The FDA defines Regulatory Science (RS) as the "science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-related products."
Both regulated industry and regulatory agencies need professionals who understand the complex integration of regulations, quality practices, and scientific knowledge required to bring regulated healthcare products to market.
The new Master of Science in Pharmaceutical Regulatory Sciences (PRS) addresses the immediate need for professionals well versed in Regulatory Science. The curriculum offers courses from pharmaceutical science and RAQA (Regulatory Affairs and Quality Assurance), bridging the gaps in knowledge that often exists between these areas.
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 assure safety, efficacy, quality, and consistent performance.
The curriculum draws upon the School’s world-renowned MS program in RAQA. Courses are taught by pharmaceutical scientists actively engaged in research as well as industry experts currently working in R&D, drug development, RA, manufacturing, and validation.
Individuals pursuing this graduate program must have strong science backgrounds which include an undergraduate or graduate degree in the hard sciences.
Courses are offered online on weeknights during three semesters a year. The program may be pursued on a part-time basis, enabling working professionals to earn a degree while being employed full-time. Through careful planning, the degree may be finished within two to three years.
PROGRAM ADVANTAGES
- Start courses any time of year (fall, spring, or summer);
- Enjoy weeknight courses that are offered in an interactive, online format;
- Take up to three courses before applying to the MS degree;
- Network with professionals across the U.S. and world.
- No thesis required. 30 credits (10 courses) to earn the degree.
ADMISSIONS - Academic Requirements for Applicants
- An undergraduate or graduate science degree in pharmacy, chemistry, biochemistry, biology, chemical engineering, or mechanical engineering;
- An overall undergraduate grade point average (U-GPA) of 3.0 is required.
- Those who have not achieved a 3.0 U-GPA in a science discipline may gain admittance by taking three of the four courses listed below and earning an overall 3.33 (B+) GPA.
- Pharmaceutical Analysis (8002)
- Pharmaceutical Biotechnology (8005)
- Physical Pharmacy I (8006)
- Regulatory Sciences: Managing the Guidelines for Quality (5575)
APPLICATION PROCESS - Submit the following items
- Graduate application form and fee;
- Official undergraduate and graduate transcripts (including Temple University) indicating a GPA of 3.0 or higher on a 4.0 scale;
- Two letters of recommendation from supervisors or college/university instructors familiar with the student's academic competence;
- State of career goals and obejectives (500-1,500 words) stated and signed;
- Signed and dated CV or resume;
- Applicants whose native language is not English must submit a minimum TOEFL score of 230 (CBT), 585 on the paper-based version, or 85 (IBT). An IELTS of 7.0 of higher is required in the Academic Test scores section in lieu of a TOEFL.
- Application deadlines: Fall Admission (July 20), Spring Admission (November 1), Summer Admission (March 20).
DEGREE REQUIREMENTS FOR MS IN PHARMACEUTICAL REGULATORY SCIENCES
- 30 credits must be completed, including 24 required and 6 elective credits from the lists below.Required courses should complete required courses first, since they provide a foundation of knowledge for subsequent coursework.
- Students may receive a maximum of six semester hours of transfer credit from other schools, provided the courses are found to be the equivalent of courses offered in Temple's MS in Pharmaceutical Regulatory Sciences, a grade of B or higher was earned, and courses are no more than five years old.
- Students will be given five years to complete the degree. No research or thesis is required.
Required Courses for the MS in Pharmaceutical Regulatory Sciences:
- Preformulation: Small Molecues (8003) (previously Pharmaceutical Manufacturing I: Preformulation/Formulation)
- Solid Dosage Forms - Small Molecues (8004) (previously Pharmaceutical Manufacturing I: Solid Dosage Forms).
- Pharmaceutical Biotechnology (8005)
- Physical Pharmacy (8006) - offered only in spring of even-numbered years
- Regulatory Sciences: Managing the Guidelines for Quality (5575)
- IND/NDA Submissions (5495)
- Facilities, Utilities and Equipment (5468)
- Chemistry, Manufacturing and Controls (CMC) (5576 or 5577)
Electives: One elective in Pharmaceutical Science and One elective in RAQA from the following:
Pharmaceutical Science electives (students must take one):
- Pharmaceutical Analysis (8002)
- Applied Biopharmaceutics (8007)
RAQA electives (students must take one)
- Process Validation (5474)
- High Purity Water Systems (5478)
- Biologics/Biosimilars (5515)
- Cleaning Validation (5516)
- Vaccines: RA and QA Issues (5572)
- Global CMCs: Biopharmaceuticals and Other Biologics (5577)
- Regulatory Strategy (5606)
For the most current schedule of classes, click here.
For further information about the programs, please contact:
RAQA Graduate Program - for flyers about the program (NEND+ryczrg+hqr)
Wendy Lebing, MALD, MS, Assistant Dean
RAQA Graduate Program
267-468-8560
qara@temple.edu
Peter Doukas, PhD, Academic Coordinator RAQA
215-707-7883
peter.doukas@temple.edu
Brenda Haslego, Administrative Coordinator for Applications
267-468-8559
QARA2@temple.edu
Swati Nagar, PhD, Director of Graduate Studies
215.707.4948
phscgrad@temple.edu