Medical Writing: Drugs, Biologics And Medical Devices License Applications

This course will provide an overview of various complex submission documents prepared by medical writers using common technical document/electronic common technical document (CTD/eCTD) used for the preparation and submission of premarketing applications of new products to the regulatory authorities of various countries such as US, EU, Japan, Canada, Australia and India. Crucial points, such as region-specific considerations for clinical sections in US New Drug Applications (NDA), US Biologics License Application (BLA) and EU Marketing Authorization Applications (MAA) will be discussed. The students will also learn about the two different types of primary premarketing submissions for medical devices, i.e. Premarket Notification application 510(K) and Premarket Approval (PMA). The students will be introduced to the different components of these submissions and different steps to follow in order to write regulatory applications to be submitted to FDA.

Fall, Spring

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