Review the activities required to successfully prepare compliant electronic submissions for drug, biologic, and device registrations to health authorities in Europe, U.S., Canada, and Japan. This course will provide tools to enable implementation of in-house systems for producing electronic submissions or for managing projects outsourced to services vendors. It will identify the leading causes for agencies to reject electronic submissions, and the critical success factors to ensure that compliance and submission-readiness of content is built into the research and development process. This course will also cover the current electronic Common Technical Document (eCTD) format and highlight the Regulated Product Submission (RPS) format that is in development as follow-on to eCTD.
Course Number: BIOL-40260 Credit: 3 units