About the MS in Regulatory Affairs and Quality Assurance (RAQA)

The first university to develop a graduate program in Quality Assurance and Regulatory Affairs, Temple School of Pharmacy (TUSP) continues to set the gold standard in this dynamic professional discipline. Since 1968, TUSP has remained in the forefront of industry education, offering more courses in Regulatory Affairs and Quality Assurance than any other similar graduate program.  Each year we continue to add and refine the RAQA curriculum to incorporate the latest trends in regulatory sciences.

RAQA courses expose students to real-world developments in the pharmaceutical industry, from current quality practices to the latest trends in domestic and global regulation.  Throughout their course of study, RAQA students gain a greater appreciation for a broad variety of topics, such as benefit-risk assessment, regulatory intelligence, data mining and statistical relevance, and the complexities of blending pharmaceutical and regulatory science on a global scale.

The majority of students are from the industry, representing the world's foremost pharmaceutical, biopharamceutical and medical device companies.  Their experience and knowledge vary considerably: some are just starting their careers, while others have been involved in industry for thirty years or more. 

With students and faculty drawn from over 300 companies, the networking opportunities are tremendous.  Each classroom experience coalesces the experiences of individuals from multiple aspects of the industry, including quality assurance and control, regulatory science, R&D, manufacturing and validation, clinical research and trials, medical affairs and pharmacovigilance, biotechnology and generic drugs, medical devices and combination products, and marketing and sales. 

Students from the cosmetic, chemical, healthcare and food industries also participate to gain a deeper understanding of quality practices and regulatory compliance.

The pioneer in this educational discipline, TUSP offers highly flexible and convenient scheduling options.  Students may start or end the program in any semester (Fall, Spring or Summer) and also can attend weeknight or weekend courses. Over 50 courses are also offered in an online format.

In addition to the M.S. in RAQA, students may pursue various certificate programs in Regulatory Affairs and Quality Assurance, almost all of which can also be pursued online.  Certificates provide an excellent way for students to earn well-recognized credentials in a specific industry specialty.

Students can:

  • Pursue individual courses to enhance their knowledge of a specific area
  • Earn specific certificates to gain credentials in a specialty
  • Pursue the M.S., either concentrating their electives in a given specialty or selecting courses from multiple industry disciplines (quality, regulatory, clinical, pharmacovigilance, medical devices, etc.)
  • Apply credits earned in a certificate towards the M.S.
  • Pursue additional advanced certificates after receiving the M.S.
  • Start and finish the program any semester:  fall, spring or summer.

RAQA MS Program Requirements

Program Requirements

Students are required to take a minimum of 12 courses (36 credits) to receive the MS in RAQA  Four courses are required:

  • Drug Development (5459)
  • Food and Drug Law (5592)
  • Quality Audit (5494) or IND/NDA Submissions (5494)
  • One Good Practices course from the following:
    • Good Laboratory Practices (5476)  or Good Manufacturing Practices (5477) or  Advanced GMPs – Defining “c” (5479)  or  Good Clinical Practices(5536)

Note: Students may take more than one GxP course while pursuing the MS, but at least one is required.

The remaining 8 courses are RAQA electives of the student’s choosing.  Click here for the complete list of current electives

Bringing Transfer Credits into the RAQA MS Dgree

Temple University permits students to transfer a maximum of 6 credits (or two courses) into the MS in RAQA degree, only under the following circumstances:

1. Requests for transfer credits must be made when the student is applying for admission to an RAQA MS degree program. Transfer credits will not be awarded after a student has been officially admitted  or is completing one of the degrees.

2. All courses being considered for transfer credits must have been taken within the last five years from a fully accredited U.S. college or university. Grades in all transfer courses must be "B" quality (3.0 on a 4.0 scale) or greater.

3. The courses being considered for transfer credits must be identical or very similar to courses currently offered in Temple's MS in RAQA graduate program.  It is the student's responsibility to provide sufficient documentation to demonstrate the similarity, including a course description from the school (in an official school catalogue), a copy of course syllabi (clearly depicting topics covered), and copies of tests or other assignments which demonstrate that the work is equivalent to Temple's Master of Science in RAQA. Without this documentation, the request for transfer credits will be denied.
4. Transfer credits cannot be earned from industry workshops or conferences.  There are no exceptions to this rule.

5. Students are permitted to take no more than three courses (or 9 credits) in the RAQA program before formally applying for admission.  Any Temple RAQA courses completed before matriculation are considered "transfer credits" since the student is not officially admitted to the degree program. 

6. Since the MS in RAQA is a science-based program focusing on regulatory and quality  practices within the pharmaceutical, medical device, biotechnology and related industries, transfer credits for business courses are not accepted.

7. The Graduate Studies Committee will review the request for transfer credits, based on the materials provided by the student. If the transfer credits are approved, the Committee will write a formal letter to the student.  The decision of the Committee is final.

 Waiving Requirements in the MS Program

A maximum of two required courses may be waived in the MS in RAQA degree program only if the student has completed identical courses in RAQA at another accredited U.S. institution of higher learning.  Students must have earned a minimum grade of “B” (3.0 in a 4.0 scale) and provide a syllabus and other pertinent course materials, demonstrating that the course is identical to a requirement offered in Temple's MS in RAQA degree.  When required courses are officialy waived, the student may select elective courses in their place.

The request to waive a required course (Drug Development, Food and Drug Law, GxPs, IND/NDA Submissions, or Quality Audit) must be made when the student submits the application for the MS in RAQA. Retroactive requests will not be reviewed or granted.  Formal permission to waive a required course must be given by the RAQA Academic Coordinator.

Credit will only be given for academic courses taken within the past five years. The Graduate Studies Committee sends written notification indicating whether the request to waive a prerequisite was granted or denied. 

Students who wish to take Advanced GMPs in lieu of GMPs must demonstrate that they have a minimum of 5 years of active experience in GMPs.  An oral exam may be administered to demonstrate that the student is familiar with basic GMPs.

Online Learning in RAQA

RAQA Courses and Curriculum

Certificate Programs - RAQA

MS, Pharmaceutical Regulatory Sciences (PRS) - no thesis required, strong science background required

MS, Global Clinical & Pharmacovigilance Regulations (GCPR) - no thesis required, MD or PharmD required

MS, Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) - in partnership with Thoms Jefferson University's Kanbar College of Design, Engineering & Commerce at the Jefferson Institute for Bioprocessing (JIB) - no thesis required, strong science background required