Course
AI in Regulatory Sciences
Time limit: 100 days
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Full course description
Whether you're new to regulatory sciences or looking to understand the future of AI in human biotherapeutics, this course offers a practical and forward-looking foundation.
Course Overview:
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Module 1: Introduction to AI and Regulatory Sciences
Learn the fundamentals of AI and regulatory sciences, explore the concept of the AI-enabled ecosystem for human therapeutics, and examine emerging regulatory approaches for AI technologies. -
Module 2: AI in Drug Discovery
Understand how AI is reshaping preclinical research and early-stage discovery, including target identification, compound screening, and predictive modeling. -
Module 3: AI in Drug Development
Explore AI applications in clinical trials, including trial design, patient recruitment, data monitoring, and adaptive trial strategies. -
Module 4: AI in Drug Manufacturing
Study how AI supports drug manufacturing, from process optimization during development to ongoing quality control and supply chain integration. -
Module 5: AI in Regulatory Enabling Functions
Delve into how AI supports regulatory operations, pharmacovigilance, compliance, regulatory intelligence, and lifecycle management across the product journey. -
Module 6: Career Pathways in AI and Regulatory Sciences
Explore emerging roles and skillsets that align with the AI-enabled ecosystem and how you can prepare for opportunities in this evolving field.
Contact for assistance:
- Registration and payment: learnerservices@northeastern.edu
- General inquiries: RegSciAI@Northeastern.edu
- Technical support:
Primary: +1.617.373.4357 (HELP) Boston: +1.857.666.9306 London: +44.20.3318.2507

