Spring 2013 Schedule of Classes (Updated Feb 19, 2013)

Drop/Add Policy

 

5477.  Good Manufacturing Practices (318) crn: 20654
This class meets in Tarrytown, NY.
8:30 am – 5:00 pm Saturdays (1 hour lunch):  Feb 2, 23, Mar 9, 23, Apr 13.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 27 or May 4.  Proctored, in-class exam:  Mar 9 .
Faculty:  Carmella Ditmars
Optional text: Good Manufacturing Practices for Pharmaceuticals, 6th ed, Nally (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5408.  Pharmacoeconomics (101) crn: 20651 Room 4
6:00 pm – 9:30 pm Thursdays: Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28.  Meets 10 times plus final exam on April 4.  Make-up, if needed, Apr 11.  Proctored, in-class exam: April 4.
Faculty:  Albert Wertheimer
Required text: Principles of Pharmacoeconomics, J. L. Bootman, R. J. Townsend, W. F. McGhan, 3rd ed.
Formerly Pharmaceutics 480.  Not open to students who have taken Pharmaceutics 480.

5459. Drug Development (101) crn: 7314 Room 19
6:15 pm – 9:45 pm Thursdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28.  Meets 10 times plus final exam on Apr 4.  Make-up dates, if needed, Apr 11 or 18.  Proctored in-class exam: April 4.
Faculty:  Sandra Cottrell
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.

5459. Drug Development (990) crn: 7447. 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.

5459.  Drug Development (102) crn: 7315 Room 13
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Jan 19, Feb 2, Mar 2, 16, Apr 6, 20.  Meets 6 times plus final exam.  Make-up, if needed, Apr 27 or May 4.  Proctored, in-class exam:  Mar 16.
Faculty:  Peter Smith
Required text: Drugs:  From Discovery to Approval, Ng, 2nd ed, Dec 2008, Wiley-Blackwell, (ISBN: 978-0-470-19510-9); Recommended text: New Drug Development: A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9).
Formerly Pharmaceutics 459.  Not open to students who have completed Pharmaceutics 459.

5472. Pharmaceutical Marketing (990) crn: 20665. There is a section of Pharmaceutical Marketing in an online, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5473. Generic Drug Regulation: ANDAs (990) crn: 12424. There is a section of Generic Drug Regulation: ANDAs in an online, real-time format on Thursday nights.  Please see the Online Course Schedule for more information.

5477.  Good Manufacturing Practices (101) crn:  7453 Room 13
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17, Apr 7.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored, in-class exam:  Mar 3.
Faculty:  Frank Stevenson
Optional text: Good Manufacturing Practices for Pharmaceuticals, 6th ed, Nally (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

TARRYTOWN, NY:
5477.  Good Manufacturing Practices (318) crn: 20654
This class meets in Tarrytown, NY.
8:30 am – 5:00 pm Saturdays (1 hour lunch):  Feb 2, 23, Mar 9, 23, Apr 13.  Meets 5 times plus final exam.  Make-up, if needed, May 11.  Proctored, in-class exam:  Mar 9 .
Faculty:  Carmella Ditmars
Optional text: Good Manufacturing Practices for Pharmaceuticals, 6th ed, Nally (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5477. Good Manufacturing Practices (990) crn: 3439. There is a section of Good Manufacturing Practices in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5494.  Quality Audit (101)  crn:  20674 Room 4
Prerequisite:  a good practices course (either Pharmaceutics 5476, 5477, 5479 or 5536).
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17 (tentative), Apr 7.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored, in-class exam:  Mar 3.
Faculty:  Teresa Preziosi
Required text: The ASQ Auditing Handbook, 3rd  ed, J.P. Russell.  Available from ASQ Quality Audit Division:  www.asq.org  (ISBN:  9780873896665, ASQ Item 1263).
Formerly Pharmaceutics 494.  Not open to students who have taken Pharmaceutics 494.

5495. IND/NDA Submissions (990) crn: 20675. There is a section of IND/NDA Submissions in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5501.  Development of Sterile Parenterals (101) crn:  20672 Room 3
6:00 pm – 9:30 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1. Meets 10 times plus final exam.  Make-ups, if needed, Apr 8 or 15.  Proctored, in-class exam: Mar 4.
Faculty:  Dan Casaburi
No required text.
Formerly Pharmaceutics 501.  Not open to students who have completed Pharmaceutics 501.
Science background required.

