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Program Code:
BUN13
This bundle focuses on present REMS information in which communication tools have been shown to positively influence prescriber and patient knowledge. New, innovative approaches to communication round out this bundle for $299. The offering includes: New Ways to Learn What Happens to Patients AFTER Approval, Wrangling the Bestiary of Safety Documents: Coordination and Integration across Multiple Requirements, Use It Early and Often: Epidemiology’s Many Roles in Clinical Development and Beyond, Noninterventional Minimal Risk Research: A 360° Perspective, REMS: Are Our Written Communications Truly Mitigating Risks to Patients?, and Data Sources for Monitoring Usage of Drug Products and How to Use These Sources to Support Safety and REMS Evaluations.
Sessions included:
109 New Ways to Learn What Happens to Patients AFTER Approval
131 Wrangling the Bestiary of Safety Documents: Coordination and Integration across Multiple Requirements
171 Use It Early and Often: Epidemiology’s Many Roles in Clinical Development and Beyond
256 Noninterventional Minimal Risk Research: A 360° Perspective
342 REMS: Are Our Written Communications Truly Mitigating Risks to Patients?
366 Data Sources for Monitoring Usage of Drug Products and How to Use These Sources to Support Safety and REMS Evaluations