Pharmaceutical Regulatory Sciences, M.S.

SCHOOL OF PHARMACY

About the Program

The M.S. in Pharmaceutical Regulatory Sciences (MSPRS) blends two disciplines, pharmaceutical and regulatory sciences, providing a unique and critical academic path for professionals in the pharmaceutical, medical device, and biologics industries:

  • Pharmaceutical science courses focus on the core science principles involved in the development and manufacturing of therapeutic products.
  • RAQA courses provide a strong framework of regulations and quality practices, addressing scientific methods needed to ensure safety, efficacy, quality, and consistent performance.

The MSPRS program is designed to prepare a cadre within the pharmaceutical industry of senior regulatory professionals who are familiar with both the pharmaceutical sciences and worldwide regulatory practices as they interact with the FDA and other global regulators in bringing new chemical entities and biologics to market.

Time Limit for Degree Completion: 5 years

Campus Location: Online

Full-Time/Part-Time Status: The degree program can be completed on a full- or part-time basis.

Interdisciplinary Study: The program fosters interdisciplinary study with the pharmaceutical sciences and technology.

Job Prospects: The program prepares graduates for positions in the global marketplace related to the pharmaceutical and regulatory sciences.

Non-Matriculated Student Policy: Non-matriculated students are able to take up to 9 credits before formal application must be made to the program.

Financing Opportunities: Master's-level students are generally not considered for financial support.

Admission Requirements and Deadlines

Application Deadline:

Fall: March 1; December 15 international
Spring: November 1; September 1 international
Summer I: March 1; January 15 international

Applications are processed throughout the year. Late applications may be considered for admission. However, the entire application packet must be received by the Graduate Studies Office before it is reviewed by the Admissions Committee. Applicants are responsible for making sure that all materials have been received.

APPLY to this graduate program, submitting the application to QARA2@temple.edu. For more information, visit https://www.temple.edu/pharmacy_qara/applyingtoMS.html.

Letters of Reference:
Number Required: 2

From Whom: Letters of recommendation should be obtained from supervisors or college/university instructors familiar with the student's academic competence.

Bachelor's Degree in Discipline/Related Discipline: A baccalaureate degree in Pharmacy, Biochemistry, Biology, Chemistry, Chemical Engineering, or Mechanical Engineering is required.

Applicants who did not achieve a 3.0 undergraduate GPA in a science discipline may be admitted after taking three of the four courses listed below and earning an overall 3.33 (B+) GPA in the coursework:

PS 8002Pharmaceutical Analysis3
PS 8005Pharmaceutical Biotechnology3
PS 8006Physical Pharmacy I3
QARA 5575Regulatory Sciences: Managing the Guidelines to Quality3

Statement of Goals: Describe your career goals and objectives in 500 to 1,500 words.

Standardized Test Scores:
Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master’s degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:

  • TOEFL iBT: 85

  • IELTS Academic: 7.0

  • PTE Academic: 58

 Resume: Current resume or CV required.

Transfer Credit: Students may transfer a maximum of 6 credits into the M.S. program. These credits must be similar or identical to courses offered by the Temple University School of Pharmacy and applicable to the M.S. in Pharmaceutical Regulatory Sciences. In addition, the student must request the transfer credits at the time of application to the M.S. program, providing copies of course syllabi. The maximum number of credits a student may transfer is 6.

Program Requirements

General Program Requirements:
Number of Credits Required Beyond the Baccalaureate: 30

Required Courses:

Core Courses
PS 8003Pharmaceutical Manufacturing I: Preformulation/Formulation3
PS 8004Pharmaceutical Manufacturing II3
PS 8005Pharmaceutical Biotechnology3
QARA 5468Validation of Facilities, Utilities and Equipment (FUE)3
QARA 5495Investigational New Drug/New Drug Application Submissions3
QARA 5575Regulatory Sciences: Managing the Guidelines to Quality3
QARA 5576Global CMC Issues and Regulatory Dossier (Or QARA 5577 )3
QARA 8006Physical Pharmacy I3
Pharmaceutical Sciences Elective
Select one from the following:3
Pharmaceutical Analysis
Applied Biopharmaceutics
Regulatory Affairs and Quality Assurance Elective
Select one from the following:3
Process Validation
High Purity Water Systems
Computerized System Validation
Biologics/Biosimilars: A Regulatory Overview
Vaccines: Regulatory Affairs and Quality Assurance Issues
Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics
Regulatory Strategy: Discovery to Approval
Total Credit Hours30

Culminating Event: Successful completion of coursework is required to earn the M.S. in Pharmaceutical Regulatory Sciences.

Contacts

Program Web Address:

https://www.temple.edu/pharmacy_qara/Pharmaceutical_Regulatory_Sciences.html

Department Information:

Pharmaceutical Regulatory Sciences Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Submission Address for Application:

QARA2@temple.edu

Mailing Address for Application Materials:

Temple University

Pharmaceutical Regulatory Sciences Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, M.S.

Program Coordinator

qara@temple.edu

267-468-8560

Graduate Chairperson:

Swati Nagar, Ph.D.

phscgrad@temple.edu

Chairperson:

Wendy Lebing, MALD, M.S.

wlebing@temple.edu

267-468-8560