Sidley Healthcare partner Meena Datta will moderate two panels related to enforcement and compliance at Hub and Specialty Pharmacy Models West.
“Explore Evolving Regulatory Reform in the Patient Support Services and Hub Models Landscape” will provide a comprehensive understanding of the existing regulatory landscape governing patient support services and hub models, including OIG guidelines, compliance standards and industry best practices. Attendees will gain valuable insights into the latest enforcement actions and the ramifications of recent cases and uncover the top areas of focus for 2025 and 2026.
“Clinical Research Compliance – Ensuring Ethical Clinical Investigator Interactions” will discuss how attendees can establish and maintain compliant investigator relationships and navigate fair market value (FMV) determinations, contract negotiation, and transparency in transfers of value; delve into regulatory expectations for investigator interactions to understand and implement optimal guidelines for communication, data integrity, and conflict of interest management in clinical trials for both pre-approval and post-approval companies; and discuss how to implement effective oversight and monitoring of investigator activities and discuss best practices for documentation, audits, and addressing potential compliance risks throughout the trial lifecycle.
