Regulatory Submissions: From IND to Market Authorization
BIOL-40401
This course provides a comprehensive overview of the regulatory pathways and submission processes for drugs and biologics from early development through market approval. Students will learn to prepare and submit Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and their global equivalents.
The course covers the structure, content, and technical requirements of regulatory submissions and the roles of key health authorities, including the FDA and EMA. Emphasis is placed on strategic planning, electronic submission standards (eCTD), and post-approval obligations.
What you'll learn
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Describe global regulatory pathways for drugs and biologics, including key development milestones from early clinical research through market approval and post-approval lifecycle management.
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Evaluate regulatory submission requirements for INDs, NDAs, BLAs, and global equivalents, differentiating between drug and biologic products.
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Apply regulatory strategy principles to support product development, optimize approval pathways, and align regulatory planning with scientific, clinical, and business objectives.
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Analyze the structure and content of regulatory submissions, including eCTD standards and lifecycle management of regulatory dossiers.
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Assess the roles and expectations of health authorities, such as the FDA and EMA, in the review, approval, and oversight of medicinal products.
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Integrate post-approval regulatory obligations into a comprehensive product lifecycle strategy, including change management, labeling updates, and compliance
Course Information
Course sessions
Section ID:
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
- No refunds after: 4/13/2026