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#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

Tutorial name:
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

Day & Time:
June 14, 1:00PM - 4:30PM

Room Number:

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Risk evaluation and mitigation strategies (REMS) vary from simple to complex. Particularly for the complex Elements to Assure Safe Use (ETASU) REMS, data in the form of a REMS assessment report may greatly challenge team members as many may be new to the process. Creation of a REMS assessment report requires a high-functioning, coordinated and cooperative team (whether done all in-house or including vendors). During this tutorial, participants will discuss, and learn by role playing, key functional areas — data management, project writing, medical writing, pharmacovigilance, drug safety, epidemiology, and regulatory affairs with an emphasis on providing a timely, high-quality deliverable. Time will be spent on refinement of the project plan, development of the table of contents, and how to coordinate disparate sections such as knowledge survey reports and adherence metrics. Discussion will also focus on topics such as the content of the REMS assessment as dictated by the REMS and REMS approval letter, determination of data cut-off dates, working with vendors, what to include in the report regarding survey design issues such as comprehension testing, special concerns for shared REMS, and FDA input and timing.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Describe the key milestones needed to create a REMS assessment report;
• Identify who and how to engage in the multidisciplinary team required to create the report;
• Discuss the type of sections included in various types of REMS assessment reports.

Target Audience:
This tutorial is designed for professionals involved in clinical safety and pharmacovigilance.