Graduate Certificate Programs in Regulatory Affairs and Regulatory Science
Regulatory affairs graduate certificate programs provide qualified students and mid-career professionals who hold at least a bachelor’s degree with relatively direct access to academic training in the laws, regulations, and quality assurance standards governing the development, testing, manufacturing, and marketing of medical products (pharmaceuticals, biologics, medical devices). These programs consist of several graduate level courses that prepare students for regulatory compliance responsibilities and other related work in the pharmaceutical and medical device industries.
Most graduate certificate programs require three to five master’s-level courses that can typically be completed in six to 12 months (although some programs are designed to be completed in two years). Thus, qualified students can earn a graduate certificate and be ready to enter the regulatory affairs workforce in less than half the time it would take to complete a full master’s degree program in regulatory affairs. Students who decide to pursue a master’s in regulatory affairs after completing a graduate certificate program are generally able to apply some, if not all, of their certificate program credits to an eventual master’s degree, as certificate coursework commonly overlaps with master’s program curricula.
Regulatory Affairs Explained
The process by which pharmaceuticals, medical devices, and many medicinal dietary supplements are developed, tested, and brought to market is subject to regulation from the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union, and other regional and national organizations, many of which are affiliates of the International Coalition of Medicines Regulatory Authorities (ICMRA). Failure to comply with national and international regulations and breakdowns in regulatory compliance pose a threat to public health and may lead to costly delays in getting a product to market, fines, and other penalties, and, in serious cases of malfeasance, criminal prosecutions. Thus, compliance with federal and international regulations governing healthcare products, as well as with any relevant state statutes that apply to laboratory research and manufacturing safety, is an integral part of doing business in this sphere and a vital concern for companies engaged in pharmaceutical and/or medical device research, development, and production.
Regulatory affairs encompasses all of the issues and concerns related to regulatory compliance, from understanding relevant laws and statutes regarding the healthcare products industry, to overseeing and documenting the processes by which companies ensure adherence to federal and/or international standards and guidelines. Professionals in the field of regulatory affairs, which include regulatory affairs specialists, associates, and managers; quality control professionals; and compliance officers, require a working knowledge of the various healthcare products subject to federal and international regulation (biologics, cosmetics, dietary supplements, pharmaceuticals, and medical devices), deep familiarity with the regulatory environment and regulatory agencies, and a clear understanding of regulatory protocols and processes. The Organization for Professionals in Regulatory Affairs (TOPRA), an international member group of regulatory professionals, highlights six primary responsibilities for healthcare regulatory professionals:
- Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products.
- Advising on legal and scientific restraints and requirements.
- Collecting, collating, and evaluating scientific data.
- Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned.
- Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
- Helping the company avoid problems caused by poorly kept records, inappropriate scientific thinking, or poor presentation of data.
These responsibilities may be delegated among a team of regulatory professionals at larger companies and commonly overlap with the concerns of clinical research managers, quality control and risk management officers, marketing directors, and others involved in overseeing the development, manufacture, distribution, and marketing of healthcare products. Thus, regulatory affairs is a distinct yet integral function within the research, development, production, and marketing of pharmaceuticals, medical devices, and other healthcare products.
Identifying and Classifying Regulatory Affairs Graduate Certificate Programs
To be classified as a graduate certificate, a program must be designed for students who have already completed their bachelor’s degree and are thus prepared to begin their graduate studies, and it must consist of a limited number of courses that focus on a narrow band of academic and/or professional studies. Regulatory affairs graduate certificates are programs of this type that provide training and instruction in the laws and regulations governing the healthcare products industry and the process by which regulatory compliance is assured. These programs are offered by accredited colleges and universities, typically through schools of health, law, medicine, pharmacy, and professional studies. They are generally comprised of no more than six required and/or elective courses, some or all of which may be part of a master’s in regulatory affairs program curriculum.
While many programs are formally designated as Regulatory Affairs Graduate Certificate programs, there is some variation in the naming of these programs. Graduate certificate programs may be referred to as post-baccalaureate certificate programs or advanced certificate programs. In addition, there are post-master’s graduate certificate programs, which are graduate certificate programs that are designed specifically for students who already hold a master’s or doctoral degree. As is evident from their name, post-master’s certificate programs require at least a master’s degree for admission.
Graduate certificate programs in regulatory science, pharmaceutical and/or medical device compliance, pharmaceutical and/or medical device law and compliance, and biopharmaceutical/biotechnology/drug development/medical device regulatory affairs can all be classified as regulatory affairs graduate certificate programs, provided they prepare graduate students for work in the field of regulatory oversight and compliance. Examples of titles for graduate certificates in regulatory affairs that prospective students might find include but are not limited to:
- Graduate Certificate in Regulatory Science
- Post-Baccalaureate Certificate in Regulatory Science
- Graduate Certificate in Pharmaceutical and Medical Device Regulatory Compliance
- Graduate Certificate in Biopharmaceutical Regulatory Affairs
- Graduate Certificate in Medical Device Regulatory Affairs
- Global Regulatory Affairs in Drug Development Graduate Certificate
- Post-Master’s Certificate in Advanced Regulatory Affairs and Quality Assurance
Note: The Regulatory Affairs Professionals Society (RAPS) also offers an online Regulatory Affairs Certificate Program that professionals can pursue directly from RAPS. However, this is not a graduate certificate program taught at an accredited college or university and does not confer students with graduate credits. RAPS also offers a professional certification, the Regulatory Affairs Certification (RAC), which some employers may prefer or require depending on the position.
Regulatory Affairs Graduate Certificate Courses
Specific course requirements for a graduate certificate in regulatory affairs vary by school and by the focus of particular programs. Some programs have a set cluster of courses that graduate certificate students are required to complete, while others allow students to choose from among a number of different electives in order to align the training they receive with their interests and career goals. However, most programs require students to take one or two core courses that provide an overview of how pharmaceuticals and medical devices are developed, tested, and approved for use and the federal and international laws and regulations that govern this process. In addition, students in a regulatory affairs graduate certificate program commonly take courses in the following topics:
- Biostatistics Translational Research
- Compliance Skills: Auditing, Investigation, & Reporting
- Food and Drug Law
- Industrial Approaches to Drug Discovery
- Quality Assurance for Drugs & Biologics
- Regulatory Device Diagnostics
- Structure & Management of Clinical Trials
Online Graduate Certificate Programs in Regulatory Affairs
Many accredited colleges and universities now use distance-learning technologies to offer graduate certificate programs via online instruction in order to accommodate students who have full-time jobs and/or cannot easily commute to a school’s campus for in-person classes. In fact, there are a number of schools that offer fully online graduate certificate programs in regulatory affairs. These programs provide the same training and instruction as their campus-based counterparts but do so without requiring students to attend campus-based classes. Instead, students in an online program log on to a school’s learning management system (LMS) for live and/or prerecorded lectures. These virtual classes may take place in real-time (synchronous instruction), requiring students to be logged on to the school’s LMS at specified times, or they may be delivered asynchronously, which means students can access the instructional content at their convenience, 24-7.
While many online graduate certificate programs do not require any campus visits, some programs hold campus-based workshops and seminars that require students to be on campus for a limited number of days (typically between one and five days). These campus visits, sometimes referred to as intensives or immersion sessions, can enhance the online learning experience by providing students with opportunities to meet face-to-face with instructors and participate in hands-on learning. However, they do require travel and may not be practical for some students. Graduate certificate programs that require more than two or three campus visits per year are classified by GraduateCertificates.com as blended or hybrid programs rather than online programs due to the fact that they may not be a practical option for students who do not live within commuting range of the school offering the program.
Examples of Online Graduate Certificates in Regulatory Affairs
The following programs are meant to provide an overview of the types of graduate certificates programs in regulatory affairs that are currently offered online by accredited colleges and universities.
The University of Southern California (USC) offers an online Graduate Certificate in Regulatory and Clinical Affairs program through its School of Pharmacy and its Department of Regulatory and Quality Science. The 12-credit program consists of one introductory course, two advanced courses in regulation and quality assurance, and one elective. It is designed for students who hold a bachelor’s degree in any field or discipline from an accredited college or university. Students can complete the program’s four-course curriculum in less than one year and have up to five years to finish the program’s requirements. For further details on the program, visit USC’s Department of Regulatory and Quality Science at regulatory.usc.edu.
The University of Maryland’s School of Pharmacy offers an online Graduate Certificate in Regulatory Science. The certificate consists of the first two courses from the School of Pharmacy’s online Master of Science (MS) in Regulatory Affairs: “Drug, Biologic, and Device Regulation,” which is offered in the fall semester, and “Drug and Biologics Discovery,” which is offered in the spring semester. Students are thus able to complete the certificate program in two academic semesters, or roughly nine months. The 12 credits earned in the certificate program can be applied toward the MS in Regulatory Affairs program if and when a student opts to pursue further graduate studies. For more information on the program, visit the University of Maryland’s School of Pharmacy at www.pharmacy.umaryland.edu.
Northeastern University offers four regulatory affairs graduate certificate programs through its College of Professional Studies (CPS): a Graduate Certificate in Medical Device Regulatory Affairs; a Graduate Certificate in Biopharmaceutical Regulatory Affairs; a Graduate Certificate in Biopharmaceutical International Regulatory Affairs; and a Graduate Certificate in Nonclinical Biomedical Products. All four programs are offered 100% online or on Northeastern University’s Boston campus (the Nonclinical Biomedical Products program is also offered on the Silicon Valley campus in San Jose, CA), and have a six- to twelve-month completion time. Students must complete four to five courses (18 credits) in topics that address regulations and compliance depending on the focus of the graduate certificate program. Credits earned in these programs can be applied toward Northeastern University’s online Master of Science (MS) in Regulatory Affairs program. For more information on these programs, visit the CPS website at cps.northeastern.edu.