Learn How to Prepare a REMS Assessment Report at our DIA Preconference Tutorial

REMS Assessment Report - DIA tutorial - UBC

Learn How to Prepare a REMS Assessment Report at our DIA Preconference Tutorial

Creating a REMS assessment report requires a high-functioning, coordinated team effort, often involving numerous departments and external vendors. UBC’s REMS experts have designed, implemented, and/or evaluated more than 100 RiskMAPS and REMS programs for drugs to treat everything from diabetes to organ transplant rejection.

At our DIA preconference tutorial, these experts will give you a roadmap to streamline report creation. We will identify the key milestones needed to create a REMS assessment report, tell you which teams need to be involved and review the sections and types of assessment reports. Attendees will learn how to:

  • Coordinate disparate sections such as the results of knowledge survey reports and adherence metrics
  • Integrate content dictated by the REMS and REMS approval letter
  • Determine data cut-off dates
  • Implement best practices for working with vendors
  • Handle survey design issues, such as comprehension testing
  • Deal with special concerns for shared REMS
  • Seek FDA input

Date & Time: Sunday, June 14 from 1:00 – 4:30 p.m.

Instructors:

Annette Stemhagen, DrPH,FISPE, Senior VP, Safety, Epidemiology, Registries & Risk Management, UBC

Catherine Sigler, DVM, PhD, MPH, Senior Director, Safety, Epidemiology, Registries & Risk Management, UBC

Matthew A. Lee, PharmD, Director, Regulatory Affairs, Marathon Pharmaceuticals, LLC