Summer 2024
Thursday Classes

Expectations of Online Students

Registration Form for Online Courses

Registration Form for On-Campus Courses

Order texts on-line via
Temple U Bookstore

Note:  Due to visa requirements, international students must attend courses on-campus, which includes taking online courses in the Ft Washington computer lab.

This is a truncated listing of Thursday courses offered in the RAQA Graduate program during the Summer 2024 semester. Refer to the main schedule for complete details about assigned faculty, required texts and previous course numbers.

5000.  KENX Conferences 1.5 credit hours each section
Did you know that you can earn 1.5 credits towards the MS in RAQA by attending specific KENX conferences in either San Diego or Philadelphia?  Each conference meets over 2.5 days.  You attend the sessions marked “Temple Track,” then take a proctored open-book final exam within 6 weeks. For more information on conference topics, see:  kenx.org/conferences   

Topics for Summer 2024 include:

1. Apr 23 – 25, 2024: Validation U, San Diego, CA (in-person only), section 007 crn: 11575
2. June 4 – 6, 2024: Analytical Method Development, Philadelphia, PA (in-person only), section 008, crn: 12423
3. August 6 – 8, 2024: Cleanroom Contamination Control/Environmental Monitoring, San Diego, (in-person only) section 009, crn: 12567

5477. Good Manufacturing Practices (990) crn: 4136 (ONLINE) RPNow online proctoring. $15.00 fee.
6:15 pm - 9:30 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 26 and Sept 5.
Proctored exam:  Aug 22 (RPNow)

5495. IND/NDA Submissions (990) crn: 13915 (ONLINE) RPNow online proctoring. $15.00 fee.
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)

5501. Development of Sterile Products (990) crn: 13916 (ONLINE) RPNow online proctoring. $15.00 fee
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)

5502. Regulation of Medical Devices: Submissions (990) crn: 13332 (ONLINE) RPNow online proctoring. $15.00 fee  
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: July 11 (RPNow)

5513. Active Pharmaceutical Ingredients (990) crn: 13917 (ONLINE) RPNow online proctoring. $15.00 fee
Prerequisite: Drug Development (5459). .
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: July 11 (RPNow)

5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 13333 (ONLINE)  RPNow online proctoring. $15.00 fee  
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)

5650. Patient Focused Regulatory Policy for Medical Products (990) crn: 13922 (ONLINE)RPNow online proctoring.  $15.00 fee . 
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
6:00 pm - 9:00 pm Thursdays: May 23, 30, June 6, 13, 20, 27, Jul 11, 18, 25, Aug 1, 8, 15, 22.  Meets 12 times plus final exam.  No class July 4 (Independence Day).  Make-ups, if needed, Aug 29 and Sept 5.
Proctored exam: Aug 22 (RPNow)
Description:  This course provides an overview of patient-focused regulatory policy that impacts the global regulation of medicines and medical devices. This course will cover the legislative and regulatory history of patient-focused policy at U.S. FDA, such as Patient Preference Information and Patient Focused Drug Development. This course will also survey patient-focused policy efforts around the world in countries such as Canada, Australia, and the European Union, among others. Students will have the opportunity to review literature related to patient engagement, patient preference, and patient experience to understand the subtle methodological and policy-specific differences between these concepts. Topics will include evidence for the value of patient engagement in product development, examples of medical products cleared or approved using patient input, and expectations by regulators for the use of patient-generated data to support regulatory submissions. The value of including the patient voice in regulatory decision-making, the impact of patient-focused policy on regulatory decisions, and current policy issues, challenges, and opportunities will also be discussed.