Speakers: Meredith Y. Smith and Elaine Morrato
Description: Risk minimization programs are intended to support the benefit-risk balance of medicinal products, and recent regulatory
guidance requires that they be evaluated for effectiveness. Implementation Science is the study of methods that influence the
integration of evidence into practice, using social science theory and frameworks. Implementation Science can inform the
design and implementation of risk minimization programs to ensure that they are effectively disseminated across a range of
settings and patient populations. As a result, programs are more likely to achieve their goals for safe and appropriate use of
medicinal products while minimizing burden on the healthcare system. This presentation will address the design,
implementation and evaluation of risk minimization programs.
Goal: To present concepts from implementation science and state-of-the-art pragmatic approaches to improve risk
minimization program design and implementation. Objectives: 1) To recognize basic concepts and terms from Implementation
Science; 2) To examine how to pragmatically apply these concepts in program design, implementation and evaluation; 3) To
understand where to find key Implementation Science resources for further learning.