**This session is part of the Skills Course Package add-on**

In this course, faculty will present and discuss considerations related to the study of selected outcomes that are often of interest when assessing the safety of medical products in pregnancy. The course will consist of four live remote presentations by faculty, each of them 20’-30’ long, and a live 30’-60’ Q&A session possibly with small discussion groups.

In 2015, the course provided an overview of issues that are particular to research on the safety of medical products in pregnancy. In 2016 the course focused on challenges related to exposure measurement, in 2017 the focus was on maternal and neonatal outcomes, and in 2018 the course presented pros and cons of various study designs. In 2019, the course discussed significance testing and analytical approaches to address biases. The content of the 2020 edition covered some of the main themes discussed in previous years. In 2021, we return to maternal and offspring outcomes, drawing from the most recent experiences of the presenters.

*This session is part of the Skills Course Package add-on
The course will start with a general overview on the safety of medical products in pregnancy, intended to provide context to the course and to be especially useful for first-time course attendees. This will be followed by more focused talks on various maternal and offspring outcomes, including long-term neurodevelopmental outcomes.

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Andrea Margulis, FISPE

RTI Health Solutions

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ICPE 2021 Sessions

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