5502. Medical Device Regulation: Submissions (990) crn: 20666. There is a section of Medical Device Regulation: Submissions in an online, real-time format on Monday nights.  Please see the Online Course Schedule for more information.

5513. Active Pharmaceutical Ingredients (APIs) (990) There is a section of Active Pharmaceutical Ingredients (APIs) in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 20655. There is a section of Biologics/Biosimilars: A Regulatory Overview in an online, real-time format on Tuesday nights.  Please see the Online Course Schedule for more information.

5532.  Global Labeling Regulation:  Principles and Practices (101) crn:  20658 Room 3
Prerequisite:  either Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
8:30 am – 3:00 pm Saturdays (1/2 hour lunch): Jan 26, Feb 23, Mar 9, 23, Apr 13, 27.  Meets 6 times plus final exam.  Make-up, if needed, May 4.  Proctored, in-class exam:  to be announced. Either Mar 9 or 23. No class Feb 9 due to snow.
Faculty:  Barbara Fanelli and Gerrit Jan-Nijeldt
No required text.

5534.  Regulatory Aspects of Biomedical/Technical Communication (101) crn: 20749 Room 13
To learn more: http://qara-apache.temple.edu/Fletcher/AF5534.htm
8:30 am – 5:00 pm Sundays (1 hours lunch):  Jan 27, Feb 10, 24, Mar 10, 24.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 14 or 28.  Proctored, in-class exam:  Feb 24.
Faculty:  Andrew Fletcher
Required text:  Handbook of Technical Writing,  Gerald J. Alred, Charles T. Brusaw, Walter E. Liu, 10th ed (hardcover), St Martin’s Press, (ISBN:  10: 1250004411, SBN 13:978-1250004413.  For more details:  www.amazon.com/Handbook-Technical-Writing-Tenth-Edition/dp/1250004411.
Formerly Pharmaceutics 534.  Not open to students who have taken Pharmaceutics 534.

5536.  Good Clinical Practices (101)  crn:  20656 Room 19
8:30 am – 5:00 pm (1 hr lunch)  Saturdays:  Jan 26, Feb 23, Mar 9, 23, April 13.  Meets 5 times.  Make-up, if needed, April 20.  Proctored midterm and final (probably Mar 9 and April 13). No class Feb 9 due to snow.
Faculty:  Lionel Edwards
Required text:  Principles and Practice of Pharmaceutical Medicine, Edwards, Fox, and Stonier, 3rd ed, (ISBN 9781405194723).
Formerly Pharmaceutics 536.  Not open to students who have completed Pharmaceutics 536.

FRAZER:
5536.  Good Clinical Practices (110) crn:  20657
This course meets at the Cambridge Room (lower level) of the Sheraton Great Valley, 707 E. Lancaster Ave, Frazer, PA  19355.  Phone: 610-524-5500.
6:00 pm – 9:30 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 11 times (includes final exam). Make-up, if needed, Apr 16.  Proctored, in-class exam: Apr 9. No class Feb 26.
Faculty:  Michael McGraw
Required text: Principles of Good Clinical Practice, McGraw, George, Shearn, Hall, Haws (eds), Pharmaceutical Press, July 2010, (ISBN-10:0853697906, ISBN-13:978-0853697909). 
Formerly Pharmaceutics 536.  Not open to students who have taken Pharmaceutics 536.

5537. Clinical Trial Management (990) crn: 20667. There is a section of Clinical Trial Management in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5544.  Regulatory Intelligence (101) crn: 20795 Room 19
Prerequisites: Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592).
8:30 am – 5:00 pm Sundays (1 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 7 and 21.  Proctored, in-class quizzes:  Feb 17 and Mar 3.
Faculty:  Linda Bowen
No required text.

5545. Post Approval Changes (990) crn: 20668 There is a section of Post Approval Changes in an online, real-time format on Wednesday nights.  Please see the Online Course Schedule for more information.

