Summer 2024 Schedule
Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA)Offered jointly with the Jefferson Institute of Biotechnology in Springhouse, PA, part of Jefferson University
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Temple U BookstoreA strong science background is required to pursue the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs. This includes a science or engineering undergraduate or graduate degree. To earn this degree, students complete a minimum of 15 credits in Temple's RAQA graduate program plus a minimum of 15 credits at the Jefferson Institute of Biotechnology in Springhouse, PA. Most courses are in this 36-credit MS degree are online. Students are strongly encouraged to enjoy the outstanding state-of-the-art equipment available at the Jefferson Institute of Biotechnology in Springhouse, PA, whenever possible.
Students may earn the ABMRA degree either from Temple University OR from Thomas Jefferson University (but not both). Students wanting to focus on RA issues with biopharmaceuticals should pursue the TU degree; students wishing to focus on hands-on manufacturing issues of biopharmaceuticals should pursue the Jefferson degree.
Required Courses from Temple and Jefferson:
Drug Development (5459) (Temple RAQA)
Biologics/Biosimilars: A Regulatory Overview (5515) (Temple RAQA)
Global CMCs - Biologics (5577) (Temple RAQA)
Vaccines: RA and QA Aspects (5572) (Temple RAQA)
One approved RAQA elective for the ABMRA degreeBioprocess Engineering for Scientists (ENGR 609) (3 credits)
Intro to Biopharmaceutical and Biologics Production (ENGR 621) (3 credits)
Principles of Biopharmaceutical Process Engineering (ENGR 611) (3 credits)
Biopharmaceutical Process Operations (ENGR 604) (3 credits)
One approved JIB elective for the ABMRA degreeAfter completing required courses, students pursue 6 credits from either JIB or RAQA, depending on whether they earn the degree from Jefferson or Temple University.
SUMMER 2024 ABMRA Schedule
All RAQA online courses use Zoom. Temple provides Zoom for free to all registered Temple students.
Some ABMRA 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 and must take JIB courses at the Springhouse, PA, site of that program.
Required hardware
Our online courses are interactive, so you must have a webcam and microphone. Many laptops 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 are expected to take proctored exams on the dates listed in the Schedule. There is a first time fee of $35 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 and then $100 per exam. For more information on proctoring and these fees, click here.
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 not allow software downloads.) Please check this before registering.
REQUIRED COURSES for the MS in Advanced Biotherapeutics: Manufacturing and RA (ABMRA)
Students pursuing the ABMRA MS must take required courses before registering for electives. Most required courses are only offered once a year.
REQUIRED RAQA COURSES
WEEKEND COURSE
5459. Drug Development (990) crn: 2539 (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.
10:00 am – 1:00 pm Saturdays: May 18, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3, 10. Meets 12 times plus final exam. No class May 25 (Memorial Day weekend). Make-ups, if needed, Aug 17 and 24.
Proctored exam: July 13 (RPNow)
Faculty: D. Walsh
Required texts: 1) Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272), and 2) The Great Influenza, John M. Barry, Penguin 2004-5, (ISBN 0-14-303649-1)
Not open to students who have completed RAQA 459.5459. Drug Development (991) crn: 6040 (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 Wednesdays: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: July 10 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng. ISBN: 978-1-118-90726-6.
In addition, students will be required to choose one of the following texts and write a book review:
1) The Poison Squad: One Chemist's Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, Paperback – Illustrated, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair
3) The Great Influenza: The Story of the Deadliest Pandemic in History, Paperback – Oct 2005, John M. Barry
4) The Antidote: Inside the World of New Pharma, Barry Werth.
Not open to students who have completed RAQA 459.RAQA ELECTIVE COURSES
8005. Pharmaceutical Biotechnology (990) to be offered Thursday evenings in Fall 20245479. Advanced Good Manufacturing Practices – Defining ‘c” (990) crn: 7676 (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: successful completion of Good Manufacturing Practices (5477) or permission of RAQA office (send resume for approval).
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: K. Zimm
No required text.
Not open to students who have completed RAQA 479.5501. Development of Sterile Products (990) crn: 13916 (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: Strong science background, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. Include resume with registration form.
6:00 pm - 9:00 pm Thursdays: May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15, 22. Meets 12 times plus final exam. No class July 4. Make-ups, if needed, Aug 29 and Sept 5.
Proctored exam: Aug 22 (RPNow)
Faculty: D. Casaburi
No required text.
Not open to students who have completed RAQA 501.5514. Regulatory eSubmissions (990) crn: 13918 (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).
6:00 pm - 9:00 pm Wednesdays: May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14. Meets 12 times plus final exam. No class July 3. Make-ups, if needed, Aug 21 and 28.
Proctored exam: June 26 (RPNow)
Faculty: R. Arbaugh
No required text.5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (ONLINE) Expectations of Online Students Registration Form for Online Courses
ABMRA students may take 5538 OR 5571 as an RAQA elective but not both.
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 Clinical Practices (5536 or P383) or appropriate experience in industry GCPs (send resume with registration form).
7:00 pm – 10:00 pm Thursdays: May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1, 8, 15, 22. Meets 12 times plus final exam. No class July 4. Make-ups, if needed, Aug 29 and Sept 5.
Proctored exam: Aug 22 (RPNow)
Faculty: J. Robinson
No required text.To register for the Online courses use:
Expectations of Online Students Registration Form for Online Courses
Email your registration form to: QARAREG@temple.edu
OR, PRINT AND FAX YOUR REGISTRATION TO: 267.468.8565
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. Call RAQA at 267.468.8560 for instructions.
Will this be your fourth course in the MS program? If so, you must fax a Non-Matriculated Graduate Student Waiver