监管事务的数字化转型白皮书

Digital Transformation ofRegulatory Affairs Table of contents Introduction1Legacy RA operations need anevolution2The value of the global RAevolution3AI is not the future story. It is the maturity test5The document mindset is holding the function back5Positioning global RA as a strategic differentiator6Final thought7 Introduction Global Regulatory Affairs (RA) teams have made tremendous strides in movingfrom the broom cupboard to the boardroom in many companies, however,insome organizations, they still struggle to be seen as a professionalmarket-accessfunction. registration approval data, to correspondence andcommitments with global regulatory agencies, to labelingchanges and product lifecycle management activitiesthat can affect a submission’s status, has become harderto manage with legacy ways of working that often usespreadsheets, SharePoint sites and emails blended withlegacy technological systems. The benefits of global RAprofessionals leveraging AI and end-to-end automationare no longer side conversations. Their value in a rangeof use cases including, but not limited to, submissionauthoring support, submission content review, changedetection and impact analysis, and submission operationsis being actively discussed in many RA forums. Yetmany organizations are still asking their global RAteams to work across disconnected systems includingspreadsheets, emails, shared drives, and local trackers. RA professionals can often be viewed as part of anadministrative function that is engaged in transactionaldocument activities with global regulatory agencies.The result of this is that, when it comes to productdevelopment activities, they are pulled in late to projectdiscussions, have to retrospectively create a globalregulatory strategy rather than optimize a globalapproach from the beginning of a development project’sinfancy, and often need to engage in acceleratedremediation activities and close out gaps that couldcreate delays in global submission and registrationapprovals. When RA teams are viewed as a necessaryevil, rather than a respected, strategic, market accessfunction, an organization is introducing risk into theirdesign and development projects that can createsignificant delays to market launch times, revenuegeneration, and patient access to healthcare solutions. The uncomfortable truth is that if RA is working in sucha manner then much of their time is being invested intransactional activities, reconciling data, and holdingtogether disparate systems rather than being focusedon professional RA activities that support innovation,commercialization and patient impact activities.The global RA function has to move from documentcoordination to decision support, and it does not havethe luxury of waiting as any delays impact patient accessto healthcare solutions. An evolution of perception and execution is neededwithin organizations if they are to maximize the talentavailable within their global RA teams. The global regulatory environment has changed ata faster pace than many organizations’ global RAoperations. Global RA professionals are managing anincreased number of regulated markets, with increasinglocal variation, ever-evolving requirements, and areduced room for error in global RA operations. Thevolume of information global RA teams track, from RIM solutions. This technological evolution has thepotential to transform not only global RA teams, butalso a company’s approach to design, development, andinnovation, creating significant opportunities to improvecommercial performance and operational execution. Legacy RA operations needanevolution Global RA teams often define success with submissionapproval rates, the reduction in questions and queriesfrom global agencies, and the timeliness and predictabilityof global registration approvals. Behind each of thesesuccess criteria is a team of RA professionals who connectdisparate systems, curate information to meet localrequirements, and engage with global regulators to ensurethe company maintains a credible presence throughoutthe submission process. This work is still absolutelycritical;however, the evolution to empowering teamswith end-to-end, AI-enabled Regulatory InformationManagement (RIM) solutions removes much of thetransactional, administrative burden and opens up globalRA teams to spend more time on professional, scientific,engaged activities that drive optimized registrationapproval times and improved market access. In effect, the adoption of digital, AI-enabled RIMsolutions, coupled with a shift toward recognizingglobal RA teams as critical contributors to innovation,is elevating more RA professionals from the broomcupboard to the boardroom as trusted strategicadvisors. However, for companies that claim to be modernizingglobal regulatory activities when all they have done isdeploy a new system while leaving their operating modelunchanged, that is not transformation. If RA teams still have to reconcile registration dataand submission conten