Regulatory Affairs and Quality Assurance Graduate Program of Temple University School of Pharmacy

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RA and QA Online Courses – Spring 2018

Spring 2018 registration is officially open. Students may forward registration forms now to hold their spot in a course. Only complete forms will hold your spot. Registration forms will not be processed until January 11th. Tuition bills will be due in mid-February.

Click here for more information on how to register for an online course.

CLASSES ARE LISTED NUMERICALLY IN EAST COAST TIMES (please adjust accordingly for your time zone).

Schedule updated: December 6, 2017

Students are required to purchase headsets with microphones to participate in Adobe Connect online classes. They must also have a webcam on their laptop/computer. 

Due to U.S. visa requirements, full-time international students are expected to take all courses in an on-campus format.

Please review all schedule dates carefully. Students are expected to participate in exams on the stated dates and to reserve listed make-up dates, in case of inclement weather or other unexpected cancellations.

5459.  Drug Development (990) crn:   7447 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed,  Apr 16 or 23.
Proctored exam:  Feb 26 (Software Secure).
Faculty:  A. Traettino  
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 459.

5459.  Drug Development (991)  crn:  28687 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12, 19 (Proctored, final exam).
Meets 12 times plus final exam.
Make-up, if needed, Apr 26 or May 3.
Proctored exam:  Apr 19.
Faculty:  S. Galle
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 459.

WEEKEND COURSE
5459.  Drug Development (992) crn:   28931 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
10:00 am - 1:00 pm Saturdays:  Jan 20, 27, Feb 3, 10, 17, 24, Mar 3, 10, 17, 24, 31, Apr 7.  Meets 12 times plus final exam.   Make-ups, if needed, Apr 14 or 21.
Proctored exam:  Feb 24.
Faculty:  D. Walsh
Required text:  Drugs From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272);  2) New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  AND,
3) The Great Influenza: The Epic Story of the Deadliest Plague in History, Barry, Penguin Group, 2005, (ISBN: 13-9780143036494).
Not open to students who have taken Pharmaceutics 459.

5459.  Drug Development (993) crn:   36993 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.   Make-ups, if needed, Apr 17 or 24.
Proctored exam:  Feb 27.
Faculty:  D. Walsh
Required text:  Drugs From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272);  2) New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  AND,
3) The Great Influenza: The Epic Story of the Deadliest Plague in History, Barry, Penguin Group, 2005, (ISBN: 13-9780143036494).
Not open to students who have taken Pharmaceutics 459.

5471.  Biotechnology:  Bioprocess Basics  (990)  crn: 28688 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  undergraduate introductory biochemistry and chemistry courses. Include resume with registration form.
6:00 pm - 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.
Proctored exam:  Mar 5 (Software Secure)
Faculty:  J. Quinn
No required text.
Not open to students who have taken Pharmaceutics 481.

5477.  Good Manufacturing Practices (990)  crn:   3439 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:30 pm - 9:30 pm  Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11, 18 (proctored final).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 25 or May 2. Proctored exam:  Apr 18 (Software Secure).
Faculty:  M. Noonan
No required text.
Not open to students who have taken Pharmaceutics 487.

5491.  Pre-Approval Inspections (990) crn:  31572 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
Prerequisites:  Drug Development (5459) and GMPs (5477).
6:00 pm – 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28 Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam.    Make-ups, if needed, Apr 18 or 25.
Proctored exam:  Feb 28.
Faculty:  K. Campbell and D. Pagano
No required text.
Not open to students who have taken Pharmaceutics 490.

5494.  Quality Audit (990) crn:   31574 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  a good practices (GxP) course: GLPs (5476) , GMP (5477), Advanced GMPs (5479), or GCPs (5536).
6:00 pm - 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam.   Make-ups, if needed, Apr 18 and 25.
Proctored exam:  Feb 28.
Faculty:  K. Huynh-Ba
Required text:  The ASQ Auditing Handbook, 4th ed, J.P. Russell.  Available from ASQ Quality Audit Division: www.asq.org  (ISBN: 10-0873898478 only).  Do not purchase an ebook copy.  Also available on Amazon.com.
Not open to students who have taken Pharmaceutics 494.

5495.  IND/NDA Submissions (990) crn:   20675 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure 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 Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed,  Apr 16 or 23.
Proctored exam:  Feb 26 (Software Secure).
Faculty:  A. Traettino  
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 495.

5495.  IND/NDA Submissions (991) crn:  31567 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure 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 Thursdays:   Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12, 19.  Meets 12 times plus final exam.    Make-ups, if needed,  Apr 26 or May 3.
Proctored exam:  Mar 15 (Software Secure).
Faculty:  A. Smith
Required text:  Drugs: From Discovery to Approval, Ng, 3rd ed, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have taken Pharmaceutics 495.

5502.  Regulation of Medical Devices:  Submissions (990)  crn:   31565 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24. 
Proctored exam:  Mar 6  (Software Secure).
Faculty:  M.  Arentz
No required text.
Not open to students who have taken Pharmaceutics 500.

5505.  Global Medical Device Regulation (990)  crn:   28689 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm - 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 18 or 25.
Proctored exam:  Mar 7 (Software Secure)
Faculty:  M. Arentz
No required text.
Not open to students who have taken Pharmaceutics 505.

5508.  Good Pharmacovigilance Operations (990)  crn:  28690 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite: Drug Development (5459).
6:00 pm - 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 19 or 26.
Proctored exam:  Mar 8 (Software Secure.)
Faculty:  C. Wittrock
No required text.

5514.  Regulatory eSubmissions (990) crn:   28692 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Suggested prerequisites:  Drug Development (5459) and IND/NDA Submissions (5495).  Students who have not taken both of these courses should submit a resume for permission to register.
6:00 pm - 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, Apr 4, 11, 18.  Meets 12 times plus final exam.  No class Mar 28.  Make-ups, if needed, Apr 25 or May 2.
Proctored exam:  Mar 7 (Software Secure)
Faculty:  K. Davino
No required  text.

5533.  Requirements for Product Labeling and Advertising (990) crn:  31562 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  Food and Drug Law (5592) or permission of instructor.
6:00 pm - 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12, 19 (Proctored final).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 26 or May 4.
Proctored exam:  Apr 19 (Software Secure)
Faculty:  J. Bammert
No required text.
Not open to students who have taken Pharmaceutics 533.

5571.  Post-Marketing Safety Surveillance  (990)  crn:   28696 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
6:00 pm - 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11, 18 (proctored final exam).  Meets 12 times plus final exam.  Make-ups, if needed, Apr 25 or May 2.
Proctored exam:   Apr 18
Faculty:  D. Wallace
Suggested text: Practical Aspects of Signal Detection in Pharmacovigilance, CIOMS Group VIII, 2010, at http://apps.who.int/bookorders/anglai/detart1.jsp?sesslan=1&codlan=1&codcol=84&codcch=30
Suggested text:  Mann's Pharmacovigilance, Andrews and Mann, 2007, Wiley & Sons, Inc., (ISBN:  0470018038).
Not open to students who have taken Pharmaceutics 571 or 538 or 5538.

5572.  Vaccines:  RA and QA Issues (990) crn: 37055 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
6:00 pm - 9:30 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 2 or 9.
In-class, proctored exam:  Mar 19.
Faculty:  D. Casaburi
No required text.
No open to students who have taken Pharmaceutics 572.

5573.  Pharmacoepidemiology (990)  crn: 31616 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9, 16 (proctored, final exam).  Meets 12 times plus final exam.
Make-ups, if needed, Apr 23 or May 7.
Proctored exam:  Apr 16.
Faculty:  N. Cossrow
Required text: Textbook of Pharmacoepidemiology, Strom, 2nd ed, Wiley Publisher, (ISBN:  1118344862).  Temple students may access this book online through the Paley Library link on Banner.
Not open to students who have taken Pharmaceutics 570.

5576.  Global CMC Issues and Regulatory Dossiers (990)  crn:  36991 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24.
Proctored exam:  Mar 6.
Faculty:  F. Diana
No required text.
Not open to students who have taken Pharmaceutics 586.

5591.  Global Regulatory Affairs (990) crn:   20671 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
 This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure 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 Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 19 or 26.
Proctored exam:  Mar 1 (Software Secure)
Faculty:  D. Larkins
No required text.
Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law (990)  crn:   9424 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm  Tuesday:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.    Make-ups, if needed, Apr 17 or 24.
Proctored exam:  tba (Software Secure)          
Faculty:  G. Pilgrim
Required text:  Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN: 1609301757).  Make sure you purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, 2014, (ISBN 9781634591904).
Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law (991) crn: 25838 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
6:00 pm - 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.
Proctored exam:  Mar 5.
Faculty:  B. Berger
Required text: Food and Drug Law: Cases and Materials, 4th ed, Hutt, et al, Foundation Press, (ISBN:  1609301757).  Make sure to 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.
Not open to students who have taken Pharmaceutics 592.

5594.  Regulation of Dietary Supplements, Botanicals, and Nutraceuticals (990)  crn:  36994 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
 This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm – 9:00 pm Tuesdays:  Jan 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17.  Meets 12 times plus final exam.    Make-ups, if needed,  Apr 24 or May 1.
Proctored exam:  Mar 13 (Software Secure).
Faculty:  A. Smith
Required text:  A Global Perspective:  Regulation of Functional Food and Nutraceuticals, Clare M. Master, 5th ed., (ISBN:  0-8138-1177-5).
Not open to students who have taken Pharmaceutics 594.

5601.  Industry Interactions with FDA and Health Authorities (990)  crn: 8726 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm - 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12.  Meets 12 times plus final exam.  Make-ups if needed, Apr 19 or 26.
Proctored exam:  Mar 1 (Software Secure)
Faculty:  A. Traettino
No required text.
Not open to students who have completed Pharmaceutics 601.

5605.  Advanced Topics in Food and Drug Law (990)  crn:  36997 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. For more information on this course, click here.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Prerequisite:  Food and Drug Law (5592) or permission of the instructor (forward resume with registration form).
6:00 pm – 9:00 pm  Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam.    Make-ups, if needed, Apr 18 or 25.
Proctored exam:  tba (Software Secure)           
Faculty:  G. Pilgrim
Required text:  Food and Drug Law: Cases and Materials, 4th edition, Hutt, et al, Foundation Press, (ISBN: 1609301757).  Make sure you purchase the 4th edition (and not earlier editions).
Recommended text:  Statutory Supplement, Hutt, West Academic Publishing, 2014, (ISBN 9781634591904).
Not open to students who have taken Pharmaceutics 605.

5611.  Regulation of Advertising and Promotions (990)  crn:  28698 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm - 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24.
Proctored exam:  Mar 6 (Software Secure)
Faculty:  M. Dronitsky
Required text: FDA Requirements for Prescription Drug Promotion, John Driscoll, RAPS, 2013, (ISBN: 978-0-9829329-7-0).
Not open to students who have taken Pharmaceutics 611.

5612.  Bioethics for Pharmaceutical Professionals (990)  crn:  28699 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Note:  this course may be taken either as a traditional classroom course at Fort Washington or online through Adobe Connect.  Due to visa requirements, full-time international students must take this course in an on-campus format.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
6:00 pm - 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.   Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24.
proctored exam:  Mar 6 (Software Secure)
Faculty:  C. Wittrock
Required text:  Bioethics:  Principles, Issues, and Cases, Vaughn, 3rd edition, 2017, Oxford University Press, ISGN13:  978019025012, ISBN10: 0190250100.
Not open to students who have taken Pharmaceutics 610.

5615.  Project Management for Pharmaceutical Professionals (990)  crn:  31575 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  at least four courses in the RAQA program, including Drug Development (5459) and Food and Drug Law (5592).
6:00 pm - 9:00 pm Tuesdays:  Jan 23,  30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.
Make-ups, if needed, Apr 17 or 24.
Proctored exam:  Feb 27.
Faculty:  J. Sheldon
Suggested text:  Project Management for the Pharmaceutical Industry, Brown and Grundy.
Optional text:  A Guide to the Project Management Body of Knowledge, Project Management Institute.
Not open to students who have taken Pharmaceutics 615.

5618.  Clinical Data Management (990)  crn: 36995 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisites:  Drug Development (5459) and Good Clinical Practices (5536).
6:00 pm - 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9. Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.
Proctored exam:  Mar 5.
Faculty:  D. Adelman
Required text:  Practical Guide to Clinical Data Management, Prokscha, 3rd ed, (ISBN-13:  978-1439848296 or ISBN-10: 1439848297).
Not open to students who have taken Pharmaceutics 618.

5650.  Special Topics:  Current Global Regulatory Issues (990)  crn:  36996 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm - 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 16 or 23.
Proctored exam:  Mar 5.
Faculty:  P. Moriarti
No required text.

Course Description of 5650 - Spring 2018
This course provides a deeper understanding of key, current regulatory trends relating to the development, approval, manufacture and marketing of drugs, biologics, and medical devices.  How are regulators and industry addressing some of these issues?  As much as practical, the subject matter will be related to current business regulatory and legal issues.  At a time when there are significant economic and political issues associated with developing, manufacturing, and promoting drugs, devices, and biologics, we will explore current and recent regulatory actions and trends from a global perspective.

8004.  Pharmaceutical Manufacturing II:  Solid Dosage Forms (990)  crn:  36992 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
This course will use Software Secure online proctoring. Students are responsible for paying a $15.00 fee directly to Software Secure via credit card at the start of the proctored exam. 
Strong science background required, including  2 years of general chemistry, including organic and analytical chemistry. Include resume with registration form.
7:00 pm - 10:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (Presidents' Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, April 16 or 23.
Proctored exam:  Mar 5 (Software Secure)
Faculty:  K. Zimm
No required text.
Not open to students who have taken Pharmaceutics 407.

Students MUST use the Registration Form for Online Courses.

How to Register for an Online Course

Is this your first RAQA registration with Temple? If so, you must include a RESIDENCY FORM

Is this your fourth class with the RA and QA program? If so, you must include a Non-Matriculated Graduate Student Waiver.

Do you want to apply for the MS in QA/RA? Click here to get started.

PRINT AND FAX YOUR FORMS TO: 267.468.8565

You may also email your forms to: qarareg@temple.edu
or, mail your forms to:

Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

Order texts on-line via: Temple University Ambler Bookstore
267-468-8460

Drop/Add Policy

To receive a complete refund for a course, you must notify the RA and QA Office in writing that you are dropping BEFORE the second class takes place (weekend courses) or BEFORE the third class takes place (weeknight courses). Please use the Course Withdrawal Form.

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Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034
Phone: 267.468.8560
E-Mail:
qara@temple.edu