not, o ...