Jalbert J, Prieto Alhambra D, Mack C, Canos D, Ritchey ME, Holy C, Etler K. Medical devices epidemiology. Presented at the 33rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE); August 27, 2017. Montreal, Canada.


Over the past few years, there has been increased focus on “real-world evidence.” Thus, epidemiology of therapeutic products is gaining visibility outside of ISPE. Medical device epidemiology uses methodologies similar to those seen with 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 all pharmacoepidemiology researchers to better understand the world of medical device epidemiology. The nuances of methods may be applicable to other therapeutic products, the data sources may provide deeper understanding of benefits and risks in clinical context, and honestly, its exciting stuff. This course provides a foundation for medical device epidemiology and its current applications in the real world. 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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