Graduate Certificate in Regulatory Science
There is a large and growing need for a well-trained regulatory science workforce to advance the translation of research into clinical interventions. That’s why C-Path is participating in the development of this interprofessional graduate certificate program conceived in collaboration with industry leaders in regulatory science, along with University of Arizona academics across the Colleges of Law, Pharmacy, Public Health, and Medicine. The curriculum is designed to equip students and working professionals across multiple disciplines with basic competencies in regulatory science.
The certificate competencies cover policies, ethics, and processes, including pre-clinical studies to post-marketing responsibilities. This specialized training will uniquely prepare graduates to facilitate and lead innovation across medical product development. Graduates of the program will be able to advance their careers with this training, or transition into the regulatory science field or related discipline.
Translating basic research to meet regulatory requirements for medical product development
Join an internationally-recognized, one-of-a-kind graduate program in Regulatory Science at the University of Arizona James E. Rogers College of Law. Designed for pharmaceutical and medical device professionals, policy makers, 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 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 product development. Students will learn what goes into creating drugs, biologics or devices and the legal and regulatory principles governing them, to make an impact in the biotech and pharmaceutical industry.
Online. On your terms
In as few as 12 months, advance your career in the Regulatory Science field. The flexible program is designed to be completed at your convenience and is 100% online. There is no entrance exam, and all of the courses offer focused, individualized guidance and feedback, as students’ progress through the program. The 12-certificate credits can all be applied to the Master of Legal Studies.
“When the FDA launched the Critical Path Initiative and provided support to the Critical Path Institute in 2005, everyone recognized the need for a forum for regulatory science but few of us could have anticipated the many successes that have resulted. The new Certificate Program at the James E. Rogers College of Law is validation that regulatory science has emerged to become an integral sub-discipline in biomedical education and an exciting new career opportunity.”
— Raymond L. Woosley, MD, PhD
C-Path Founder
C-Path Instructed Courses:
Law 576A: Drug Discovery, Development & Innovation to Reach the Marketplace
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.
Law 589A: Emerging Trends in Regulatory Science
How can a didactic regulatory science education be translated and applied to real-world challenges? In this course, students gain a foundational understanding of regulatory science concepts and will independently integrate and apply this knowledge to the complex issues faced by industry and regulatory decision-makers. Through a series of case-based scenarios, students will analyze historic, current, and emerging topics in regulatory science. Emphasis is placed on individual critical thinking and problem-solving, providing each student the opportunity to engage deeply with the material and demonstrate independent application of regulatory concepts.
For more information, check out the University of Arizona Website here.
