Summer 2013 Schedule of Classes (Updated June 3, 2013)

Drop/Add Policy

It's not too late to start a summer course! The following courses start the week of May 20th. In addition, many other courses have just met once, and the QA/RA Office may have a recording of the first class. Please call 267.468.8560 or email qara@temple.edu if you wish to register:

Courses that Start the Week of June 3

5599.  Clinical Aspects of Pharmaceutics Medicine I (111) crn: 4234
To learn more about this course: http://qara-apache.temple.edu/Fletcher/AF5599CAPM1C/index.html or http://qara-apache.temple.edu/Fletcher/AF5599CAPM1B/index.html
8:30 am - 3:00 pm Sundays: June 9, 23, July 14, 28, Aug 11, 17.  Make-up, if needed, Aug 25.  Meets 6 times plus final exam.
Faculty:  Andrew Fletcher
Required text: (1) The Merck Manual of Diagnosis & Therapy, 19th ed online (free) at www.merckmanuals.com or optionally the hard-copy edition, The Merck Manual of Diagnosis & Therapy (19th ed), 2011, (ISBN: 10:0911910190 or ISBN 13:978-0911910193).  You may also refer to the Home Edition (same website), if you are having difficulty with the professional edition, AND 2) The Demon in the Freezer, Richard Preston, Ballantine Books, NY, 2003, (ISBN:  10-0-345-46664-2).
Formerly Pharmaceutics 599.  Not open to students who have taken Pharmaceutics 599.

5491.  Pre-Approval Inspections (111)  crn:  4140
9:00 am - 3:30 pm Saturdays (1/2 hour lunch):  June 8, 22, July 13, 27, Aug 10, 17.  Meets 6 times plus final exam.  Make-up, if needed, Aug 24.  In-class, proctored exam:  July 27.
Faculty:  John Parker
Required text:  Pharmaceutical Pre-Approval Inspections:  A Guide to Regulatory Success, Martin D. Hynes,  2nd edition, 2008, (ISBN:  13: 978-0-8493-9184-2, ISBN: 10: 0-8493-9184-9).
Formerly Pharmaceutics 490.  Not open to students who have taken Pharmaceutics 490.

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The following courses have already started. If they have just met once, it is still possible to register for them. Check with the QA/RA Office to see if a recording of the first class is available and if there is space in the course:

5408. Pharmacoeconomics (990) crn: 4257. There is a section of Pharmacoeconomics in an online, real-time format on Wednesday nights. Please see the Online Course Schedule for more information.

5458.  The Global Biopharmaceutical Company (including Waxman Hatch) (111)  crn: 4132
Prerequisite:  Drug Development (Pharmaceutics 5459). To learn more about this course: http://qara-apache.temple.edu/BBerger/BB5458.html
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  May 18, June 1, 8, 22, 29, July 13.  Meets 6 times plus final exam.  Make-up, if needed, July 20.  In-class, proctored exam:  June 22.
Faculty:  Barry Berger
Required text: The Generic Challenge:  Understanding Patents, FDA, and Pharmaceutical Life-Cycle Management, Martin Voet, Brown Walker Press, 3rd ed., 2011 ( ISBN:  10:1599425769 or 13:978-1599425764).

5459. Drug Development (111)  crn:  1157 
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  May 18, June 1,  8, 22,  29, July 13.  Meets 6 times plus final exam.  Make-up, if needed, July 20.  In-class, proctored exam:  June 22.  
Faculty:   Peter Smith
Required texts: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN:1-882615-85-9).
Recommended text: Drugs: From Discovery to Approval, Ng, 2nd ed, 2009 (ISBN-10: 0-470-19510-X or ISBN-13: 978-0-470-19510-9).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5459. Drug Development (112)  crn:  902 
6:00 pm - 9:30 pm Wednesdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24, 31 (final exam).  Meets 10 times plus proctored, in-class final on July 31.  No class July 3.  Make-ups, if needed, Aug 7 or 14.  In-class, proctored midterm and final:  June 19 and July 31.
Faculty:  Frank Diana
Required text:  New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

TARRYTOWN, NY

5459.  Drug Development (318)  crn: 4134
This course meets in Tarrytown, NY, by the Tappan Zee Bridge.
8:30 am - 5:00 pm Saturdays (1 hour lunch):  May 18, June 1, 15, 29, July 13.  Meets 5 times.  Make-up, if needed, July 27.  In class, proctored exams:  June 15 and July 13
Faculty:  Lionel Edwards
Required text:  Principles and Practice of Pharmaceutical Medicine, Edwards, Fox, and Stonier, 3rd ed, (ISBN 9781405194723).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5459. Drug Development (990) crn: 5601. There is a section of Drug Development in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

5472. Pharmaceutical Marketing (990) crn: 4158. There is a section of Pharmaceutical Marketing in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

5477.  Good Manufacturing Practices (111) crn: 884
8:30 am – 3:00 pm  Sundays (1/2 hr lunch): May 19, June  2, 9, 23, 30, July 14.  Meets 6 times.  Make-up, if needed, July 21.  In-class exam:  June 23.
Faculty:  Bev Zaber
No required text.
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5477. Good Manufacturing Practices (990) crn: 4136. There is a section of Good Manufacturing Practices in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5479. Advanced GMPs - defining "c" (990) crn: 2494. There is a section of Advanced GMPs - defining "c" in an online, real-time format on Thursday nights. Please see the Online Course Schedule for more information.

5491.  Pre-Approval Inspections (111)  crn:  4140
9:00 am - 3:30 pm Saturdays (1/2 hour lunch):  June 8, 22, July 13, 27, Aug 10, 17.  Meets 6 times plus final exam.  Make-up, if needed, Aug 24.  In-class, proctored exam:  July 27.
Faculty:  John Parker
Required text:  Pharmaceutical Pre-Approval Inspections:  A Guide to Regulatory Success, Martin D. Hynes,  2nd edition, 2008, (ISBN:  13: 978-0-8493-9184-2, ISBN: 10: 0-8493-9184-9).
Formerly Pharmaceutics 490.  Not open to students who have taken Pharmaceutics 490.

5494. Quality Audit (990) crn: 4137. There is a section of Quality Audit in an online, real-time format on Thursday nights. Please see the Online Course Schedule for more information.

5495.  IND/NDA Submissions (111)  crn: 4162
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law (Pharmaceutics 5592).
5:00 pm - 8:30 pm Thursdays:  May 23, 30, June 6, 13, 20, 27, July 11, 18, 25, Aug 1.  Meets 10 times plus final exam.  Make-ups, if needed, Aug 1 or 8.  Proctored, in-class exam: June 20.  No class July 4.
Faculty: Peter Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Formerly Pharmaceutics 495.  Not open to students who have completed Pharmaceutics 495.

5495. IND/NDA Submissions (990) crn: 2531. There is a section of IND/NDA Submissions in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5496. Regulation of Medical Devices: Compliance (990) crn: 4138. There is a section of Regulation of Medical Devices: Compliance in an online, real-time format on Wednesday nights. Please see the Online Course Schedule for more information.

5505. Global Medical Device Regulation (990) crn: 2351. There is a section of Global Medical Device Regulation in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5516. Cleaning Validation (990) crn: 3422. There is a section of Cleaning Validation in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

5536.  Good Clinical Practices (111)  crn:  4135
8:30 am - 3:00 pm Sundays (1/2 hour lunch):  May 19, June 2, 9, 30, July 14, 21.  Meets 6 times plus final exam.  Make-up, if needed, July 28. Proctored, in-class exam: July 21.
Faculty:  Nancy Smith
No required text.
Formerly Pharmaceutics 536.  Not open to students who have completed Pharmaceutics 536.

5536.  Good Clinical Practices (990)  crn: 3423 There is a section of Good Clinical Practices in an online, real-time format on Wednesday nights. Please see the Online Course Schedule for more information.

5537.  Clinical Trial Management (111)  crn: 4174
5:30 pm - 9:00 pm Tuesdays:  May 14, 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23.  Meets 10 times plus final exam on July 23.  Make-up, if needed, July 30.  Proctored, in-class exam:  July 23.
Faculty:  Michael McGraw
Required text: Principles of Good Clinical Practice, McGraw, George, Shearn, Hall, Haws (editors), Pharmaceutical Press, July 2010, (ISBN-10:0853697906, ISBN-13:978-0853697909). 
Formerly Pharmaceutics 537.  Not open to students who have completed Pharmaceutics 537.

5546. Global Pharmaceutical Excipient Regulation (990) crn: 4139. There is a section of Global Pharmaceutical Excipient Regulation in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

5571.  Post Marketing Safety Surveillance (111)  crn: 3415
This course may be taken at Temple U Fort Washington in a traditional classroom setting, or it may also be taken online.  For the online version, please see the Online Course Schedule.
6:00 pm - 9:00 pm Mondays:  May 13, 20, June 3, 10, 17, 24, July 1, 8, 15, 22, 29, Aug 5, 12.  Meets 12 times plus proctored, final exam on Aug 12.  No class May 27 (Memorial Day).  Make-ups, if needed, Aug 19 or 26.  Proctored exam: Aug 12.
Faculty:  Don Wallace
Required text:  Practical Aspects of Signal Detection in Pharmacovigilance, CIOMS Group VIII, 2010,
http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=84&codcch=30
Optional text: Pharmacovigilance, Andrews and Mann, 2007, Wiley & Sons, Inc., (ISBN: 0470018038).
Formerly Pharmaceutics 571.  Not open to students who have taken Pharmaceutics 571.

5576.  Global CMCs and the Regulatory Dossier (111)  crn:  3417 
Suggested prerequisites: Drug Development (Pharmaceutics 5459), IND/NDA Submissions (Pharmaceutics 5495), and Global Regulatory Affairs (Pharmaceutics 5591), or fax resume to 267.468.8565.
6:00 pm - 9:30 pm Wednesdays:  May 15, 22, 29, June 5, 12, 19, 26, July 10, 17, 24.  Meets 10 times plus final exam.  Make-ups, if needed, July 31 or Aug 7.  Proctored, in-class exam:  June 19.   No class July 3. 
Faculty:  Sandeep Modi
No required text.
Formerly Pharmaceutics 586.  Not open to students who have taken Pharmaceutics 586.

5591. Global Regulatory Affairs (990) crn: 1733. There is a section of Global Regulatory Affairs in an online, real-time format on Thursday nights. Please see the Online Course Schedule for more information.

5592.  Food and Drug Law I  (111)  crn:  126 
6:00 pm – 9:30 pm Tuesdays: May 21, 28, June 4, 11, 18, 25, July 2, 9, 16, 23.  Meets 10 times.  Make-ups, if needed, July 30. In-class, proctored midterm:  June 18.
Faculty: Barry Berger
Required texts: Food and Drug Law: Cases and Materials, 3rd edition, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4). Order the 2007 edition and not earlier versions;  AND FDCA Statutory Supplement, (ISBN:  978-1-935065-01-2).Order Supplement from www.fdli.org.  FDLI gives QA/RA students a discount, if they order the Supplement from FDLI’s Customer Service Department by phone (1-800-956-6293) or fax(202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete your transaction on-line, or you will be charged the non-member price.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (112)  crn: 2520 
8:30 am – 3:00 pm Sundays  (1/2 hour lunch):  May 19, June 2, 16, 30, July 21, Aug 4.  Meets 6 times plus final exam.  Make-up, if needed, Aug 18.  Proctored exams:   June 16 and July 21.
Faculty:  Craig Hammes
Required texts:  1) Food and Drug Law:  Cases and Materials, 3rd edition, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).   Order the 2007 edition and not earlier versions;  and 2) FDCA Statutory Supplement, (ISBN:  978-1-935065-01-2).Order Supplement from www.fdli.org.  FDLI  gives QA/RA students a student discount, only if they order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or fax(202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete your transaction on-line, or you will be charged the prices listed for non-members.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592. Food and Drug Law I (990) crn: 1734. There is a section of Food and Drug Law I in an online, real-time format on Wednesday nights. Please see the Online Course Schedule for more information.

5596. Food Labeling and Regulatory Affairs (990) crn: 4160. There is a section of Food Labeling and Regulatory Affairs in an online, real-time format on Thursday nights. Please see the Online Course Schedule for more information.

 

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 Or, phone: 1.800.325.3252

Drop/Add Policy

To receive a complete refund for a course, you must notify the QA/RA 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
QA/RA Graduate Program

425 Commerce Drive, Suite 175
Fort Washington, PA  19034-2713
Phone: 267.468.8560
E-Mail:
qara@temple.edu