Regulatory Submissions, Information, and Document Management Forum

As regulatory agencies implement structured, modular, and digital-first requirements, leading pharmaceutical organizations are confronting unprecedented regulatory convergence. Initiatives such as ICH M4Q(R2), CDISC USDM, ICH M11, and ePI are reshaping content creation, more as data, across clinical, CMC, and labeling domains—demanding both operational and organizational transformation. This session will have transformation leaders from multiple pharmaceutical companies and providers to share how they are designing future-state operating models, building scalable governance for cross-functional content collaboration, sequencing technology implementation for maximum impact, and overcoming organizational resistance to digital transformation. Attendees will hear from organizations at varying stages of adoption, from early pilots to mature programs. This collaborative session provides actionable strategies for pharmaceutical leaders building comprehensive digital content ecosystems that position their organizations for regulatory modernization initiatives including FDA KASA requirements, EMA SPOR implementation, and emerging global harmonization standards driving the future of pharmaceutical operations. Speakers will share practical insights on establishing Centers of Excellence, managing change across regulatory affairs, clinical operations, and manufacturing quality teams, while addressing technical challenges including enterprise system integration and metadata standardization.