Curriculum
At Cedars-Sinai we are dedicated not only to providing top-tier care, but also training the next generation of clinicians and industry leaders. As translational research continues to expand both in industry and medical settings, there is a growing need for researchers and staff who understand the regulatory processes required to advance scientific discoveries into product development and clinical trials. Our program seeks to address this need.
Certificate in Clinical and Regulatory Sciences
The Cedar-Sinai Certificate in Clinical and Regulatory Sciences provides industry, academic and clinical professionals with the knowledge and skills needed to engage in the regulatory field. This program focuses not only on learning the basics of clinical and regulatory sciences, but also real-world application of these concepts.
Offered virtually, the certificate program is available to professionals and students across the country to build a cohort with diverse perspectives and expertise. Through an engaging online educational framework and monthly Q&A sessions, students will experience a variety of learning environments, ensuring they are equipped with the valuable skills necessary for success upon completion.
The certificate program is designed to be completed in one year, with three required courses:
- CRS 601: Regulation of Pharmaceuticals, Biologics, and Medical Devices
- CRS 602: Foundations of Clinical Trials
- CRS 603: Next Generation Regulatory Topics
Winter Trimester 1 (January–April)
Course: Regulation of Pharmaceuticals, Biologics, and Medical Devices
Regulation of Pharmaceuticals, Biologics, and Medical Devices provides a comprehensive introduction to the regulatory landscape and developments processes for medical products in the United States. It spans the full product lifecycle, from initial discovery and development through the regulatory approval and post-market quality assurance across various pathways. The topics offered through this program will equip professionals with the essential tools and knowledge to navigate the complex intersection of regulations, science, and law when developing products and bringing them to the market.
Topics covered in this course includes:
- Overview of regulatory pathways: drugs, biologics, and medical devices
- Overview of Drug Discovery
- Fundamentals of the FDA Regulatory Process for Drugs, Biologics, and Medical Devices
- Development of Novel Therapies
- A Beginner’s Guide to Chemistry, Manufacturing, and Controls
- Introduction to the American Legal System for Medical Product Professionals
- Quality Assurance for Drugs, Biologics, and Medical Devices
Summer Trimester 2 (June–July)
Course: Foundations of Clinical Trials
Foundations of Clinical Trials provides students with a foundational understanding of clinical research. It covers an introduction to the design and conduct of clinical trials, including study design, informed consent, participant recruitment and interactions with the Institutional Review Board (IRB). Foundational statistical concepts relevant to clinical research are introduced alongside best practices in data collection and quality control. The legal framework surrounding medical products in the United States is explored to provide students with real-world examples and view of both scientific and regulatory responsibilities.
Topics covered in this course include:
- Introduction to Clinical Trials
- Informed Consent, Participant Identification and Recruitment, and Working with the IRB
- Introduction to statistical concepts for basic and clinical research and survival analysis
- Data Collection and Quality Control
- American Legal System and Medical Products
Fall Trimester 3 (October–November)
Course: Next Generation Regulatory Topics
Next Generation Regulatory Topics explores the evolving landscape of the pharmaceutical and healthcare industries, covering topics on emerging technologies and regulatory considerations. Real-world examples are provided to examine how the areas listed below may generate transformative impact on automation and decision-making with regulatory insights.
Topics covered in this course include:
- Emerging Innovative Technologies in the Pharmaceutical Industry
- Real-World Evidence
- Digital Therapeutics and Regulations
- Curative Therapies and Manufacturing
- Cosmetics
- Artificial Intelligence and Precision Medicine
Note: Curriculum and schedule may be modified at the discretion of the institution.
Have Questions or Need Help?
If you have questions or wish to learn more about the Clinical and Regulatory Sciences Certificate Program, please contact:
700 N. San Vicente Blvd., Pacific Design Center, STE G500
Los Angeles CA, 90069