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

LATE AFTERNOON COURSE at Fort Washington (*description on last page of schedule).

5650. Pharmaceutical Regulatory Leadership (101) crn: 13914 (ON-CAMPUS COURSE)    
Suggested prerequisite:  Drug Development (5459) OR Food and Drug Law (5592).
2:00 pm – 5:30 pm Wednesdays:  May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31. Meets 10 times plus final exam.  No class July 3.  Make-ups, if needed, Aug 7 and 14.
In-class, proctored exam:  June 19.
Faculty:  P. Sax
Suggested texts: The Practice of Management, P. Drucker; The Definitive Drucker, E.H Edersheim, Who Moved My Cheese, S Johnson.

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.

ONLINE COURSES

5401. Fundamentals of Pharmacology & Pharmacokinetics (990) crn: 13329 RPNow proctoring.  $15.00 fee . 
Prerequisite: science background
6:00pm – 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)

5459. Drug Development (991) crn: 6040 (ONLINE) RPNow online proctoring.  $15.00 . 
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)

5472. Pharmaceutical Marketing (990) crn: 13919 (ONLINE) RPNow online proctoring. $15.00 fee directly to
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).

5476. Good Laboratory Practices (990) crn: 13938 (ONLINE) RPNow online proctoring.$15.00 fee  
6:00 pm – 9:00 pm Wednesdays:  May 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31, Aug 14, 21. Meets 12 times plus final exam.  No class July 3 and Aug 7.  Make-ups, if needed, Aug 28 and Sept 4.
Proctored exam: July 10 (RPNow)

5514. Regulatory eSubmissions (990) crn: 13918 (ONLINE) RPNow online proctoring. $15.00 fee  
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)