Fall 2024 Schedule
Pharmaceutical Regulatory Sciences (PRS)Order texts on-line:
A 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 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 2024
- Pharmaceutical Biotechnology (8005) - offered Fall 2024
- Physical Pharmacy I (8006) – next offered Spring 2026
- Regulatory Sciences (5575) – to be offered Spring 2025
- Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I - offered Fall 2024)
- Solid Dosage Forms: Small Molecules (8004) (previously Pharmaceutical Manufacturing II) - to be offered Spring 2024
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.
Fall 2024 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 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
8003. Preformulation - Small Molecules (990) crn: 54371 (ONLINE) Expectations of Online Students Registration Form for Online Courses
(Formerly Pharmaceutical Manufacturing I: Preformulation/Formulation)
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.
5:30 pm - 8:30 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26. Meets 12 times plus final exam. Make-ups, if needed, Dec 3 and 10.
Proctored exam: Oct 22 (RPNow)
Faculty: T. Schultz
Required text: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, Taylor & Aulton, 4th edition, 2013, Churchill Livingstone, (ISBN: 9780702042904 or 9780702053931).
Not open to students who completed Pharmaceutics 406.8005. Pharmaceutical Biotechnology (990) crn: 54372 (ONLINE) Expectations of Online Students Registration Form for Online Courses
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17 (proctored midterm), 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exams: Oct 17 and Dec 12 (proctored through Zoom)
Faculty: T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, any of the 3rd through 6th editions should be ordered, Informa Healthcare 2007 (ISBN 10: 1420044370), ISBN 13 978 1420044379). Paperback recommended.
Suggested text: 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.RAQA REQUIRED COURSES for the MS in PRS degree:
5495. IND/NDA Submissions (990) crn: 46250 (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.
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12. Meets 12 times plus final exam. No class on Sept 26 and Nov 28 (Thanksgiving). Make-up date, if needed, Dec 19.
Proctored exam: Oct 24 (RPNow)
Faculty: A. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition.
Not open to students who have completed RAQA 495.5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 28578 (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.
6:00 pm - 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26. Meets 12 times plus final exam. Make-ups, if needed, Dec 3 and 10.
Proctored exam: Oct 15 (RPNow)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, John Geigert, 3rd edition, 2019, Science & Media, NY, ISBN-13: 978-3030137533).SCHEDULE of ELECTIVES - PRS
PHARMACEUTICAL SCIENCE ELECTIVE
8002. Pharmaceutical Analysis (990) crn: 46377 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Prerequisite: strong science background.This consists of a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for permission to register.
5:30 pm - 8:30 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans’ Day), 18, Dec 2, 9. Meets 12 times plus final exam. No class Nov 25. Make-up, if needed, Dec 16.
Proctored exams: Oct 21 and Dec 9 (via Zoom)
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411RAQA Electives (Students may choose one of the following electives offered this fall)
5474. Process Validation (990) crn: 54364 (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: Students should have a basic understanding of pharmaceutical manufacturing processes.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 17 (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.DAYTIME ONLINE PRS ELECTIVE RAQA COURSE with recordings
5498. Computerized Systems Validation (990) crn: 54367 (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.
Noon - 1:00 pm Tuesdays and Thursdays (Eastern time), plus one hour recording each week, which students must watch before the next scheduled class:
Sept 10, 12 - watch recording before Sept 17
Sept 17, 19 - watch recording before Sept 24
Sept 24, 26 - watch recording before Oct 1
Oct 1, 3 (Rosh Hashanah) - watch recording before Oct 8
Oct 8, 10 – watch recording before Oct 15
Oct 15, 17 - watch recording before Oct 22
Oct 22, 24 - watch recording before Oct 29
Oct 29, 31 - watch recording before Nov 5
Nov 5, 7 - watch recording before Nov 12
Nov 12, 14 - watch recording before Nov 19
Nov 19 and 21 - watch recording before Dec 3
No class Nov 26 and 28 (Thanksgiving holiday)
Dec 3 and 5 (last live class)
Make-ups, if needed, Dec 10 and 12.
Proctored exam: Oct 17 (RPNow)
Faculty: T. Preziosi
No required text.
Not open to students who completed RAQA 498.5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 28574 (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.
Prerequisites: Drug Development (5459) or IND/NDA (5495).
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2, 9, 16, 23, 30 (recording), Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: F. Diana
No required text.5572. Vaccines: RA and QA Issues (990) crn: 39783 (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: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (recording), 18, 25. Meets 12 times plus final exam. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Oct 14 (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,3rd edition, 2019, 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.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