Fall 2024 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program
On-Campus Courses Only
Please check class dates carefully. Students who cannot make scheduled exams will be charged a $25.00 fee for an initial makeup exam. The fee increases to $50.00 for the second missed exam and then $100.00 for the third and subsequent exams. For more on this policy, click here. To comply with U.S. visa requirements, full-time international students must register for and attend on-campus courses. This includes taking online courses in the Ft Washington computer lab.
AFTERNOON ON-CAMPUS COURSE at Fort Washington
5459. Drug Development (101) crn: 49409 Registration Form for On-Campus Courses at Fort
2:00 pm – 5:30 pm Wednesdays: Sept 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20. Meets 10 times plus final exam. Makeup, if needed, Dec 4 and 11.
In-class, proctored exam: Oct 16.
Faculty: P. Sax
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISB-101: 1118907272), and 2) The Drug Hunters: the Improbable Quest to Discover New Medicines, Kirsch, 2017.
Not open to students who completed RAQA 459.
AFTERNOON COURSE at Fort Washington
5650. Pharmaceutical Regulatory Leadership (101) crn: 56676 (ON-CAMPUS COURSE) Registration Form for On-Campus Courses at Fort Washington
Suggested prerequisite: Drug Development (5459) OR Food and Drug Law (5592).
2:00 pm – 5:30 pm Tuesdays: Sept 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19. Make-ups, if needed, Nov 26 and Dec 3.
In-class, proctored exam: Oct 15.Faculty: P. Sax
Suggested texts: The Practice of Management, P. Drucker; The Definitive Drucker, E.H Edersheim, Who Moved My Cheese, S Johnson.
Course description: Leadership in the pharmaceutical industry requires more than regulatory knowledge: it requires key skills to get the job done with various constituents, including coworkers, employees, and management. This course provides insights, rules, tools and requirements needed to lead in the highly regulated pharmaceutical industry. Students will study organizational principles and practices within the framework of the Code of Federal Regulations (specifically 21 CFR 210, 211, 312, 600 and 820). While these regulations provide what is required, they do not describe how to accomplish it. That task is the job of leadership. Using recommended texts, case studies, class lectures, discussions, and individual research, students will learn how to lead and manage in a regulated industry. Participants will gain the insights to support career goals with new understandings of the work and responsibilities that go along with the titles.
Registration Form for On-Campus Courses at Fort Washington
Is this your first RAQA registration with Temple? If so, you must include a RESIDENCY FORM
Is this your fourth class with the RA and QA program? If so, you must include a Non-Matriculated Graduate Student Waiver.
Do you want to apply for the MS in RA and QA? Click here to get started.
PRINT AND FAX YOUR FORMS TO: 267.468.8565
You may also email your forms to: QARAREG@temple.edu
or, mail your forms to:
Temple University
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034
Phone: 267.468.8560
To receive a complete refund for a course, you must notify the RA and QA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.