Risk Minimization and Communication: Science-based Approaches and Case Studies for Designing and Evaluating Effective Interventions for the Safe Use of Medicinal Products

Course Aim
Risk minimisation measures, including risk communications, are patient safety and public health interventions that are intended to impact the benefit-risk balance of medicinal products. Formative and evaluative assessment is needed to guide the design, evaluation and modification of such interventions within benefit-risk life-cycle management. This course is aimed at presenting core concepts and terminology, established and new methods, and pragmatic approaches to conducting such research purposefully and efficiently for optimising interventions. Real world case examples will be presented, and specific communication challenges emerging from the SARS-CoV-2 pandemic will also be discussed.

Requisites Statement
This is an all-level interactive course designed to expose attendees to the current state of the science and latest advances in research for designing and evaluating interventions for the safe use of medicinal products. There are no prerequisites for this course. The course materials are updated annually with the evolving science and current case examples.

Educational Objectives:
· Develop common and interdisciplinary understanding of concepts and terminology of risk communication, intervention design and implementation, and risk management sciences
· Develop understanding of pharmacoepidemiological, survey, patient preference and qualitative methods for formative and evaluative research into risk minimisation interventions
· Develop understanding of the integration of risk minimisation interventions into benefit-risk assessment and decision-making in the pre- and post-authorisation phases
· Develop understanding of how pharmacoepidemiology and benefit-risk management intersects with patient engagement

Syllabus Outline
· Priya Bahri, PhD - Core concepts of risk minimisation, communication and stakeholder engagement for benefit-risk management of medicines, illustrated by COVID-19 vaccine safety communication and other case examples
· Elaine H Morrato, DrPH MPH CPH - Implementation science theories and practice for benefit-risk management of medicines, illustrated by case examples
· Meredith Y Smith, PhD - Pragmatic application of implementation science to guide the program design and evaluation of risk minimisation interventions involving patient and healthcare professionals, including approaches to designing and testing risk communication tools, illustrated by a critical analysis of risk minimization approaches used for opioid analgesics
· Peter Mol, PhD - Combining drug utilisation study and survey methods for the evaluation of the impact of risk minimisation interventions on the use of medicines and patient safety outcomes, illustrated by case examples