Ritchey ME, Alhambra DP, Mack C, Lystig T, Anderson-Smits C. Medical device epidemiology. Presented at the 35th Annual ICPE Conference; August 25, 2019. Philadelphia, PA. Previously presented at the 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE).

Over the past few years, there has been increased focus on generating real-world evidence for medical products. Thus, medical product epidemiology is gaining visibility outside of ISPE. Medical device epidemiology uses methodologies similar to those for medicines. However, alternative strategies are often implemented due to the nature of the products, data sources, and situational use. With the changing regulatory and reimbursement environments, it is more important than ever for pharmacoepidemiology researchers to better understand the methods and practice of medical device epidemiology, both for study of medical devices and combination products. Methods discussed will be applicable across therapeutic products will provide deeper understanding of measuring benefits and risks in clinical context.

This course provides a foundation for medical device epidemiology and its current applications in actual clinical practice. It will comprise of a 4-hour session that will incorporate didactic lectures and interactive case studies that highlight novel medical devices and combination products.

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