Spring 2025 Schedule  Pharmaceutical Regulatory Sciences (PRS) PDF Copy of PRS Schedule

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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) - offered Spring 2025 
• Physical Pharmacy I (8006) – next offered Spring 2026
• Regulatory Sciences (5575) – offered Spring 2025
• Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I -  offered Fall 2024)
• Solid Dosage Forms: Small Molecules (8004) (previously Pharmaceutical Manufacturing II) - offered Spring 2025

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 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, so we urge students to complete them as soon as possible. Limited electives are offered in the summer.

SPRING 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 ([click-for-email]) 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. If a course uses RPNow, all students in the class must use that service. 

You must have a laptop or computer for RPNow 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)

5575. Regulatory Sciences:  Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: strong science background required. Include resume with registration for approval.
5:30 pm – 8:30 pm Tuesdays:  Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam.  Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Mar 4 (Proctorio)
Faculty:  T. Schultz
No required text.
Not open to students who have completed RAQA 580.

8004. Solid Dosage Forms – Small Molecules (990) crn: 55324 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:00 pm Wednesdays: Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 (Passover) and 23.
Proctored exam:  Mar 5 (Proctorio)
Faculty:  K. Zimm
No required text.
Not open to students who have completed PS 407.

8005.  Pharmaceutical Biotechnology (990) crn: 51044 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
6:00 pm – 9:00 pm Thursdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17. Meets 12 times plus final exam. Make-up, if needed, Apr 24 and May 1.
Proctored exams: Mar 6 and Apr 17 (proctored through Zoom)
Faculty:  T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, Eds, any of the 3rd through 6^th editions should be ordered, Informa Healthcare 2007 (ISBN 10: 1420044370), ISBN 13 978 1420044379). Paperback recommended. Suggested: Biopharmaceutical: Biochemistry and Biotechnology, Walsh, G., 2nd edition, (ISBN 0 470 84327 6), available online. Students should have access to textbooks in biochemistry and/or molecular biology.
Not open to students who have completed Pharmaceutics 475.

5495. IND/NDA Submissions (990) crn: 20675 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Mondays:  Jan 27, Feb 3, 10, 17 (Presidents’ Day), 24, Mar 3, 10, 17, 24, 31, Apr 7, 14 (Passover).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 21 and 28.
Proctored exam: Mar 10 (Proctorio)
Faculty: A. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8^th revised edition. 
Not open to students who have completed RAQA 495.

5495. IND/NDA Submissions (991) crn: 31567 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am – 2:00 pm Saturdays:  Jan 18, Feb 1, 15, Mar 1, 15, 29, Apr 12. Meets 7 times plus final exam.  Make-up, if needed, Apr 26.
Proctored exam: Mar 1 (Proctorio)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8^th 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 offered this spring)

5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring.
This course has limited seats. If you wish to enroll, send in your registration form right away.
Prerequisite: Drug Development (5459). Students are also expected to have a college-level background in general biology and chemistry and some knowledge of general microbiology and/or immunology.
6:00 pm - 9:00 pm Thursdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13 (recording), 20, 27, Apr 3, 10. Meets 12 times plus final exam. Make-ups, if needed, Apr 17 (Passover) and 24.
Proctored exam: Feb 27 (Proctorio)
Faculty:  K. Surowitz
Required texts: Do not purchase texts until AFTER hearing discussion in the first class.
(1) Autism’s False Prophets, Paul Offit, 2008, Columbia University Press. Available in the Temple U Charles Library online.
(2) Epidemiology and Prevention of Vaccine Preventable Diseases, 13^th edition, U.S. Centers for Disease Control (CDC). Students may download individual chapters for free or purchase the paperback from the CDC.
(3) The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and other Biologics, John Geigert, 3rd edition, 2019, Springer. Available in the Temple U Charles Library online.
(4) Plotkin’s Vaccines, 7^th edition, 2018, Plotkin, Orenstein, Offit, Edwards, editors, Elsevior. Available in the Temple U Charles Library online.
Not open to students who have completed RAQA 572.

5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 55328 (ONLINE)  Expectations of Online Students  Registration Form for Online Courses
This course uses Proctorio online proctoring. 
6:00 pm - 9:00 pm Tuesdays: Jan 21, 28, Feb 4, 11, 18, 25, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 (Passover) and 22.
Proctored exam:  Feb 25 (Proctorio)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, J. Geigert, 2024 https://link.springer.com/book/10.1007/978-3-031-31909-9

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