Spring 2024 Schedule
Pharmaceutical Regulatory Sciences (PRS)
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Temple U BookstoreA strong science background is required to pursue 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 Pharamceutical 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 2023
- Pharmaceutical Biotechnology (8005) - offered Spring 2024
- Physical Pharmacy I (8006) – offered Spring 2024
- Regulatory Sciences (5575) – offered Spring 2024
- Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I - offered Fall 2023
- Solid Dosage Forms: Small Molecules (8004) (previously Pharmaceutical Manufacturing II) - offered Summer 2024
All matriculated PRS students should take at least two required courses before registering for electives. Many required courses are offered just once a year.
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:
Physical Pharmacy (8006) is only offered in the spring semester of even-numbered years. It is being offered in Spring 2024. Please plan accordingly.
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. Generally limited electives are offered in the summer.
- Preformulation: Small Molecules (8003) - offered once a year (Fall 2023) (previously Pharmaceutical Manufacturing I)
- Solid Dosage Forms: Small Molecules (8004) - offered Summer 2023 (previously Pharmaceutical Manufacturing II)
- Pharmaceutical Biotechnology (8005) - offered Spring 2024
- Physical Pharmacy (8006) - offered only in spring of even-numbered years - offered Spring 2024
- Regulatory Sciences: Managing the Guidelines for Quality (5575) - offered Spring 2024
- IND/NDA Submissions (5495) - offered every semester (fall, spring, and summer)
- Facilities, Utilities and Equipment (5468) - Offered Spring 2024
- Chemistry, Manufacturing and Controls (CMC) (5577) - offered Fall 2023
Spring 2024 PRS Schedule
Online courses use Zoom as the teaching platform. Temple provides Zoom for free to all registered Temple students.
Some PRS courses are also offered on-campus at RAQA's Fort Washington location. 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 David Brickett ([click-for-email]) or Mike Doukas ([click-for-email]) to review how Zoom works, so you'll be ready for your first RAQA class meeting.
RPNow is an online proctoring service that enables you to take exams at almost any location. RPNow charges $15.00 per exam, which you must pay with a credit card at the start of each exam. (You must also pay that fee if you take in RPNow exam in a University computer lab.) 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
Students pursuing the MS in Pharmaceutical Regulatory Sciences must take required courses before registering for electives. Most required courses are only offered once a year.
PHARMACEUTICAL SCIENCE COURSES
WEEKEND COURSE
8005. Pharmaceutical Biotechnology (990) crn: 51044 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for written permission to register.
8:30 am - 3:00 pm Saturdays (1/2 hour lunch): Jan 20, Feb 3, 17, Mar 2, 16, Apr 6, 20. Meets 6 times plus final exam. Make-up, if needed, Apr 27.
Proctored exams: Mar 2 and Apr 20 via Zoom
Faculty: T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, 3rd edition, 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.EVENING COURSE at Fort Washington
8006. Physical Pharmacy (101) crn: 53089 Registration Form for On-Campus Courses
Special note: this course is only offered every other spring semester. The next time it will be offered is Spring 2026, so if you need this for your major, please plan accordingly.
This course is offered both at Ft Washington and online.
Prerequisite: A strong science and math background, which includes a science degree (pharmacy, chemistry, biochemistry, biological or chemical engineering), and at least one course in physical chemistry. RAQA students must include resume with registration form.
6:00 pm - 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Apr 9
Faculty: D. Lebo
Required text: Martin’s Physical Pharmacy and Pharmaceutical Sciences, J. Sinko, Lippincott Williams & Wilkins, 6th ed., (ISBN: 9780781850271).
Not open to students who have taken Pharmaceutics 485.8006. Physical Pharmacy (990) crn: 53075 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Special note: this course is only offered every other spring semester. The next time it will be scheduled is Spring 2026, so if this course is required for your degree, please plan accordingly.
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
This course is offered both at Fort Washington and online.
Prerequisite: A strong science and math background, including a science degree (pharmacy, chemistry, biochemistry, biological or chemical engineering), and at least one course in physical chemistry.
RAQA students must include resume with registration form.
6:00 pm - 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 13, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Apr 9 (RPNow)
Faculty: D. Lebo
Required text: Martin’s Physical Pharmacy and Pharmaceutical Sciences, J. Sinko, Lippincott Williams & Wilkins, 6th ed., (ISBN: 9780781850271).
