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Sunday, June 26 • 1:00pm - 4:30pm
#33: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports

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Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

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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 workshop, participants will hear about relevant FDA regulations and guidances, recent status of REMS, and experiences in leading teams to successfully create REMS assessment reports. During hands-on activities, participants will receive case studies, discuss and role playing as 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.

Who should attend?

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

Learning Objectives

• 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.

avatar for Mark Ammann

Mark Ammann

President, Catalyst Regulatory Services, LLC
Mark A. Ammann is the owner and President of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Mark established and built a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided... Read More →
avatar for Catherine Sigler

Catherine Sigler

Executive Director, Safety, Epidemiology, Registries, and Risk Management (SERRM, UBC, An Express Scripts Company
Dr. Catherine Sigler is a Senior Epidemiologist and Executive Director in United BioSource Corporation (subsidiary of Express Scripts Inc.) department: Surveillance, Epidemiology, Registries and Risk Management (SERRM). She provides technical expertise in pharmaceutical safety issues... Read More →
avatar for Annette Stemhagen

Annette Stemhagen

Senior Vice President, Safety, Epidemiology, Registries & Risk Management, UBC, An Express Scripts Company
Dr. Stemhagen has more than 30 years of research experience, 20 yrs in safety surveillance. She has expertise in design, conduct, and analysis of peri-approval registries, LSS, actual use studies, including 35 regulatory-mandated safety studies. She has developed REMS for more than... Read More →

Sunday June 26, 2016 1:00pm - 4:30pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA