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Regulatory and medical writing is an integral part of the product development and approval process and plays a crucial role in assuring that submissions for new investigational products are well organized, accurate and reviewer-friendly.
This course provides an overview of the variety of investigational applications prepared by regulatory and medical writers for both drugs/biologics and medical devices. Key investigational submissions covered include region-specific applications for drugs/biologics such as the Investigational New Drug Application (IND), Canadian Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD), as well as those required for investigational devices such as the Investigational Device Exemption (IDE), European CTA and Investigational Testing Authorization (ITA). Participants will be introduced to the components of each of these application types and learn techniques for improving document quality in order to advance your career as a regulatory and medical writer.
At A Glance
Upon completion of this course, participants should be able to: