November 7, 2024
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Presentations
About This Course
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.
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 Covered
- 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
Resources
- REMS Logic Model: A Framework to Link Program Design With Assessment
- REMS@FDA website
- US Department of Health and Human Services, Centers for Disease Control and Prevention, Office of the Director, Office of Strategy and Innovation. Introduction to Program Evaluation for Public Health Programs: A Self-study Guide. Atlanta, GA: Centers for Disease Control and Prevention; October 2011
- U.S. Dept. of Health and Human Services, Public Health Service, National Institutes of Health, National Cancer Institute. Theory at a Glance: A Guide for Health Promotion Practice. Bethesda, MD; September 2005.
- Huynh L, Toyserkani GA, Morrato HE. Pragmatic Applications of Implementation Science Frameworks to Regulatory Science: An Assessment of FDA Risk Evaluation and Mitigation Strategies REMS (2014-2018). BMC Health Research Services. 2021 Aug 6;21(1):779. doi: 10.1186/s12913-021-06808-3. PMID: 34362367; PMCID: PMC8348874.