Regulatory Pharmacoepidemiology

We will engage the course participants in an interactive learning about key aspects of pharmacoepidemiology from a point of view of a regulator. Specific attention will be given to uniqueness of the state of the science in drugs-, devices- and biologics- epidemiology including current differences/potential for convergence in the international regulatory setting. The session is constructed as a dynamic combination of a didactic and a hands-on work in order to maximize the learnings, knowledge retention and networking among participants. Dr. Gerald Dal Pan will discuss the topics of benefit-risk in the regulatory context, types of evidentiary standards used in drug regulations and role pharmacoepidemiology plays in regulatory determinations. Dr. Marinac-Dabic will discuss the medical device epidemiology and its role throughout the entire device lifecycle, real-world evidence generation, synthesis and appraisal, methodological intersection between epidemiology and data science, and the role of digital health tools in modernizing device surveillance efforts. Dr. Donegan will focus on the challenges in the current pharmaco-epidemiology, regulatory epidemiology through the COVID-19 pandemics and the global regulatory intersections. Following the didactic part of the course the participants will engage interactively in a series of test cases facilitated by the faculty. Finally, the participants will be given opportunity to shape up the next year course by sharing their ideas about the content and format.