Program Overview

Introduction to the MS in Pharmaceutical Regulatory Sciences Program

The MS in Pharmaceutical Regulatory Sciences Program is designed to address the immediate need for professionals well-versed in Regulatory Science. The program is offered by Temple University's School of Pharmacy and is tailored to provide students with a strong foundation in regulatory affairs and quality assurance.

Program Overview

The program is designed to bridge the gaps in knowledge that often exist between pharmaceutical science and regulatory affairs. The curriculum offers courses from both pharmaceutical science and regulatory affairs, providing students with a comprehensive understanding of the complex integration of regulations, quality practices, and scientific knowledge required to bring regulated healthcare products to market.

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
  • Statement of career goals and objectives (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 or 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 be completed first, as 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 Molecules (8003) (previously Pharmaceutical Manufacturing I: Preformulation/Formulation)
• Solid Dosage Forms - Small Molecules (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)