Not open to students who have taken Pharmaceutics 485.5468. Validation of FUE (Facilities, Utilities and Equipment) (990) crn: 42717 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Good Manufacturing Practices (5477) or appropriate industry experience in GMPs.
7:15 pm – 10:15 pm Wednesdays: Jan 17, 24, 31, Feb 7, 14, 21, 28, Mar 6, 13, 20, 27, Apr 3. Meets 12 times plus final exam. Make-ups, if needed, Apr 10 and 17.
Proctored exam: Feb 28 (RPNow).
Faculty: E. Muegge
No required text.5495. IND/NDA Submissions (990) crn: 20675 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays: Jan 16, 23, 30, Feb 6, 20, 27, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam. No class Feb 13. Make-ups, if needed, Apr 16 and 23.
Proctored exam: Mar 5 (RPNow)
Faculty: A. Smith
No required text.
Not open to students who completed RAQA 495.WEEKEND COURSE
5495. IND/NDA Submissions (991) crn: 31567 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
8:30 am - 2:00 pm Saturdays (1/2 hour lunch): Jan 20, Feb 3, 17, Mar 2, 16, Apr 6, 20. Meets 7 times plus final exam. Make-up, if needed, Apr 27.
Proctored exam: Mar 2 (RPNow)
Faculty: P. Smith
No required text.
Not open to students who completed RAQA 495.5575. Regulatory Sciences: Managing the Guidelines for Quality (990) crn: 53069 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam
Prerequisite: strong science background required. Forward resume to RAQA Office for approval.
5:30 pm – 8:30 pm Mondays: Jan 22, 29, Feb 5, 11, `9 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, Apr 15 and 22.
Proctored exam: Mar 4 (RPNow)
Faculty: T. Schultz
No required text.
Not open to students who have completed RAQA 580.SCHEDULE of ELECTIVES- PRS
RAQA Electives (Students may choose one of the following electives offered this spring)
5474. Process Validation (990) crn: 51030 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course will use RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisites: Strong science background, such as a BS (or higher) in Pharmacy, Chemistry, Biology or Engineering and a basic understanding of pharmaceutical manufacturing processes. RAQA students must submit their resume for written permission to register.
6:00 pm – 9:00 pm Thursdays: Jan 18, 25, Feb 1, 8, 15, 22, 29, Mar 7, 14, 21, 28, Apr 4. Meets 12 times plus final exam. Make-ups, if needed, Apr 11 and 18.
Proctored exam: Feb 29 (RPNow)
Faculty: K. Barnthouse
Required texts: 1) Process Validation in Manufacturing of Biopharmaceutics, 3rd edition, Anurag S. Rathore and Gail Softer, editors, CRC Press 2012, AND 2) How to Validate a Pharmaceutical Process, 1st edition, Steven Ostrove, Eisevier, 2016.
Not open to students who completed RAQA 484 or Pharmaceutics 8484.5572. Vaccines: RA and QA Issues (990) crn: 45613 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
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 Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents’ Day), 26, Mar 4, 11, 18, 25, Apr 1, 8. Meets 12 times plus final exam. Make-ups, if needed, 15 and 22.
Proctored exam: Feb 26 (RPNow)
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, 13th 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, 2nd edition, 2013, Springer. Available in the Temple U Charles Library online.
(4) Plotkin’s Vaccines, 7th 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.SCHEDULE of ELECTIVES- PRS
Pharmaceutical Science Elective (Students may take 8002 or 8007):
EVENING COURSE at Fort Washington
8007. Applied Pharmaceutics (101) crn: 51380 Registration Form for On-Campus Courses
This course is offered both at Fort Washington and online.
Prerequisite: Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for written permission to register.
5:30 pm – 8:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 4, 11, 18, 25, Apr 1, 8, 15. Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29.
Proctored exam: Apr 15
Faculty: R. Fassihi
No required text.
Not open to students who have completed Pharmaceutics 410.8007. Applied Pharmaceutics (990) crn: 53076 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
This course is offered both at Fort Washington and online.
Prerequisite: Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for written permission to register.
5:30 pm – 8:30 pm Mondays: Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 4, 11, 18, 25, Apr 1 8, 15. Meets 12 times plus final exam. Make-ups, if needed, Apr 22 and 29.
Proctored exam: Apr 15 (RPNow)
Faculty: R. Fassihi
No required text.
Not open to students who have completed Pharmaceutics 410.
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
Registration Form for On-Campus Courses
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