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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment. The REMS Logic Model provides a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS Logic Model is to optimize REMS design and improve the way REMS are assessed by developing clear goals, objectives, and strategies that align with the intended outcomes of the REMS.

This activity is intended to provide an overview of the REMS Logic Model, including its methodological underpinnings and proposed use. An example of how the REMS Logic Model mapping tool can be used to visualize the relationship between design and evaluation will be provided.

There will be a Q&A session at the end of the session for the audience to ask questions.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals who design, implement and assess risk evaluation and mitigation strategies (REMS)
• NDA, ANDA, and BLA Applicants and Sponsors considering a REMS for a drug product
• Consultants and third-party vendors who assist with designing operational components to help implement and manage REMS requirements
• General public wanting a better understanding of REMS design, implementation and evaluation

TOPICS

• Genesis of the REMS Logic Model framework
• REMS design considerations regarding how to identify problem(s) associated with a serious risk that a REMS may be able to address and how to determine REMS goals
• REMS implementation considerations regarding development of an implementable program and identification of the data necessary to assess if the program is working as intended
• REMS evaluation considerations for determining desired health outcomes and assessment of the efficacy of the program
• An example of how to use the REMS Logic Model and the associated mapping tool

OBJECTIVES

• Explain the use of theories, frameworks, and logic models to assess the effectiveness of programs
• Discuss the potential value of a logic model in linking REMS design with assessment
• Describe the REMS logic model
• Apply the REMS logic model to a theoretical case

SPEAKERS

Suzanne Robottom, PharmD
Associate Director
Division of Risk Management (DRM) | Office of Surveillance and Epidemiology (OSE)
CDER | FDA

Victoria Sammarco, PharmD, MBA, BCPS, BCPPS
Risk Management Analyst
DRM | OSE | CDER | FDA

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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