MS in Pharmaceutical Regulatory Sciences - Schedule of Classes

 

Summer 2025 Schedule
 Pharmaceutical Regulatory Sciences (PRS)

Order texts through online TU Bookstore
 

A strong science background is required for the MS in Pharmaceutical Regulatory Sciences, which means a science undergraduate or graduate degree plus at least 2 years of general chemistry, including organic and analytical chemistry courses. Students with degrees in pharmacy, chemistry, biochemistry, biology or chemical engineering are also welcome to pursue PRS courses.  Please include your resume when registering for PRS courses. Non-matriculated students hoping to pursue the MS in PRS are also required to provide a resume with their registration form.

The MS in Pharmaceutical Regulatory Sciences does not require a thesis.

Students who have not matriculated (been formally accepted) into the MS in Pharmaceutical Regulatory Sciences may start the program ONLY by taking 3 of the following six courses first and earning an overall 3.33 GPA: 

  • Pharmaceutical Analysis (8002) -  offered Fall 
  • Pharmaceutical Biotechnology (8005) 
  • Physical Pharmacy I (8006) – next offered Spring 2026
  • Regulatory Sciences (5575) 
  • Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I 
  • Solid Dosage Forms: Small Molecules (8004) (previously Pharmaceutical Manufacturing II) 

All matriculated PRS students should take at least two required courses before registering for electives. Required courses are usually offered in the fall and spring semesters, so plan accordingly.

You are expected to take proctored exams on the dates listed in the Schedule. There is a first time fee of $25 charged to any student who cannot take the exam on the designated date and requests a makeup test; in subsequent semesters, the fee increases to $50 per exam, then $100, and then $150 per exam. For more information on proctoring and these fees, click here.

Special Notes

Required courses in the MS in Pharmaceutical Regulatory Sciences are listed below. Most are only offered in the fall and spring semesters. Limited electives are offered in the summer.

SUMMER 2025 PRS Schedule 

Online courses use Zoom as the teaching platform. Temple provides Zoom for free to all registered Temple students.

International students with F-1 visas are required to take on-campus courses or to pursue online courses in the Fort Washington Computer Lab.

Required hardware
Our online courses are interactive, so you must have a webcam and microphone. Many laptops already have built-in webcams and speakers. If you use a device that does not, you will be required to purchase them. 

If you're a new student, watch our online course tutorial. A password is given at the end which must be included on your registration form. 

After watching the tutorial, schedule a short Zoom meeting with Jessie Chen (jessie.chen@temple.edu) or David Brickett () to review how Zoom works, so you'll be ready for your first RAQA class meeting.

Proctorio is an online proctoring service that enables you to take exams at almost any location.  

You must have a laptop or computer for Proctorio exams. (Chrome notebooks, iPad, cell phones and other devices will not work). You must also have administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that will now allow software downloads.)  Please check this before registering.

SCHEDULE of REQUIRED COURSES for the MS in PHARMACEUTICAL REGULATORY SCIENCES (PRS)

WEEKEND COURSE
5495. IND/NDA Submissions (990) crn: 13915 (ONLINE)
Proctorio online proctoring  Expectations of Online Students  Registration Form for Online Courses
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).

8:30 am – 2:00 pm Saturdays: May 17, 31, June 14, 28, July 12, 26, Aug 9. Meets 7 times plus final exam. Make-up, if needed, Aug 16.
Proctored exam:  June 28 (Proctorio)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition. 
Not open to students who have completed RAQA 495.

SCHEDULE of ELECTIVES - PRS

PHARMACEUTICAL SCIENCE ELECTIVE (None offered)

RAQA Electives (Students may choose one of the following electives)

 5478. High Purity Water Systems (990) crn: 12414  (ONLINE) Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
Prerequisite: college-level chemistry course.

6:00 pm – 9:00 pm Tuesdays:  May 20, 27, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam.  Make-ups, if needed, Aug 19 and 26.
Proctored exam:  Aug 12 (Proctorio)
Faculty: W. Collentro
Reference text (available on Charles Library website for registered students): Pharmaceutical Water - System Design, Operation, and Validation, Collentro, 2nd edition, Informa Healthcare, 2011.
Not only to students who have taken RAQA 488.

5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 14470 (ONLINE) Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
Prerequisites: Drug Development (5459). Science background required.

6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 and 20.
Proctored exam: July 9 (Proctorio)
Faculty:  F. Diana
No required text.

Email your registration form to: QARAREG@temple.edu

OR, PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565

Registration Form for Online Courses

Expectations of Online Students

OR, MAIL YOUR REGISTRATION TO:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Is this your first registration in the non-thesis MS program? If so, you must forward a Residency Form to the RAQA Office.  Call for instructions.

Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver