Regulatory Science Graduate Certificate

Designed for graduate students and working professionals, the certificate program provides specialized training in navigating the path from research to bringing medical products to market. 

Specialized Training in Translating Clinical Research to Regulatory Science

Join an internationally-recognized, one-of-a-kind graduate program in Regulatory Science at the University of Arizona James E. Rogers College of Law in partnership with the UA College of Pharmacy. Designed for pharmaceutical and medical device professionals, policymakers, business leaders, scholars and current students, this certificate enables you to advance current practices in medical product development by learning the ethics, policies, and regulations at federal and global levels.

Relevant Coursework for the Expertise Needed Today

The unique coursework reflects a partnership with faculty experts and industry leaders to provide students with specialized training to lead innovation across medical products development. You will learn what goes into creating drugs, biologics or devices and the legal practices governing them to make an impact in the biotech and pharmaceutical industry.

All courses provide focused, individualized guidance and feedback as you progress through the program. Over the course of four 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

The 13-certificate credits can all be applied to the Master of Legal Studies

Prospective Students

This course is offered through UA Online. Current students as well as practicing healthcare professionals and alumni who have completed coursework are elgible to apply. 

Courses

Spring I (Jan-March) | Instructor: Mabel Crescioni, DrPH, JD, LLM, College of Public Health and College of Law
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.

Fall 1 (Aug-Oct) | Co-Instructors: John-Michael Sauer, PhD and Jennifer Burkey, PhD, C-Path and College of Law
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.

Spring 2 (March-May) | Instructor: Marco Schito, PhD, C-Path and College of Law
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 in international markets.

Fall 2 (Oct-Dec) | Instructor: Stephen Karpen, PharmD, C-Path and College of Law
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.  

Fall & Spring | Co-instructors: Leila Barraza, JD, MPH, College of Public Health and Elizabeth Hall Lipsy, JD, MPH, College of Pharmacy
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.

Online and On Your Terms

The flexible program is designed to be completed at your convenience and is 100% online. No entrance exam is required for admission.

Tuition

The cost is $650 per credit unit and excludes mandatory University fees.

Contact

Elizabeth Hall-Lipsy, JD, MPH
Program Manager, Health Disparities and Outreach
Assistant Professor, Pharmacy Practice and Science
ehall@pharmacy.arizona.edu
520-626-3180
Drachman Hall B207N