Summer 2025 Schedule  Advanced Biotherapeutics: Manufacturing and Regulatory Affairs (ABMRA) (Updated 4/17/25) Offered jointly with the Jefferson Institute of Bioprocessing in Springhouse, PA, part of Jefferson University

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A 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 Bioprocessing 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 Bioprocessing 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 (taking 6 electives credits in RAQA); students wishing to focus on hands-on manufacturing issues of biopharmaceuticals should pursue the Jefferson degree (taking 6 electives credits at JIB).

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 degree

     Bioprocess 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 degree

After 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 2025 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 Jessie Chen (jessie.chen@temple.edu) or David Brickett ([click-for-email]) to review how Zoom works, so you'll be ready for your first RAQA class meeting.

Proctorio is an online proctoring service that enables you to take exams at almost any location.  If a course uses Proctorio, 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 $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, and then $150 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

5459. Drug Development (990) crn: 2539  (ONLINE)   Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 and 20.
Proctored exam:  June 25 (Proctorio)
Faculty:  C. Ciliberto
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459.

WEEKEND COURSE
5459. Drug Development (991) crn: 6040 (ONLINE)  Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
9:00 am - 12:00 pm Sundays: May 18, June 1, 8, 15, 22, 29, July 13, 20 (recording), 27, Aug 3, 10, 17. Meets 12 times plus final exam. No classes on May 25 and July 6. Make-up, if needed, Aug 24.
Proctored exam:  July 13 (Proctorio)
Faculty: M. Rubio
Suggested text: Drugs, From Discovery to Approval, 3rd edition, Rick Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
Not open to students who have completed RAQA 459.

5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 14470 (ONLINE) Proctorio online proctoring  Expectations of Online Students  Registration Form for Online Courses
Prerequisites: Drug Development (5459). Science background required.
6:00 pm - 9:00 pm Wednesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23, 30, Aug 6.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 13 and 20.
Proctored exam: July 9 (Proctorio)
Faculty:  F. Diana
No required text.

RAQA ELECTIVE COURSES: in the ABMRA DEGREE PROGRAM

5514. Regulatory eSubmissions (990) crn: 42720 (ONLINE) Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
Strongly Suggested Prerequisite: Drug Development (5459) or IND/NDA Submissions (5495) OR submit resume demonstrating familiarity with drug development or IND/NDA processes.
6:00 pm - 9:00 pm Tuesdays:  May 20, 27, June 3, 10, 17, 24, July 8, 15, 22, 29, Aug 5, 12. Meets 12 times plus final exam. No class July 1. Make-ups, if needed, Aug 19 and 26.
Proctored exam: June 24 (Proctorio)
Faculty: R. Arbaugh
No required text.

5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (ONLINE) Proctorio online proctoring Expectations of Online Students  Registration Form for Online Courses
Suggested prerequisite: Good Clinical Practices (5536).
7:00 pm - 10:15 pm (eastern) Thursdays: May 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 7, 14, 21.  Meets 11 times plus final exam.  No class July 3. Make-up, if needed, Aug 28.
Proctored exam:  Aug 21 (Proctorio).
Faculty:  J. Robinson
Suggested text: Cobert’s Manual of Drug Safety and Pharmacovigilance, 4^th edition only, Feb 2025, Cobert, Gregory, Thomas, Baldridge: https://www.worldscientific.com/worldscibooks/10.1142/13970#t=aboutBook

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