满怀信心地加快全球市场准入：人工智能驱动的监管信息管理（RIM）如何改变合规性

Accelerate Global MarketAccess with Confidence How AI-enabled regulatory informationmanagement (RIM) transforms compliance ASHEETA ANAND, Director, Regulatory Affairs & Quality Assurance, Dentsply SironaJEREMY YUNG, Regulatory Affairs Director, Cynosure LutronicMIKE KING, Senior Director, Product & Strategy, IQVIA Table of contents Introduction1Sevenkey 1Global trends. Regional impact2The role and benefits of RIM3IQVIA SmartSolve®RIM: Streamline global complianceand accelerate market access4Resistance to change5Making the case for RIM6The peril of silos8AI and the future of RIM9Conclusion11Final thoughts from our RIM experts11About IQVIA12About SmartSolve®12About the authors13 Introduction The changing nature of global regulation andcompliance rewards agile minds and forward-thinkingorganizations. At the same time, it is testing thepatience of the very best practitioners in the field.Increased complexity, growing regional variations,constant updates, and ongoing concerns about dataquality combine to create barriers and challengesthat must be overcome. Seven key takeaways 1Spreadsheets are a symbol of cultural inertia.A sizeable minority of organizations continues to usespreadsheets, shared drives and other piecemeal toolsto manage regulatory information. This is indicativeof a cultural, as well as technological, challenge. 2Coping without a digital RIM solution is likeoperating without ERP.And that’s the situation manyglobal regulatory teams find themselves in today. At its heart, this white paper explores the present andfuture role of regulatory information management(RIM) and the value of professional, global regulatoryexpertise. It evaluates the merits of digital RIM solutionsbut also lays out why a sizeable number of organizationsremain resistant to change. This white paper seeksto understand that resistance, present the benefitsof digital RIM solutions, explore the role of artificialintelligence (AI), and offer advice and best-practiceexperience about adoption. 3Rethink communications to secure leadershipbuy-in.Talk the language of the business, focuson outcomes and benefits, and reframe the roleof the global regulatory team, not as a cost centerbut as a facilitator of competitive advantage andmarket access. 4Don’t forget to secure team buy-in, too.It’s notjust leadership that needs to be persuaded; it’s yourregulatory colleagues, too. To challenge culturalinertia (see point 1, above), you must make the casefor change and champion the transition to thefuture state. The insights and expertise shared on the followingpages are drawn from an IQVIA LinkedIn Live webinar,Accelerate Global Market Access with Confidence: HowAI-Enabled Regulatory Information Management (RIM)Transforms Compliance, which took place in February2026. The expertise comes from three thought leaders:Asheeta Anand, Director, Regulatory Affairs & QualityAssurance, Dentsply Sirona; Jeremy Yung, RegulatoryAffairs Director, Cynosure Lutronic; and Mike King,Senior Director, Product & Strategy, IQVIA. Theiropinions and their analysis of market, customer,and technology trends are reflected here. 5Approach AI with cautious optimism.RIM-focuseduse cases abound but don’t forget the human in theloop and the ability to explain AI decision making. 6Avoid the perils of siloed systems and embraceintegration.Assimilating RIM, quality managementsystem (QMS), and enterprise resource planning(ERP) data speeds regulatory submissions, minimizesongoing maintenance, and reduces the risk of error. The changing nature of globalregulation and compliancerewards agile minds andforward-thinking organizations. 7Remember, technology is an enabler.Ultimately,it’s the application of technology, not the technologyitself, which really matters. It’s there to help improveglobal healthcare outcomes and should be judgedon those terms. Global trends. Regional impact If we do not have a good understanding of regionalregulatory requirements, then it will affect market accesstimelines. For example, in India it takes 9 to 12 monthsto launch a product; in China it takes up to 24 months;and in Russia up to 24 months too, assuming all goesaccording to a realistic plan. Complexity, volume, and cost Take today’s economic headwinds and constraintsand add the potential impact of AI as well as industry-specific changes to global regulatory regimes designedto demonstrate the safety and efficacy of healthcareproducts. The result? An industry dealing with levelsof complexity never encountered before. The speedof change is unprecedented, too, with the scale of thechallenge affecting many global countries. Mike King:What are global regulatory teams looking toachieve? To optimize their go-to-market processes anddo so while navigating this complex environment in away that drives cost-effective compliance. This ultimatelyallows companies to bring critical healthcare solutions tomarket with predictable timelines. While the scale is global, for many organizations thespecifi