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Certificate Program in Regulatory Affairs
Below this overview, you will find a list of all the courses associated with this program. While not all courses are currently offered, you can view each course description to become more familiar with the complete curriculum of the certificate or award.
Certificate Contact
Applied and Natural Sciences Department, (408) 861-3860, or e-mail program@ucsc-extension.edu.
Program Overview
Regulatory affairs professionals play critical roles in ensuring compliance with the laws and regulations guiding the development and commercialization of health care products. As Bay Area bioscience companies grow and mature, their need for trained regulatory personnel intensifies. Recent industry studies cite regulatory affairs as one of the most crucial human resource needs in the coming decade. However, there are currently few options available in our region for formal, in-depth training for the early-stage regulatory professionals to fill the pipeline.
The Regulatory Affairs Certificate has been developed, under the guidance of industry and government experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry. Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.
Certificate Requirements
To obtain the Certificate in Regulatory Affairs, students must complete the seven required courses and four units of elective courses , for a minimum total of 19 units . In order to be eligible for this certificate, you must (1) complete all course work within three years of filing the application to establish candidacy, and (2) achieve an overall 3.0 grade point average (GPA) for all required and elective courses (no course grade lower than a C minus). In addition, all courses applying toward the certificate must have been successfully completed within five years of the date on which the certificate is issued. Please go to www.ucsc-extension.edu/gpa for our GPA calculator to calculate your grade point average. Students who complete a certificate program with a GPA of 4.0 will earn a Certificate with Honors.
Students pursuing both the Regulatory Affairs and Biotechnology or Clinical Trials Design and Management certificates need a minimum of 32 units, including all required courses and elective units for both programs. Please note that in order to complete two certificate programs with the minimum number of units, students must select some electives that are common to both programs. Please contact us at program@ucsc-extension.edu or call (408) 861-3860 if you need more information or would like assistance creating a study plan.
Courses may be taken individually or as part of the certificate program.
Prerequisites
Given the scientific foundations of the bioscience industry and the importance of effective communication to the regulatory role, students who come to the program with a basic understanding of the life sciences and strong written and oral communication skills will most benefit from this program.
Recommended Course Sequence
We recommend that students begin the program with "Drug Development Process" followed by "Regulation of Drugs and Biologics," or "Regulation of Medical Devices and Diagnostics."
Required Courses (Seven)
Drug Development Process (2 units)
Regulation of Medical Devices and Diagnostics (3 units)
Regulation of Drugs and Biologics (3 units)
One of the following:
Regulatory Submissions: Drugs and Biologics (2 units) OR
Regulatory Submissions: Devices and Diagnostics (2.5 units)
One of the following:
Good Manufacturing Practices (3 units) OR
Regulatory Compliance for Medical Devices (2.5 units)
Interacting with the FDA (1.5 units)
RA Professional's Tool Box (1.5 units)
*Students interested in taking submissions or compliance courses in both device and drugs/biologics areas can use the second such course as an elective.
Elective Courses (4 units required)
See below for electives
Certificate Application Information
We encourage you to establish candidacy in a certificate program early in your studies. The benefits of declaring candidacy early include notification of updates to the program. Certificate applications can be submitted through our online form or using our PDF form . If you use our PDF form, please submit your application along with the appropriate fee to the address or fax number listed on the application form.
Once the requirements of the certificate have been met, students must contact our office at program@ucsc-extension.edu to request their certificate.
Transferring Credit From Other Schools
Subject to departmental approval, students may substitute one equivalent course from another institution for one in the certificate program. The course must have been taken within the past five years with a grade of C or better, cover the same material as the required course, carry equivalent or more credit, and be from an accredited academic institution.
To be considered, obtain a " Substitution Request Form " from our Web site and send your request along with a course outline and description, and transcript to Applied and Natural Sciences as indicated on the form.
ACRP Contact Hours
Many of the required and elective courses in UCSC Extension's Clinical Trials Certificate Program qualify to provide contact hours toward ACRP recertification. See the Association of Clinical Research Professionals Web site at acrpnet.org for certification information.
BRN: Board of Registered Nursing
All courses designated BRN are approved for continuing education hours for RNs and LVNs (Provider# CEP13114).
RAPS Credit
Many courses qualify for points toward recertification for RAC. See the Regulatory Affairs Professionals Society Web site at raps.org for details.
