Distinguished Professor University of Florida, Pharmaceutical Outcomes & Policy, Center for Drug Evaluation & Safety Gainesville, United States
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