5547. Project Management for Clinical Trials (990) crn: 20669 There is a section of Project Management for Clinical Trials in an online, real-time format on Tuesday nights.  Please see the Online Course Schedule for more information.

5574.  Pharmaceutical Quality Systems Management (101) crn:  20659 Room 4
6:00 pm – 9:30 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26.  Meets 10 times plus fine exam.  Make-ups, if needed, Apr 2 or 9.  Proctored, in-class exam:  Feb 26.
Faculty:  Michael LaBruto
Required text:  Quality Systems and Control for Pharmaceuticals, Sarkar, Dipak, K., 2008 (ISBN:  0789015838).

5575. Regulatory Sciences: Managing the Guidelines to Quality (990) crn: 12430 There is a section of Regulatory Sciences: Managing the Guidelines to Quality in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5578. Risk Managment and Safety Signaling of Healthcare Products (990) crn: 8723. There is a section of Risk Management and Safety Signaling of Healthcare Products in an online, real-time format on Thursday nights. Please see the Online Course Schedule for more information.

5591. Global Regulatory Affairs (990) crn: 20671. There is a section of Global Regulatory Affairs in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

5592.  Food and Drug Law I (101)  crn:   2190 Room 3
To learn more: http://qara-apache.temple.edu/hammes/chfdlaw.html
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17, Apr 7.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 21 or 28.  Proctored, in-class exam:  Mar 3.
Faculty:  Craig Hammes
Note:  Since this class only meets 6 times, there is required reading for the first class.  Please purchase the textbooks in advance and bring them to class. Read pp 1 – 27 of Hutt’s Food and Drug Law:  Cases and Materials. Please also download the U.S. Constitution and bring it to the first class.
Required texts:  1) Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Make sure you purchase the 2007 edition (and not earlier editions); and 2) FDCA Statutory Supplement, (ISBN: 978-1-935065-54-8).Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you 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 (102)  crn: 20660 Room 19
To learn more:  http://qara-apache.temple.edu/BBerger/BBFDLaw1.html
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Jan 19, Feb 2, 16, Mar 2, 16, Apr 6.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 20 or 27.  Proctored exam:  Mar 2.
Faculty:  Barry Berger
Required texts: 1) Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Make sure you purchase the 2007 edition (and not earlier editions);  and 2) FDCA Statutory Supplement, (ISBN:  978-1-935065-54-8).  Note:  a used 2008 or later edition of the FDCA Statutory Supplement is also acceptable. Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or via fax (202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete the transaction online, or you will be charged non-member prices.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (103)  crn: 9956 Room 19
6:00 pm – 9:30 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 8 or 15.  Proctored, in-class exam:  Apr 1.
Faculty:  Brian Bollwage
Required text: Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4). Make sure you purchase the 2007 edition (and not earlier editions).   
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592. Food and Drug Law I (990) crn: 7202. 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.

5605.  Advanced Topics in Food and Drug Law (101) crn: 20661 Room 13
Prerequisite:  Food and Drug Law I (Pharmaceutics 5592 or permission of QA/RA Office (fax resume to 267.468.8565).
6:00 pm – 9:30 pm Mondays:  Jan 28, Feb 4, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1, 8. Meets 10 times plus final exam.  Make-up, if needed, Apr 15.  Proctored, in-class exam: Apr 8. No class Feb 11.
Faculty:  Barry Berger
Required texts: 1) Food and Drug Law:  Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  Make sure you purchase the 2007 edition (and not earlier editions); FDCA Statutory Supplement, (ISBN:  978-1-935065-54-8).  Note:  a used copy of the 2008 or later FDCA Statutory Supplement is also acceptable. Order Supplement from www.fdli.org.  FDLI gives QA/RA students a special student discount, only if you order the Supplement by phone from FDLI’s Customer Service Department (1-800-956-6293) or via fax (202-371-0649).  You must include a copy of your Temple QA/RA schedule.  Do not complete the transaction online, or you will be charged non-member prices.
Formerly Pharmaceutics 605.  Not open to students who have completed Pharmaceutics 605.

5601. Industry Interactions with FDA and Health Authorities (990) crn: 5601. There is a section of Industry Interactions with FDA and Health Authorities in an online, real-time format on Monday nights. Please see the Online Course Schedule for more information.

5612.  Bioethics for Pharmaceutical Professionals (101) crn: 20662 Room 3
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17, Apr 7.  Meets 6 times plus final exam.  Make-ups if needed, Apr 21 or 28.  Proctored, in-class exam:  Mar 3.
Faculty:  Sean Develin
Required text: The Singularity is Near, Kurzweil, Penguin Books (ISBN:  0-14-303788-9).
Formerly Pharmaceutics 610.  Not open to students who have completed Pharmaceutics 610.

5615.  Project Management (101)  crn: 20663 Room 4
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Jan 19, Mar 2, 16, Apr 6, 20, 27.  Meets 6 times plus final exam.  (No class Feb 16.) Make-up, if needed, May 4.  Proctored, in-class exam:  Mar 16.
Faculty:  Carmella Ditmars
Required text: A Guide to the Project Management Body of Knowledge, (PMBOK@Guide).  Order through www.pmi.org.  Be sure to order the latest edition.
Formerly Pharmaceutics 615.  Not open to students who have taken Pharmaceutics 615.

5622.  Unit Operations (101) crn:  20664 Room 13
This is a hybrid course, which means that some lectures will be posted online but other meetings require students to attend in person (including one or two field trips to Emerson Resources, where students will practice milling, mixing, tableting and coating.) Please reserve all of the listed date.  We will post additional information when it is available.  Emerson Resources is located at 600 Markley St, #1, Norristown, PA  19401. Other weekend dates meet at Temple U Fort Washington.
8:30 am – 3:00 pm Saturdays (1/2 hour lunch):  Meets as follows: in-class meetings at Ft Washington:  Jan 26, Feb 23, Apr 6.  Required all-day field trips to Emerson:  Mar 9 and 23. Students are also required to watch recordings that will be available on the Internet will be posted on Feb 2, 9, 16, Mar 16 and 30. Proctored in-class exam:  Apr 13. Make-ups, if needed, Apr 27 or May 4.
Faculty:  David Lebo
Prerequisite:  Strong science background, including a BS in pharmacy, chemistry, biology, or engineering and familiarity with chemistry, biology, and physics.  Students should also have a basic understanding of pharmaceutical manufacturing processes.

5627.  Statistical Design of Experiments (101) crn: 12422 Room 3
8:30 am – 3:00 pm Sundays (1/2 hour lunch):  Jan 27, Feb 10, 24, Mar 10, 24, Apr 14.  Meets 6 times.  Make-ups, if needed, Apr 28 or May 5.  Proctored, in-class exams, on Mar 10 and Apr 14.
Faculty:  Ronald Snee
Required text: Design and Analysis of Experiments, D Montgomery, 2012, 8th ed, (ISBN:  9781118214718.)

NON-THESIS SECTIONS (01235)

Electives from the non-thesis MS in Pharmaceutics are open to QA/RA students who have strong science backgrounds. This consists of a minimum of 2 years of general chmistry, including organic and one analytical chemistry course. Students must fax their resume to 267.468.8565 for written permission to register.

5501.  Development of Sterile Parenterals (101) crn:  20672 Room 3
6:00 pm – 9:30 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1. Meets 10 times plus final exam.  Make-ups, if needed, Apr 8 or 15.  Proctored, in-class exam: Mar 4.
Faculty:  Dan Casaburi
No required text.
Formerly Pharmaceutics 501.  Not open to students who have completed Pharmaceutics 501.

8005.  Pharmaceutical Biotechnology (990) crn:  20673 There is a section of Pharmaceutical Biotechnology in an online, real-time format on Tuesday nights. Please see the Online Course Schedule for more information.

8007.  Applied Biopharmaceutics (101) crn:  7327 Room 4
5:30 pm – 8:30 pm Wednesdays:  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 24 or May 1.  Proctored, in-class exam:  Apr 17.
Faculty:  Reza Fassihi
No required text.
Formerly Pharmaceutics 410.  Not open to students who have completed Pharmaceutics 410.

 

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

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QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

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Order texts on-line via: Virtual Bookstore
 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