JUNE 2023LIFE SCIENCES REVIEW 19their high thyroid stimulating hormone. So patients would be informed of their individual risk, rather than the general arrhythmia incidence with product X being "rare."Risk Management & Risk Minimization Current: new risks are communicated via "Dear Doctor Letters" (yes, snail mail!)Future: What if... they are communicated via a central App?Imagine a "Facebook" for medicinal products. Users "follow" their products (those they use or prescribe) and get notified of relevant new information, always at their fingertips when they need it ­ not when the company needs to send it. Think about the printing and mailing costs saved, and the less "noise" created compared to media alerts for patient level recalls, for example.Quality Management SystemCurrent: hundreds of Standard Operating Procedures(SOPs)Future: What if... no more SOPs, no more trainings, no more non-compliancesCompliance and Quality Management considerations have made us believe that "there is no problem which cannot be solved with a more extensive SOP." These have to be written, updated, trained, and their implementation controlled, resulting in deviations, audit / inspection findings, Corrective and Preventative Actions (CAPAs) which more often than not include "let's write / add something to an SOP"-and the circle starts again.What is the ideal number of SOPs? Zero.Once processes are hard-wired into workflows, the computer carries the task from person to person (or from bot to bot) with context and relevant instructions on how to perform the task. So no more need to remember the content of the training done six months ago.Who has ever received an SOP on the process of reimbursements? It is a simple "yes / no / back with questions" task, the rest is done by the computer, so there is no need to know all process steps. Why not do this with other processes?What's next?So, yes, seemingly infinite possibilities inspired by new capabilities brought by technology can help us to think differently ­ not from the PV department perspective but from the patient perspective, and then backward engineer from there.Thinking approaches from the patient require us to break down silos, silos between countries and companies. Patients will not want to have 1W0 label Apps and 10 AE reporting Apps on their smartphone, for the 10 products they take, all with different functionalities and different User Interfaces. They will want one App for all products. Digitalization means Globalization and requires a true patient-centric focus, not a company-centric focus. Collaborating on digitalization in PV is an opportunity to deliver on patient centricity and to reduce costs, improve compliance, and increase employee motivation along the way. Digitalization means Globalization and requires a true patient-centric focus, not a company-centric focus
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