Description
Essential Documents and Regulatory Submission is an online eLearning course that explains the key documents and regulatory processes involved in clinical research and drug development.
It covers Essential Documents, IND submissions, Clinical Study Reports (CSR), and New Drug Applications (NDA). Learners will understand the roles of sponsors, investigators, and ethics committees, along with regulatory requirements under global guidelines. The course also highlights inspection readiness, compliance, and proper documentation practices. By the end of the course, participants will have a clear understanding of how regulatory submissions support drug approval.
The program is made up of 1 module, 4 topics and 5 Quizzes.
On completing your enrolment for the Essential Documents and Regulatory Submission program you will instantly get access to our online learning portal.
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