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

‎1. Course Aim ‎
Risk minimisation measures and 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 with experience from academia, regulatory bodies and ‎pharmaceutical industry. ‎

‎2. 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. In addition, a senior regulator from the respective host country will offer an overview and ‎perspectives on current topics.‎

‎3. Course Objectives‎

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
‎4. Syllabus Outline‎
Priya Bahri, PhD
• Core concepts of risk minimisation, communication and stakeholder engagement for benefit-risk ‎management of medicines – Regulatory perspective and needs for patient safety (Priya)‎
Elaine H Morrato, DrPH MPH CPH
• Implementation science theories, models and practice for benefit-risk management of medicines
Peter Mol, PhD, Meredith Y Smith, PhD & Amir Sarayani
• Data and methods for designing and evaluating risk minimisation interventions involving patient and ‎healthcare professionals: ‎
o Primary data: survey, user testing and qualitive study designs
o Secondary data: medicines utilisation study designs with interrupted time series analysis and ‎health outcome analysis
o Mixed methods
o Quality of study reports: RIMES checklist
Rania Mouchantaf, PhD
• Regulatory decisions on additional risk minimisation interventions – Overview and perspectives on ‎current topics from Health Canada