Risk Minimization and Communication: Scientific Approaches and Case Studies for Designing and Evaluating Interventions for the Safe Use of Medicines

‎1. Course Aim ‎

Risk minimization measures and risk communications are patient safety and public health interventions intended ‎to improve 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 aims to present ‎core concepts, established and new methods, and pragmatic approaches to conducting such research. Real world ‎case examples will be presented with experience from academia, regulatory bodies and the biopharmaceutical ‎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 case ‎examples. In addition, a senior regulator or regulatory advisor from the respective host country will offer an ‎overview and perspectives on current topics.‎

‎3. Course Objectives‎

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

Priya Bahri, RPh, DiplEpi, PhD
• Core concepts of risk minimisation, communication and stakeholder engagement 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

Peter Mol, PhD & Amir Sarayani PharmD MPH PhD
• Data and methods for designing and evaluating risk minimisation interventions involving patient and ‎healthcare professionals: ‎
• Primary data: survey, user-testing and qualitive study designs
• Secondary data: medicines utilisation study designs with interrupted time series analysis and ‎health outcome analysis

Meredith Y Smith, PhD MPA FISPE
• Using mixed methods approaches for formative and summative evaluations
• How to report evaluation results: Using the RIMES-SE checklist

Tania Schink, Dr.rer.medic. DiplStat
• How to design research for regulatory decisions on risk minimization interventions? - Overview and ‎perspectives on current topics from the EU ‎