QA/RA Online Course Schedule – Spring 2013 (updated 2/19/13)


Notes:
You must purchase a headset with a built-in microphone for all online courses, and you must test the headset for compatibility with the Adobe Connect and/or WebEx systems.

We also require webcams, since they enhance student presentations and help you to get to know other students in your class.

You must have any stated prerequisites to register for Online courses.

All students new to Temple QA/RA Online courses must watch:   http://breeze.temple.edu/p59716030. A password is given at the end, which must be included on the registration form. We will not process registration forms that do not have the password.  If you have previously taken a Temple U QA/RA online course, you do not need to take the self-test of Adobe, unless you have recently changed laptops or computers. If you plan to use a different computer, please be considerate of other members in your class and TEST your new computer BEFORE starting a class.

All Online courses have limited seats. Registration is first-come, first-served.

Please make sure you review and understand the SOPs for proctoring in online courses. This includes agreeing to take your midterm or final during the window of 3:00 pm - 9:00 pm on the designated exam date (no exceptions). Due to University academic policies, the QA/RA Office will not alter exam times or dates, so please adjust your schedule accordingly for the proctored exam in your course. For more on Proctoring, click here.

New students: Please remember to include a copy of your resume, the state residency form, copies of college transcripts, and TOEFL scores and WES reports (if applicable) with your initial Adobe Connect/WebEx registration. Starting this semester, we are also requiring new students to submit a recent photograph of themselves for identification purposes. This can be submitted hard copy or electronically.

CLASSES ARE LISTED IN EAST COAST TIMES (please adjust according to your time zone).

Spring 2013 - Semester begins January 19, 2013

 

5459. Drug Development  (990) crn: 7447 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, 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 19.
Faculty:  Dan Walsh
Three required texts:  1) New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN: 1-882615-85-9);  2) Drugs:  From Discovery to Approval, Ng, 2nd ed, Dec 2008, Wiley-Blackwell, (ISBN: 978-0-470-19510-9); AND 3) The Great Influenza:  The Epic Story of the Deadliest Plague in History, John M. Barry, Penguin Group, Oct 2005, (ISBN: 13-9780143036494).
Formerly Pharmaceutics 459.  Not open to students who have taken Pharmaceutics 459.

5472.  Pharmaceutical Marketing (990) crn:  20665 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Thursdays:  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.
Faculty:  Doug Hisey
Tentative required text: Pharmaceutical Marketing:  Principles, Environment and Practice, Smith, (ISBN:  0789015838).
Formerly Pharmaceutics 482.  Not open to students who have taken Pharmaceutics 482.

5473.  Generic Drug Regulation: ANDAs (990) crn: 12424 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459).
6:00 pm – 9:00 pm Thursdays:  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:  Cindy Ciliberto
No required text.
Formerly Pharmaceutics 483.  Not open to students who have taken Pharmaceutics 483.

5477.  Good Manufacturing Practices (990) crn: 3439 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
6:00 pm – 9:00 pm Wednesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, April 10, 17.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 24 or May 1. No class Apr 3.
Proctored exam:  Feb 27. 
Faculty:  Evan Boswell
Required text: Good Manufacturing Practices for Pharmaceutics, McNally, 6th ed, (ISBN:  0-8493-3972-3).
Formerly Pharmaceutics 487.  Not open to students who have taken Pharmaceutics 487.

5495.  IND/NDA Submissions (990)  crn: 20675 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. CLOSED. WAIT LIST ONLY.
Special note:  this course will use a new, online proctoring device known as Software Secure.  The device will be loaned to students for the semester for free but must be returned to the QA/RA Office before final grades will be released.  All exams for the course must be taken on this device.  If you do not wish to participate in the online proctoring trial, please do not sign up for this course.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 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 17 or 24.  Proctored exam:  Mar 6.
Faculty:  Alexa Smith
Required text:
Formerly Pharmaceutics 495.  Not open to students who have completed Pharmaceutics 495.

5502.  Medical Device Regulation:  Submissions (990) crn:  20666 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm  Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1, 8, 15.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 22 or 29.  Proctored exam:  Mar 11.
Faculty:  Marcia Arentz
No required text.
Formerly Pharmaceutics 500.  Not open to students who have taken Pharmaceutics 500.

5513.  Active Pharmaceutical Ingredients (APIs) (990) crn: 20741 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459) or special permission (fax resume to 267.468.8565).
7:00 pm – 10:00 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1, 8, 15.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 22 or 29.  Proctored exam:  Mar 11.
Faculty:  Karen Zimm
No required text.

5515.  Biologics/Biosimilars:  A Regulatory Overview (990) crn: 20655 Expectations of Online Students. You must use the Registration Form for Online Courses for this class. Closed. Wait List Only.
Prerequisite:  Drug Development (Pharmaceutics 5459) and Food and Drug Law I (Pharmaceutics 5592).  Students should have a science background, including familiarity with undergraduate chemistry and biology. Fax resume to 267.468.8565.
6:00 pm – 9:00 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, 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:  Frank Diana
No required text.

5537.  Clinical Trial Management (990)  crn:  20667 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Good Clinical Practices (5536) or special permission of the QA/RA department (fax resume to 267.468.8565).
6:00 pm – 9:00 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 17 or 24. Proctored exam:  March 6.
Faculty:  Joseph Scavone
No required text.
Formerly Pharmaceutics 537.  Not open to students who have taken Pharmaceutics 537.

5545.  Post Approval Changes (990)  crn:  20668 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Special note:  this course will use a new, online proctoring device known as Software Secure.  The device will be loaned to students for the semester for free but must be returned to the QA/RA Office before final grades will be released.  All exams for the course must be taken on this device.  If you do not wish to participate in the online proctoring trial, please do not sign up for this course.
7:00 pm – 10:00 pm Wednesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, April 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24.  Proctored exam:  Mar 6. 
Faculty:  Karen Zimm
No required text.
Formerly Pharmaceutics 545.  Not open to students who have taken Pharmaceutics 545.

5547.  Project Management for Clinical Trials (990) crn:  20669 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisites:  Drug Development (Pharmaceutics 5459) and Clinical Trial Management (Pharmaceutics 537).
6:00 pm – 9:00 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 23 or 30.  Proctored exam: Apr 16.
Faculty:  Jeffrey Sheldon
Required text:  Project Management for the Pharmaceutical Industry, June 2011, Revised Reprint, ISBN:  978-1-4094-1894-8.

5575.  Regulatory Sciences:  Managing the Guidelines to Quality (990) crn:  12430 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  strong science background or permission of QA/RA Office.  Fax resume to 267.468.8565.
6:00 pm – 9:00 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 11, 18, 25 (Passover), Apr 1, 8, 15.  Meets 12 times plus final exam. Make-ups, if needed, Apr 22 or 29.  Proctored exam:  Apr 22.
Faculty:  Thomas Schultz
No required text.
Formerly:  Pharmaceutics 575.  Not open to students who have taken Pharmaceutics 575.

5578.  Benefit Risk Management and Safety Signaling of Healthcare Products (990)  crn:  8723 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Thursdays:  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: Apr 18.
Faculty:  John Clark and Islah Ahmed
Required text:  A Framework for Pharmaceutical Risk Management, Fetterman, Nickel, Pines, Slatko.
Prerequisites:  Students should have completed one of the following courses or must receive special permission from the QARA Office (fax resume to 267-468-8565): Post Marketing Safety Surveillance (Pharmaceutics 5571), or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538), or Good Pharmacovigilance Operations (Pharmaceutics 5508), or 4) Pharmacoepidemiology (Pharmaceutics 5573).

5579.  Regulatory and Legal Basis of Pharmacovigilance (990) crn:  20670 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Suggested prerequisite:  one Pharmacovigilance course: Post Marketing Safety Surveillance (Pharmaceutics 5571) or Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538) or Good Pharmacovigilance Operations (Pharmaceutics 5508) or Benefit-Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578).
6:00 pm – 9:00 pm Wednesdays: Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, April 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 24 or May 1. Proctored exam:  Apr 17.
Faculty:  Don Wallace 
Suggested text:  Pharmacovigilance, Ronald D. Mann, Elizabeth B. Andrews, 2007, John Wiley & Sons, 2nd ed.

5591.  Global Regulatory Affairs (990) crn: 20671 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
Prerequisite:  Drug Development (Pharmaceutics 5459) or Food and Drug Law I (Pharmaceutics 5592).
6:00 pm – 9:00 pm Tuesdays:  Jan 22, 29, Feb 5, 12, 19, 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.
Faculty:  Daniel Larkins
No required text.
Formerly Pharmaceutics 591.  Not open to students who have completed Pharmaceutics 591.

5592.  Food and Drug Law I (990) crn: 9424 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
To learn more: https://breeze.temple.edu/p11528886/
6:00 pm – 9:00 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 17 or 24.  Proctored exam:  Feb 27.
Faculty:  Gail Pilgrim
Required text: Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978-
1-58778-068-4). Order the 2007 edition and not earlier versions.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5592.  Food and Drug Law I (991) crn:  20825 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Wednesdays:  Jan 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10, 17.  Meets 12 times plus final exam.  Make-up, if needed, Apr 24.  Proctored exam: Mar 13. Note: Jan 23rd class cancelled, so course started on Jan 30th.
Faculty: Mary Dronitsky
Required text: Food and Drug Law: Cases and Materials, 3rd ed, Hutt, et al, Foundation Press, 2007, (ISBN: 978- 1-58778-068-4). Order the 2007 edition and not earlier versions.
Formerly Pharmaceutics 592.  Not open to students who have taken Pharmaceutics 592.

5596. Food Labeling and Regulatory Affairs (990) crn: 20801 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Thursdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, Apr 4, 11, 18.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 25 or May 1.  Proctored exam: Apr 25.
Faculty:  Kirk Sooter
Required text: to be announced.

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. CLOSED. WAIT LIST ONLY.
6:00 pm – 9:00 pm Mondays:  Jan 28, Feb 4, 11, 18 (Presidents’ Day), 25, Mar 4, 18, 25 (Passover), Apr 1, 8, 15, 22.  Meets 12 times plus final exam.  Make-up, if needed, Apr 29.  Proctored exam:  Mar 18. No class Mar 11.
Faculty:  Alan Traettino
Required text:
Formerly Pharmaceutics 601.  Not open to students who have completed Pharmaceutics 601.

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 chemistry, including organic and one analytical chemistry course.  Students must fax their resume to 267.468.8565 for written permission to register.

8005.  Pharmaceutical Biotechnology (990) crn:  20673 Expectations of Online Students. You must use the Registration Form for Online Courses for this class.
6:00 pm – 9:00 pm Tuesdays:  Jan 22, 29, Feb 12, 19, 26, Mar 5, 12, 19, 26, Apr 2, 9, 16.  Meets 12 times plus proctored final exam.  Make-ups if needed, Apr 23 or 30.  No class Feb 5.  Proctored midterm:  Mar 5.
Faculty:  Tom Parry
Required text:  Pharmaceutical Biotechnology:  Fundamentals and Applications, Crommelin, Sindelar & Meibohm, eds, 3rd ed, Informa Healthcare 2007 (ISBN-10:  1420044370, ISBN-13 978-1420044379). Paperback recommended.
Suggested text: Biopharmaceuticals:  Biochemistry and Biotechnology, Walsh, G., 2nd ed, Wiley, West Sussex, England, 2003, $76.50, (ISBN 0-470-84327-6). Students should also have access to textbooks in biochemistry and/or molecular biology from previous courses.
Formerly Pharmaceutics 475.  Not open to students who have taken Pharmaceutics 475.

 

line

Students MUST use the Registration Form for Online Courses for Online Courses.

How to Register

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

Is this your fourth class with the QA/RA 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
QA/RA Graduate Program
425 Commerce Drive, Suite 175
Ft. Washington, PA 19034

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.

RETURN TO QA/RA HOMEPAGE

RETURN TO QA/RA SCHEDULE OF CLASSES

 
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