Jacci Squire
JaJacci Squire is the Director of Publishing at Syneos Health. Jacci is a member 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
FocusHow data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.