KENX CONFERENCE COURSES OPEN TO STUDENTS
(Remember, you can take a KENX course On-Demand, around your schedule….)
5000. KENX Conference Topics (1.5 credits each) (007) crn: 11575 Expectations of Online Students. Use the Registration Form for Online Courses for this course.
Refer to the RAQA website for different conference topics and meeting dates, including Cleaning Validation, Environmental Monitoring, Disinfection OR Laboratory, Analytical and Stability Issues AND more!
Conferences may be attended in person, or lectures may be watched on-Demand over a 6-week period.

5495.  IND/NDA Submissions (990) crn: 10664 (ONLINE)   Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Wednesdays:  May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.
Proctored exam:  June 30 (RPNow).
Faculty:  A. Smith
Required text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) OR New Drug Development: A Regulatory Overview, Mathieu, 8th edition, (ISBN: 1-882615-85-9).
Not open to students who have completed RAQA 495.

5505.  Global Medical Device Regulation (990) crn: 11569 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays:  May 19, 26, June 2, 9, 16, 23, 30, July 14, 21, 28, Aug 4, 11. No class July 7. Meets 12 times plus final exam. Make-ups, if needed, Aug 18 and 25.   
Proctored exam:  June 30 (RPNow).
Faculty:  M. Arentz
No required text.
Not open to students who have completed RAQA 505.

5514.  Regulatory eSubmissions (990) crn: 9535 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459) and IND/NDA Submissions (5495) are suggested.  Students who have not taken these courses should submit a resume which indicates industry experience.
6:00 pm – 9:00 pm Wednesdays: May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.
Proctored exam:  June 30 (RPNow)
Faculty:  R. Arbaugh
No required text.

5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 10666 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459). Science background required.  Include resume with registration.
6:00 pm – 9:00 pm Wednesdays:  May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.
Proctored exam:  June 30 (RPNow).
Faculty:  F. Diana
No required text.

5536.  Good Clinical Practices (990) crn: 3423 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays: May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.
Proctored exam:  June 30 (RPNow).
Faculty:  D. Weiss
No required text.
Not open to students who have completed RAQA 536.

5538.  Clinical Drug Safety and Pharmacovigilance (990) crn: 10680 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
Prerequisite:  Good Clinical Practices (5536) or appropriate industry experience in industry GCPS (forward resume with registration form).
7:00 pm – 10:00 pm Wednesdays:  May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam. Make-ups, if needed, Aug 11 and 18.  
Proctored exam:  June 30 (RPNow)
Faculty:  J. Robinson
Tentative:  No required text.
Not open to students who have completed RAQA 538.

5545.  Post Approval Changes (PAC) (990) crn: 11571 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays:  May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4.  Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.
Proctored exam:  June 30 (RPNow)
Faculty:  K. Zimm
No required text.

5592.  Food and Drug Law (990) crn: 1734 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course.
This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Wednesdays: May 19, 26, June 2, 9, 16, 23, 30, July 7, 14, 21, 28, Aug 4. Meets 12 times plus final exam.  Make-ups, if needed, Aug 11 and 18.  
Proctored exam:  June 23 (RPNow).          
Faculty:  G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, West Academic Publishing, (ISBN:  1609301757).  Only purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, (ISBN: 9781634591904). Note: a 2012 edition or later of this text is acceptable. West Academic Publishing gives a 15% discount and free ground shipping to students ordering these texts. You must create an account, use promo code HESTUDENT, and place our order directly through www.westacademic.com .
Not open to students who have completed RAQA 592.