UA Colleges of Pharmacy and Law, Critical Path Institute Offer Online Graduate Certificate Program in Regulatory Science

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.
"We are committed to provide more options for students and professionals to market themselves within targeted areas where specific expertise, such as regulatory science, is needed."

The University of Arizona and the Critical Path Institute have launched a new online graduate certificate program designed to equip students and working professionals across multiple disciplines with core competencies in regulatory science. Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all products regulated by the U.S. Food and Drug Administration.

“There is a large and growing need for current and future pharmaceutical and medical device professionals, regulators, business leaders and scientists to have specialized training in translating research into new interventions for safe and effective medical products,” said Tara Sklar, JD, MPH, director of the Graduate Certificate in Regulatory Science and professor with the UA James E. Rogers College of Law.

The Graduate Certificate in Regulatory Science program is offered through University of Arizona Law in partnership with the UA College of Pharmacy and the Critical Path Institute (C-Path). The program is accepting applications for courses that will begin in January 2019.

“This program provides a background for graduate students and professionals to influence and directly participate in the field of regulatory science,” said John-Michael Sauer, PhD, executive director of the Predictive Safety Testing Consortium at C-Path and pharmacology professor at the UA College of Medicine – Tucson. “In connection with our work at the Critical Path Institute, we provide students the knowledge and tools to accelerate medical product development.”

Describing the core competencies in the program, Christopher Robertson, JD, PhD, associate dean for research and innovation and professor with UA Law said, “Students will gain specific insight into how the U.S. Food and Drug Administration is structured and how it regulates drugs, biologics, devices and diagnostics, from early discovery and development to bringing products to market. Courses feature an in-depth and educational focus on policies, ethics, regulations and processes covering basic science work, pre-clinical trials and post-marketing responsibilities.”

“All five of the courses are developed by academics from law and the health sciences, along with industry leaders to ensure there is direct application from what is taught to what is needed in the regulatory science workforce,” said Sklar. “Students will be able to complete the coursework within a year and all credits may be applied to a Master of Legal Studies degree.”

The certificate is one of several new offerings in the UA College of Pharmacy aimed at expanding and refining skills for students enrolled in a health sciences graduate program and for practicing professionals.

“We are committed to provide more options for students and professionals to market themselves within targeted areas where specific expertise, such as regulatory science, is needed,” said Rick G. Schnellmann, PhD, dean of the UA College of Pharmacy.

For more information, or to apply, visit the Graduate Certificate in Regulatory Science program, or email law-health@email.arizona.eduDeadline for applications is Dec. 15, 2018.