Curriculum
The Master of Science in Regulatory Science and Digital Innovation (RSDI) at UCSF is a rigorous, interdisciplinary program that prepares students to lead in regulatory science amid rapid advances in digital health, artificial intelligence, and global biomedical innovation. The curriculum combines foundational regulatory knowledge with cutting-edge technical, ethical, and leadership training.
Two Program Tracks
The RSDI program combines advanced coursework with applied learning through either a master's thesis or capstone project, depending on track. Students select one of two tracks at admission:
| Executive Track | Foundational Track | |
|---|---|---|
| Format | Hybrid: Online with in-person sessions during the first week of each quarter | Full-Time, In-Person |
| Duration | 5 quarters | 4 quarters |
| Units | 41.5 | 54.5 |
| Audience | For mid- to senior-level professionals looking to gain expertise in the global regulatory landscape and policy. Applicants are recommended to have 5–10 years of experience in healthcare or industry as entrepreneurs, managers, and/or executives. | For students aiming for careers in industry and regulatory affairs, or early-career professionals looking to transition into industry and regulatory work. Applicants should have a strong interest in digital regulatory science and health technologies. |
| Curriculum | Culminates in a final master's thesis | Culminates in a capstone project |
Your Curriculum Journey
The elements of the program have been carefully crafted to educate regulatory affairs professionals not just for today but for the evolving landscape of tomorrow.
Program Highlights
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Regulatory Science and Policy
Fundamentals of Regulatory Affairs - Foundations of regulatory science, policy development, and regulatory decision-making
Global Regulatory Frameworks - Comparative analysis of U.S. and international regulatory systems and harmonization efforts
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Drug and Product Development
Drug R&D Processes and Regulatory Strategies - Regulatory pathways across the drug and device development lifecycle
Quality Assurance for Therapeutics - Quality systems, compliance, and lifecycle management for drugs, biologics, devices, and combination products
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Digital Health, Data, and AI
Digitization of Regulatory Workflows - Modern regulatory operations, digital submissions, and cloud-based data systems
Digital Data, SaMD, and Generative AI in Regulation - Regulation of software-based medical products and AI-driven technologies
Practical Modules of AI/ML for the Biotech Industry - Hands-on exposure to machine learning, predictive modeling, and data analytics
Real-World Data (RWD) and Real-World Evidence (RWE) Mining and Analysis (Foundational track)
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Ethics and Public Health
Ethics and Responsible Conduct of Research - Ethical frameworks for research, innovation, and regulatory decision-making.
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Introduction to Responsible Innovation
Social and Economic Determinants of Health Disparities - Regulatory decision-making through an equity and access lens
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Leadership, Entrepreneurship and Management
Entrepreneurship and Innovation - Business strategy, innovation pathways, and regulatory entrepreneurship
Leadership and Management (Executive track) - Leading teams and organizations in global regulatory environments
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Learning Experience and Support
Academic advising throughout the program
Faculty mentorship from leading experts in regulatory science, digital health, and policy
Workshops and case-based learning embedded across courses
Access to UCSF’s extensive research, computational, and industry networks
*Courses are pending university approval and subject to change
Executive Track Curriculum
The Executive Track consists of 41.5 units that are completed in five quarters.
| Quarter | Courses | Total units |
|---|---|---|
| Summer (July-Aug) | RSD 201: Fundamentals of Regulatory Affairs (5 units) RSD 202: Medical Product R&D Processes and Regulatory Strategies (3.5 units) | 8.5 units |
| Fall (Sept-Dec) | RSD 223A: Practical Modules of AI/ML for the Biotech Industry (2 units) RSD 203A: Global Regulatory Framework (2 units) RSD 220A: Introduction to Responsible Innovation (2 units) GS 214: Ethics and the Responsible Conduct of Research or a related course (2 units) | 8 units |
| Winter (Jan-Mar) | RSD 223B: Practical Modules of AI/ML for the Biotech Industry (2 units) RSD 204: Digitization of Regulatory Workflows (4 units) RSD 220B: Social and Economic Determinants of Health Disparities (2 units) | 8 units |
| Spring (Mar-May) | RSD 203B: Global Regulatory Framework (2 units) RSD 205: Entrepreneurship and Innovation (4 units) RSD 206: Quality Assurance for Therapeutics (3 units) | 9 units |
| Summer (June-July) | RSD 207: Digital Data, SaMD, and Generative AI in Regulation (4 units) RSD 208: Leadership and Management (4 units) | 8 units |
Foundational Track Curriculum
The Foundational Track consists of 54.5 units that are completed in four quarters.
| Quarter | Courses | Total units |
|---|---|---|
| Summer (July-Aug) | RSD 201: Fundamentals of Regulatory Affairs (5 units) RSD 202: Medical Product R&D Processes and Regulatory Strategies (4 units) RSD 203A: Global Regulatory Framework (2 units) RSD 204: Digitization of Regulatory Workflows (4 units) | 15 units |
| Fall (Sept-Dec) | RSD 223A: Practical Modules of AI/ML for the Biotech Industry RSD 203B: Global Regulatory Framework (2 units) RSD 205: Entrepreneurship and Innovation (4 units) RSD 206: Quality Assurance for Therapeutics (3 units) RSD 220A: Introduction to Responsible Innovation (2 units) | 13 units |
| Winter (Jan-Mar) | RSD 223B: Practical Modules of AI/ML for the Biotech Industry (2 units) RSD 207: Digital Data, SaMD, and Generative AI in Regulation (4 units) RSD 209A: Introduction to RSD Capstone Projects (3 units) RSD 220B: Social and Economic Determinants of Health Disparities (2 units) | 11 units |
| Spring (Mar-May) | CDD 206: RWD/RWE Mining and Analysis (4 units) GS 214: Ethics and the Responsible Conduct of Research or a related course (1.5 units) RSD 209B: RSD Capstone Projects (10 units) | 15.5 units |
*Courses subject to change