MS in Pharmaceutical Regulatory Sciences - Schedule of Classes
Fall 2023 Schedule
Pharmaceutical Regulatory Sciences (PRS)
Order texts on-line:
Temple U BookstoreA strong science background is required to pursue the MS in Pharmaceutical Regulatory Sciences. This includes a science undergraduate or graduate degree plus at least 2 years of general chemistry, including organic and analytical chemistry courses.
RAQA students with degrees in pharmacy, chemistry, biochemistry, biology or chemical engineering are 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 Fall 2023
- Physical Pharmacy I (8006) – offered Spring 2024
- Regulatory Sciences (5575) – offered Summer 2023
- Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I - offered Fall 2023
- Solid Dosage Forms: Small Molecules (8004) (previously Pharmaceutical Manufacturing II - offered Spring 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 $35 per exam, then $50 per exam, and 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. The next time it will be offered is Spring 2024.
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 Fall 2023
- Physical Pharmacy (8006) - offered only in spring of even-numbered years - offered Spring 2024
- Regulatory Sciences: Managing the Guidelines for Quality (5575) - offered Summer 2023, probably Spring 2024
- IND/NDA Submissions (5495) - offered every semester (fall, spring, and summer)
- Facilities, Utilities and Equipment (5468) -
- Chemistry, Manufacturing and Controls (CMC) (5577) - offered Fall 2023
FALL 2023 PRS Schedule
Fall 2023 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 (dbrick@temple.edu) or Mike Doukas (mdoukas@temple.edu) 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.
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.
ONLINE
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.
Prerequisite: Strong science background required. RAQA students must submit their resume for written permission to register.
5:30 pm - 8:30 pm Tuesdays: Sept 12, 19, 26, Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. Make-ups, if needed, Dec 5 and 12.
Proctored exam: Oct 24 (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 have completed Pharmaceutics 406.5495. 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 Tuesdays: Sept 12, 19, 26, Oct 3, 17, 24, 31, Nov 7, 14, 21, 28. Meets 12 times plus final exam. No class Oct 10. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: A. Smith
No required text.
Not open to students who completed RAQA 495.JUST ADDED!
5495. IND/NDA Submissions (992) crn: 54616 (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): Sept 16 (Rosh Hashanah), 30, Oct 14, 28, Nov 11, Dec 2, 9. Class meets 7 times plus final exam. Make-up, if needed, Dec 16.
Proctored exam: Oct 28 (RPNow)
Faculty: P. Smith
Not open to students who completed RAQA 495.5577. Global CMCs: Biopharmaceuticals & Other Biologics (990) crn: 28578 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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 Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9 (Columbus Day), 16, 23, 30, Nov 6, 13, 20, 27. Meets 12 times plus final exam. Make-ups, if needed, Dec 4 and 11.
Proctored exam: Oct 16 (RPNow)
Faculty: J. Quinn
Required text: 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
ON-CAMPUS – Pharmaceutical Science Elective
8002. Pharmaceutical Analysis (Fort Washington) (1) crn: 17006 Registration Form for On-Campus Course
This course is offered both online and on-campus at Fort Washington.
Prerequisite: strong science background: 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: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9, 16, 23, 30, Nov 6, 13, 27, Dec 4, 11. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 4 and 11.
Proctored exams: Oct 23 and Dec 11.
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411.Pharmaceutical Science Elective: Students must take 8002 or 8007.
8002. Pharmaceutical Analysis (990) crn: 46377 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both online and on-campus at Fort Washington.
Prerequisite: strong science backgrounds. 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 written permission to register.
5:30 pm - 8:30 pm Mondays: Sept 11, 18, 25 (Yom Kippur), Oct 2, 9, 16, 23, 30, Nov 6, 13, 27, Dec 4, 11. Meets 12 times plus final exam. No class Nov 20. Make-ups, if needed, Dec 18.
Proctored exams: Oct 23 and Dec 11 (via Zoom)
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411.RAQA Electives (Students may choose one of the following)
WEEKEND ON-CAMPUS COURSE at Fort Washington
5516. Cleaning Validation (101) crn: 42747 Registration Form for On-Campus Courses
This course is offered both online and on-campus at Fort Washington
9:00 am - 3:30 pm Sundays (1/2 hour lunch): Sept 10, 17, Oct 8 (Columbus Day weekend), 22, Nov 5, 19, Dec 10. Meets 6 times plus final exam. Make-up, if needed, Dec 17. Mandatory field trip: Nov 19.
Proctored exam: Dec 10
Faculty: A. Walsh
Required text: Cleaning Validation: Science, Risk and Statistics-based Approaches, A. Walsh. Order from: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.htmlWEEKEND ONLINE COURSE
5516. Cleaning Validation (990) crn: 46251 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course is offered both online and on-campus at Fort Washington
9:00 am - 3:30 pm Sundays (1/2 hour lunch): Sept 10, 17, Oct 8 (Columbus Day weekend), 22, Nov 5, 19, Dec 10. Meets 6 times plus final exam. Make-up, if needed, Dec 17. Mandatory field trip: Nov 19.
Proctored exam: Dec 10 (via Zoom)
Faculty: A. Walsh
Required text: Cleaning Validation: Science, Risk and Statistics-based Approaches, A. Walsh. Order from: www.centerforpharmaceuticalcleaninginnovation.org/textbook-page.htmlDAYTIME ONLINE 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 12, 14 - watch recording before Sept 19
Sept 19, 21 - watch recording before Sept 26
Sept 26, 28 - watch recording before Oct 3
Oct 3, 5 - watch recording before Oct 10
Oct 10, 12 – watch recording before Oct 17
Oct 17, 19 - watch recording before Oct 24
Oct 24, 26 - watch recording before Oct 31
Oct 31, Nov 2 - watch recording before Nov 7
Nov 7, 9 - watch recording before Nov 14
Nov 14, 16 - watch recording before Nov 21
Nov 21 and 28 - watch recording before Dec 5, no class Nov 23, Thanksgiving
Dec 5 and 7 (last live class)
Make-ups, if needed, Dec 12 and 14.
Proctored exam: Oct 19 (RPNow)
Faculty: T. Preziosi
No required text.
Not open to students who completed RAQA 498.ONLINE COURSE
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.
Prerequisite: Drug Development (5459) and a science background.
6:00 pm - 9:00 pm Wednesdays: Sept 13, 20, 27, Oct 4, 11, 18, 25, Nov 1, 8, 15, 29, Dec 6. Meets 12 times plus final exam. No class Nov 22. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 25 (RPNow)
Faculty: F. Diana
No required text.STARTS in OCTOBER - ONLINE COURSE
5572. Vaccines: RA and QA Issues (990) crn: 39783 (ONLINE) Expectations of Online Students Registration Form for Online Courses CLOSED. WAIT LIST ONLY.
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).
6:00 pm - 9:30 pm Tuesdays: Oct 3, 10, 17, 24, 31, Nov 7, 14, 21, 28, Dec 6. Meets 10 times plus final exam. Make-ups, if needed, Dec 13 and 20.
Proctored exam: Oct 31 (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.
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 fax a RESIDENCY FORM
Will this be your fourth course in the Pharmaceutics program? If so, you must fax a Non-Matriculated Graduate Student Waiver