The Regulatory Affairs (RA) Certificate is a fully online program designed to develop learners’ knowledge and skills to bring safe, effective medical products to market. Graduates will be able to describe ways to maximize compliance and minimize risk in the development of FDA-regulated products and learn the foundation of science-based clinical investigation and corresponding regulations.
Successful applicants typically work in a regulatory affairs adjacent field and are seeking to understand regulatory affairs processes. The certificate is meant to be a standalone program.
Program Information
The certificate includes 4 full credit courses and is designed to take 16 months. The four courses consist of two core (required) courses and two regulatory affairs related electives. Students should plan to take one or two courses per term for consecutive terms.
Regulatory Affairs Certificate Study Plan
4 Credit Units
Fall
Spring
Summer
Fall
REG 5100: Intro to Clinical & Translational Research
Elective
REG 6100: Fundamentals of FDA Regulation
Elective
Please review the Regulatory Affairs Tuition webpage for details. Tuition and fees are charged per c.u. and the certificate program includes a total of 4 c.u. The program is not eligible for federal financial aid.
Applications are accepted during for the fall terms and should be submitted by May 1 for the following fall term.
ITMAT Education Faculty and Administration are glad to connect with interested applicants throughout the year. Through an initial consult, program faculty or staff can gain understanding to which program may best align with your career goals, connect to current students or faculty for additional insight, answer questions about the application process, and provide feedback on project proposals.
Contact us and a member of the team will reach out to set a time to discuss your interests.
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In addition, the Uniform Crime Reporting Act requires Pennsylvania colleges and universities to provide information related to security policies and procedures to students, employees and applicants; to provide certain crime statistics to students and employees; and to make those statistics available to applicants and prospective employees upon request.
You may request a paper copy of the report by calling the Office of the Vice President for Public Safety and Superintendent of Penn Police at 215-898-7515 or by emailing vp@publicsafety.upenn.edu.
Recognizing the challenges of teaching, learning, and assessing academic performance during the global COVID-19 pandemic, Penn’s admissions committees for graduate and professional programs will take the significant disruptions of the COVID-19 outbreak in 2020 into account when reviewing students’ transcripts and other admissions materials as part of their regular practice of performing individualized, holistic reviews of each applicant. In particular, as we review applications now and in the future, we will respect decisions regarding the adoption of Pass/Fail and other grading options during the period of COVID-19 disruptions. An applicant will not be adversely affected in the admissions process if their academic institution implemented a mandatory pass/fail (or similar) system for the term or if the applicant chose to participate in an optional pass/fail (or similar) system for the term. Penn’s longstanding commitment remains to admit graduate and professional student cohorts composed of outstanding individuals who demonstrate the resilience and aptitude to succeed in their academic pursuits.
The University of Pennsylvania is accredited, but there is no separate accreditation for regulatory affairs programs.
The Certificate in Regulatory Affairs program is offered by the University of Pennsylvania, an institution of higher education authorized to confer degrees and certificates conferring academic credit under applicable laws of the United States. Students who are interested in participating in the program from countries other than the United States are advised that each jurisdiction may have its own laws and regulations governing online educational programs, and some jurisdictions may not recognize course credit or an online degree awarded by the University as satisfying local requirements for professional licensure, employment qualification, or other purposes. Before enrolling in this program, prospective students should investigate their jurisdiction’s treatment of foreign online programs to ensure that participation in this program will meet their objectives.
The Certificate in Regulatory Affairs is a STEM OPT extension eligible program for holders of F-1 visas.
