Summer 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 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 - Thursday evenings
- Physical Pharmacy I (8006) – offered Spring 2024, next offered Spring 2026
- Regulatory Sciences (5575) – offered Spring 2024
- Preformulation: Small Molecules (8003) (previously Pharmaceutical Manufacturing I - offered Fall 2024)
- 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. 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 and will be offered again in Spring 2026. 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) (previously Pharmaceutical Manufacturing II)
- Pharmaceutical Biotechnology (8005) - offered Fall 2024 on Thursday evenings
- Physical Pharmacy (8006) - offered only in spring of even-numbered years - offered Spring 2024, next offered Spring 2026
- 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
- Global CMC Issues and Regulatory Dossiers - offered Summer 2024
Summer 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) (ONLINE) Will be offered Fall 2024 on Thursday evenings
5495. IND/NDA Submissions (990) crn: 13915 (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 Thursdays: May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15. Meets 12 times plus final exam. No class July 4 . Make-ups, if needed, Aug 22 and 29.
Proctored exam: June 27 (RPNow)
Faculty: R. Alliegro
Required text: to be announced.
Not open to students who completed RAQA 495.WEEKEND COURSE
5495. IND/NDA Submissions (991) crn: 13939 (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): May 18, June 1, 15, 29, July 13, 27, Aug 10. Meets 7 times plus final exam. Make-up, if needed, Aug 17.
Proctored exam: June 29 (RPNow)
Faculty: P. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition.
Not open to students who completed RAQA 495.5576. Global CMC Issues and Regulatory Dossiers (990) crn: 13920 (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 Mondays: May 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. No class May 27 (Memorial Day). Make-ups, if needed, Aug 19 and 26..
Proctored exam: July 8 (RPNow).
Faculty: F. Diana
No required text.
Not open to students who have completed RAQA 586.
SCHEDULE of ELECTIVES- PRS
Pharmaceutical Science electives not offered this summer. Pharmaceutical Analysis (8002) will be offered in Fall 2024.
RAQA Electives (Students may choose one of the following electives offered this summer)
5478. High Purity Water Systems (990) crn: 12414 (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: college-level chemistry course.
6:00 pm – 9:00 p Tuesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6, 13. Meets 12 times plus final exam. Make-ups, if needed, Aug 20 and 27.
Proctored exam: Aug 13 (RPNow)
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.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