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.
The 100% online Graduate Certificate in Regulatory Science:
- 13 credit units, with four courses at three credit units each, and one colloquium, 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 five courses (13 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
“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, risk-benefit disclosure, and conflicts of interest. The course also outlines the elements and design of clinical trials, including federal regulations for research with human subject participants, with vulnerable populations, and international research ethics. The course concludes with research ethics in big data.
This course navigates the drug development path stretching across the pre-clinical and post-marketing divide to cover the full range of drug regulation, including drug discovery, innovative drug development tools, and the post-approval phase. Intellectual Property protection and evaluation will be covered, along with FDA-enforced market exclusivity and FDA-expedited review programs. The course concludes with international regulatory perspectives, including the European Medicines Agency, the costs involved to bring drugs through the clinical trials to market in the US and abroad, and how this affects future investment and strategy.
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 Food and Drug Administration, biologics and biosimilars, regulation of diagnostics, along with the medical device development and approval process. Proving safety and efficacy in clinical development and promoting innovation through the adoption of new technologies and novel adaptive trial designs will also be discussed. The course concludes with a survey of Intellectual Property rights regime for medical products and the regulatory challenges international markets.
The course focuses on the process of bringing medical devices from conceptualization to the bedside. There are a myriad of stakeholders and steps involved that this course covers from industry and regulatory agencies through all phases of translational research: from proof of concept, to preclinical investigation, clinical application, regulatory assessment, reimbursement, and post-marketing evaluation. Ultimately, this course provides students with step-by-step explanations to enable a better understanding of the science, regulations, and reimbursement in medical product development with devices, all with the aim to bring therapy to patients that improves survival and the quality of life.
There are numerous needs in regulatory science that companies are faced with every day. This course provides an opportunity for students to integrate and apply their knowledge and skills to real-world challenges in regulatory science. Industry leaders will present case-based projects where students will work in teams to discuss and problem-solve multi-faceted issues on a current or emerging topic in regulatory science. Students will consult scientific priority areas and consider strategies for developing new tools and approaches for improvement of safety, efficacy, quality and performance of FDA-regulated products.
This course traces the historical evolution of policy and practice of patient access to investigational medical products prior to approval by the Food and Drug Administration. Students examine existing and emerging challenges such as therapeutic misconception, crowdfunding, real world data collection, and preapproval access to gene therapies.
This course explores the intersection of regulation and science, focusing on how regulators at federal and state levels can best accommodate science and how science can best be practiced to satisfy regulators. The course discusses the role of executive agencies such as the Food and Drug Administration (FDA) in ensuring safe and effective products to promote public health, different mechanisms executive agencies use to increase compliance, and current challenges for enforcement in a globalized world.
"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 Graduate Health Sciences Programs
"This program provides a background in how students and professionals can influence and directly participate in the field of Regulatory Science. In connection with our work at the Critical Path Institute, we provide students with the knowledge and tools to accelerate medical product development."
—John-Michael Sauer, PhD, Executive Director of the Predictive Safety Testing Consortium at the Critical Path Institute and Professor at University of Arizona