CTSI Now Offers Advanced Certificate in Regulatory Science

FDA food and drug administration approval health pharmacy certification

The CTSI, in partnership with the Department of Public Health Sciences, is rolling out a new advanced certificate in regulatory science for graduate students, postdocs, and researchers from a broad range of fields. The program is just one of several efforts by the CTSI to advance regulatory science and promote student and trainee interest in learning how new drugs and devices are developed and ultimately reviewed by the Food and Drug Administration (FDA).

The NYS-approved certificate, which is a graduate credential, requires 6 courses (totaling 13 credits) covering experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy. Students will also obtain at least 3 additional credits in an area of their choice, including options such as pharmacology, epidemiology, clinical trials, drug discovery, or scientific communication.

Beyond the course work, the certificate program offers mentorship and assistance in finding internships and shadowing experiences for regulatory science careers. Additionally, certificate students will participate in the annual “America’s Got Regulatory Science Talent” competition. Each year, the winner of the competition is given the opportunity to present their proposal to scientists and leaders at the FDA.

According to Scott Steele, Ph.D., associate professor of Public Health Sciences and program director for the certificate, “that exposure can give students a unique opportunity to engage leaders in this field and an advantage in identifying career paths – especially in industry or government”.

Steele believes the new regulatory science certificate program can help students with a broad range of career goals. Understanding the opportunities and challenges with medical product development and the FDA regulatory process is extremely valuable whether students plan to stay in academia or branch out into industry, government or other sectors.  This could include careers in research, policy, regulatory review, communications, program management and law.

Ultimately, the goal of regulatory science is to make the process of developing and approving new drugs and medical devices more efficient and ensuring that new, life-improving therapies can be properly and thoroughly evaluated as quickly as possible. Programs like the CTSI’s regulatory science certificate help by training scientists in the science, regulatory and policy issues involved in medical product development, creating a pipeline to the FDA, industry and other sectors.  This helps improve the efficiency and effectiveness of the translational research process by reducing the “ramp up time” for professionals in industry, academia and FDA and creating a scientifically trained workforce that is proficient in the science and policy issues that underlay the medical product development and approval process.

The certificate program applications are currently being processed for Spring 2017 but students, post-doctoral fellows, researchers and faculty can begin registering for required coursework this fall. The fall registration period for matriculated students at the University of Rochester School of Medicine and Dentistry opens July 1.

For more information and a full list of certificate requirements, click here.

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