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
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
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
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)
Ethics and Public Health
Ethics and Responsible Conduct of Research - Ethical frameworks for research, innovation, and regulatory decision-making.
Introduction to Responsible Innovation
Social and Economic Determinants of Health Disparities - Regulatory decision-making through an equity and access lens
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
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