Kick Start DIA at our REMS Assessment Report Workshop

Kick Start DIA at our REMS Assessment Report Workshop

Creating a REMS assessment report requires a high-functioning, coordinated team effort, often involving numerous departments and external vendors. UBC’s REMS experience, including our work with REMS assessment reports, has played a significant role in the drug safety industry. UBC teams, made up of epidemiologists, safety scientists, data analysts, software developers, and patient educators, to name a few, have designed , implemented, and/or evaluated more than 100 RiskMAPS and REMS programs for drugs to treat everything from diabetes to organ transplant rejection.

Join us at DIA as our experts kick off the conference with a REMS Assessment Report Workshop that will give you a roadmap to streamline report creation, including:

  • Coordinating disparate sections such as the results of knowledge survey reports and adherence metrics
  • Integrating content dictated by the REMS and REMS approval letter
  • Determining data cut-off dates
  • Best practices for working with vendors
  • Handling survey design issues, such as comprehension testing
  • Dealing with special concerns for shared REMS
  • Seeking FDA input

Date & Time: Sunday, June 15 from 1:00 – 4:30 p.m.

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

Catherine Sigler, PhD,MPH, Senior Epidemiologist, UBC

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

Click here to register.