Curriculum
- 16 Sections
- 60 Lessons
- 10 Weeks
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- Module 1: Introduction to Regulatory AffairsIntroduction This course provides an in-depth understanding of regulatory affairs, covering global regulations, compliance requirements, and the role of regulatory professionals in different industries.4
- Module 2: Drug Development and Approval Process4
- Module 3: Medical Devices Regulation4
- Module 4: Regulatory Affairs for Biotechnology and Biosimilars3
- Module 5: Global Regulatory Affairs4
- Module 6: Regulatory Submissions and Documentation3
- Module 7: Compliance and Risk Management3
- Module 8: Career Pathways in Regulatory Affairs3
- Module 1: Fundamentals of Regulatory OperationsThis course focuses on the operational aspects of regulatory affairs, including submission management, document control, compliance tracking, and the use of electronic systems for regulatory submissions.4
- Module 2: Regulatory Submissions and Document Management4
- Module 3: Electronic Regulatory Submissions (eCTD & Non-eCTD)4
- Module 4: Compliance and Regulatory Information Management4
- Module 5: Global Regulatory Operations4
- Module 6: Publishing and Submission Standards4
- Module 7: Regulatory Change Management and Post-Approval Operations4
- Module 8: Career Development in Regulatory Operations4
