SC-19 - Risk Minimisation and Communication: Pharmacoepidemiological Approaches and Case Studies for Designing and Evaluating Interventions for the Safe Use of Medicines

1. Course Aim
Risk minimisation measures (RMM)/risk evaluation and mitigation strategies (REMS) and risk communications are patient safety and public health interventions that aim at improving the benefit-risk balance of medicinal products. Formative and summative evaluative research is needed to guide the design, implementation and evaluation of such interventions. This course will present both established as well as innovative concepts and methods, and pragmatic approaches to conducting such research with real world case examples. Experts from academia, regulatory bodies and the biopharmaceutical industry will discuss current challenges and good practices in risk minimization and communication, thus offering course attendees a unique, multi-stakeholder learning experience.

2. Requisites Statement
This is an all-level interactive course designed to expose attendees to the current state of the science and regulatory policy, and the latest advances in research for designing, implementing and evaluating interventions for the safe use of medicinal products. There are no prerequisites for this course. The course content and materials and case examples are updated annually. In addition, a senior regulator, regulatory advisor or other specialist from the respective host country is invited each year to offer a local perspective on the policy and practice of risk minimization.

3. Course Objectives

Educational Objectives:
• To gain familiarity with key concepts and terminology of risk minimisation and communication, intervention design, implementation and evaluation.
• To become conversant with pharmacoepidemiological, survey and qualitative methods for formative and summative evaluation of risk minimisation programs.
• To learn how to integrate such research findings into benefit-risk assessment and decision-making in the pre- and post-authorisation phases.
• To understand how pharmacoepidemiology and benefit-risk management intersects with patient engagement.
4. Syllabus Outline

Course Leads: Priya Bahri, RPh DiplEpi PhD FISoP & Meredith Smith PhD MPA FISPE


Introduction: Medicines development and the BRACE cycle, and course overview (Meredith Smith)

Presentations:

Meredith Smith PhD MPA FISPE (on behalf of Priya Bahri)
• Concepts of risk minimisation and communication, stakeholder engagement and pharmacoepidemiological literacy for benefit-risk management of medicines

Elaine H Morrato, DrPH MPH CPH FISPE
• Implementation science theories, models and practice for benefit-risk management of medicines

Amir Sarayani PharmD MPH PhD
• 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

Katie Miller (guest speaker)
• Tools and strategies for purposeful formative surveys prior to finalizing and implementating risk minimisation measures.

Meredith Y Smith PhD MPA FISPE
• Mixed methods approaches for formative and summative evaluations
• Reporting evaluation results based on the RIMES-SE checklist