Regulatory Science
Graduate Certificate
Learn what goes into creating and developing medical products, along with the legal practices governing them, to make an impact in the biotech and pharmaceutical industry.
Program Overview
The 100% online Graduate Certificate in Regulatory Science:
- 12 credit units, with four courses at three credit units each, which can be completed in less than eight months
- Free to apply
- No admissions test required
- Units earned may be applied to a Master of Legal Studies degree
- You may take one course (three credit units) from any of the courses offered in the three other Graduate Certificates in Health Law, including Health Law for Health Professionals, Aging Law & Policy, and Health Information Privacy, Compliance, and Data Security.
There is a large and growing need for a well-trained regulatory science workforce to advance the translation of research into clinical interventions. This is why the University of Arizona James E. Rogers College of Law is collaborating with the Critical Path Institute (an organization created in partnership with the Food and Drug Administration) and the College of Pharmacy to offer a certificate, which was created designed by academic and industry leaders to cover real-world issues in regulatory science.
Relevant Coursework for Expertise Needed Today
All courses provide focused, individualized guidance and feedback as you progress through the program. Over the course of four courses (12 credits) you will:
- Learn how the FDA is structured and how it regulates drugs, biologics, devices and diagnostics
- Understand intellectual property and the role of patents in commercialization
- Explore incentives for medical product development and innovation
- Navigate the path from clinical trials to bringing a drug to market
Industry Experts Discuss Growing Need in the Workforce
"The multidisciplinary faculty designed a unique set of courses where students engage with the regulations governing the development, safety, and efficacy of medical products in the U.S. and abroad."
—Tara Sklar, JD, MPH, Professor of Health Law; Director of Health Law & Policy Program
“We often have to take a person with a hard science or clinical science background and train them up… There is a crying need for people with these skills to also have a basic understanding of how the regulatory approval process works... A training program like the Graduate Certificate in Regulatory Science at Arizona Law is really helpful to us.”
—Patrick O'Brien, JD, PharmD, General Counsel at Arrowhead Pharmaceuticals, Inc.
“We deeply value our relationship with Arizona Law’s Regulatory Science Program. It presents an opportunity for us to hire people right out of school who can hit the ground running.”
—Jeff Rothstein, JD, Vice President and Head of Legal Roche Tissue Diagnostics
This course explains the ethical principles underlying regulations and guidance governing clinical trials, especially as the principles pertain to informed consent, disclosure, and conflict of interest. The course also outlines the elements and design of clinical trials, including federal regulations for research with human subject participants, including vulnerable populations, and international research ethics. It concludes with the evolving role of research ethics in big data.
Better understand and navigate the drug development process, including the full range of drug regulation from discovery, innovative drug development tools, and the post-approval phase. The course includes the Food and Drug Administration and international regulatory perspectives on bringing drugs through clinical trials to market in the U.S. and abroad.
What are the fundamental incentives for development in the biomedical space? The topics covered in this course include introducing key concepts in oversight by the FDA, biologics and biosimilars, regulation of diagnostics, along with the medical device development and approval process. The course concludes with a survey of Intellectual Property rights governing medical products, and the regulatory challenges in international markets.
This course primarily focuses on the process of bringing medical devices from conceptualization to the bedside. There are a myriad of stakeholders and steps involved in this translational research process, which include: proof of concept, preclinical investigation, clinical application, regulatory assessment, reimbursement, and post-marketing evaluation. Ultimately, this course provides step-by-step explanations of the science, regulations, and reimbursement in medical device development, all with the aim to bring therapy to patients that improve survival and the quality of life.
This course is available to undergraduates as Law 488A.
How can a didactic regulatory science education be translated and applied to real world challenges? In this course, students will integrate and apply their knowledge of regulatory science to the challenges faced every day by industry and regulatory decision makers. Leaders in the field will present case-based scenarios, and students will work in teams to discuss and problem-solve historic, current, and emerging topics in regulatory science.
This course provides students with an overview of leadership and equity considerations in the life sciences industry. The business, legal and broader risk management concerns life science professionals must address to facilitate success in this complex and evolving industry are discussed. Relevant federal labor laws will be covered to provide a baseline legal framework that supports the need for diversity and equity in this global and growing industry.
This course is available to undergraduates as Law 475D.