Danielle McVey
Danielle McVey is Director of Regulatory Innovation Culture Strategy and Enablement at Pfizer. Danielle is also Chair of TOPRA's Regulatory Operations (Reg Ops) Special Interest Network (SPIN)
JournalThe strategic role of Regulatory Operations in digital transformation success
This article discusses how Regulatory Operations is evolving from document-centric gatekeeper to data-driven strategic partner, and uses a case study from Syneos Health to show how its RegOps team led an initiative to deploy GenAI tools for patient narratives, CMC extraction and plain language summaries
CommentaryDeveloping a digital people strategy to harness the power of generative AI
Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks