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

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Spring 2018 Schedule for the Regulatory Affairs and Quality Assurance Graduate Program

On-Campus Courses Only (listed numerically by Course Number) (updated December 6, 2017)


Please check class dates carefully. Students who cannot make the scheduled exam date will be charged a $20.00 fee for an initial makeup exam. In subsequent semesters, the fee increases to $30.00 per exam. For more on this policy, click here.

To comply with U.S. visa requirements, full-time international students must take on-campus courses. 

5451.  Statistical Quality Control (101)  crn: 31653
8:30 am - 3:00 pm Sundays (1/2 hour lunch):  Jan 21, Feb 4, 18, Mar 4, 18, Apr 8.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 22 or May 6.
In-class, proctored exam:  Mar 4.
Faculty:  R. Snee
Required text:  Introduction to Statistical Quality Control, Montgomery, 7th ed, (ISBN-13: 978-1118146811).
Not open to students who have taken Pharmaceutics 451.

5459. Drug Development (101) crn:   36987
6:00 pm - 9:30 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 3 or 10.
In-class, proctored exam:  Feb 20.
Faculty:  P. Sax
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 (102) crn: 7315
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Jan 27, Feb 10, 24, Mar 10, 24, Apr 14.  Meets 6 times plus final exam.
Make-up, if needed, Apr 28 or May 5.
In-class, proctored exam:  Mar 10.
Faculty:  C. Wittrock
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.

5472.  Pharmaceutical Marketing (101)  crn:  28681
8:30 am - 3:00 pm Sundays (1/2 hour lunch):  Jan 28, Feb 11, 25, Mar 11, 25, Apr 13.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 29 and May 6.
In-class, proctored exam:  Mar 11
Faculty:  D. Hisey
Required text: Pharmaceutical Marketing, 8th ed, Rollins and Perri, (ISBN-13: 978-1-449697990 or ISBN-10:1449697992).
Not open to students who have taken Pharmaceutics 480.

5477. Good Manufacturing Practices (101)  crn:  25825
9:00 am - 3:30 pm Sundays (1/2 hour lunch):  Jan 21, Feb 4, 18, Mar 4, 18, Apr 8 (mandatory field trip).  Meets 6 times plus final exam.  Make-ups, if needed, Apr 22 and May 6.
Note:  this class includes a required field trip on Apr 8.
In-class, proctored exam:  Mar 4.
Faculty:  T. Ely
No required text.
Not open to students who have completed Pharmaceutics 487.

5491.  Pre-Approval Inspections (101) crn:  31570
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.
In-class, proctored exam:  Feb 28.
Faculty:  K. Campbell and D. Pagano
No required text.
Not open to students who have taken Pharmaceutics 490.

5495.  IND/NDA Submissions (101)  crn:  28682
8:30 am - 3:00 pm Saturdays (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 and May 5.
In-class, proctored exam:  Mar 3.
Faculty:  P. Smith
Required text:  New Drug Development:  A Regulatory Overview, Mathieu, 8th ed, (ISBN:  1-882615--85-9).
Not open to students who have completed Pharmaceutics 495.

5508.  Good Pharmacovigilance Operations (101)  crn:   36988
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.
Note: 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.

5536.  Good Clinical Practices (101)  crn:  36989
6:00 pm - 9:30 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29.  Meets 10 times plus final exam.  Make-ups, if needed, Apr 5 or 12.
In-class, proctored exam:  Feb 22.
Faculty:  P. Sax
No required text.  Students may purchase 2016 CFR/ICH GCP Reference Guide.  Order from www.barnettinternational.com.  Or, they may also obtain the same regulations through Internet sources.
Not open to students who have taken Pharmaceutics 536.

5537. Clinical Trial Management (101) crn: 31583
8:30 am - 5:00 pm Sundays (1 hour lunch):  Jan 21, Feb 4, 18, Mar 4, 18. Meets 5 times plus final exam. Make-ups, if needed, Apr 8 or Apr 22.
In-class, proctored exams: Feb 18 and Mar 18.
Faculty:  L. Edwards
Required text:  Principles and Practices of Pharmaceutical Medicine, 3rd ed, (ISBN: 978-1-4051-9472-3).
Available on the Paley Library website for registered students: http://vv4kg5gr5v.search.serialssolutions.com/?V=1.0&L=VV4KG5GR5V&S=JCs&C=TC0000441153&T=marc
Not open to students who have taken Pharmaceutics 537.

5538.  Clinical Drug Safety and Pharmacovigilance (101)  crn:   31577
Prerequisite:  Good Clinical Practices (5536).
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Jan 27, Feb 10, 24, Mar 10, 24, Apr 14.  Meets 6 times plus final exam.
Make-up, if needed, Apr 28 or May 5.
In-class, proctored exam:  Mar 10.
Faculty:  B. Appleton
Required text: Pharmacovigilance Medical Writing:  A Good Practice Guide, Orleans-Lindsay, ISBN:  978-1-119-96726-2).
Not open to students who have taken Pharmaceutics 538 or 5571.

5548.  Risk Management of Pharmaceutical and Medical Devices (101)  crn: 31582
8:30 am - 3:30 pm Sundays (1 hour lunch):  Jan 21, Feb 4, 18, Mar 4, 18, Apr 8.  Meets 6 times including final presentations.  Make-ups, if needed, Apr 22.
In-class, proctored exam:  Mar 4.
Faculty:  T. Genova
No required text.

5571.  Post-Marketing Safety Surveillance  (101)  crn:   28684
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, 538 or 5538.  Students may take Pharmaceutics 5571 or 5538, but not both courses.

5572.  Vaccines:  RA and QA Issues (101) crn: 28685
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.

5575.  Regulatory Sciences:  Managing the Guidelines for Quality (101)  crn: 36990
Prerequisite:  strong science background required.  Forward resume to RAQA Office for approval.
8:30 am - 4:30 pm Saturdays (1/2  hour lunch):  Jan 27, Feb 10, 24, Mar 10, 24.  Meets 5 times plus final exam.  Make-ups, if needed, Apr 14 or 28.
In-class, proctored exam:  Feb 24.
Faculty:  T. Schultz
No required text.
Not open to students who have completed Pharmaceutics 580.

5591.  Global Regulatory Affairs (101)  crn:  31579
Prerequisite:  Drug Development (5459) or Food and Drug Law (5592).
8:30 am - 3:00 pm Sundays (1/2 hour lunch):  Jan 28, Feb 11, 25, Mar 11, 25, Apr 13.  Meets 6 times plus final exam.  Make-ups, if needed, Apr 29 or May 6.  (Tentative Schedule)
In-class, proctored exam:  Mar 11.
Faculty:  R. Alliegro
No required text.
Not open to students who completed Pharmaceutics 591.

5592.  Food and Drug Law (101) crn:  2190
8:30 am - 3:00 pm Saturdays (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 May 5.
In-class, proctored exam:  Mar 3.
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.

5592.  Food and Drug Law (102) crn: 20660
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.
In-class, 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.

5612.  Bioethics for Pharmaceutical Professionals (101)  crn:   31569
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.
Note: 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.

5650.  Current Topics: Current Global Regulatory Issues (101) crn:   28697
8:30 am - 3:00 pm Saturdays (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 May 5.
In-class, proctored exam:  Mar 3.
Faculty:  P. Moriati
No required text.

5650 Current Topics:  Current Global Regulatory Issues (102) crn:  37007
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.
In-class, 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.

PHARMACEUTICAL SCIENCE COURSE
8005.  Pharmaceutical Biotechnology (101)  crn:  20673
Prerequisite:  strong science background, including 2 years of general chemistry, including organic and analytical.
8:30 am - 3:00 pm Saturdays (1/2 hour lunch):  Jan 20, Feb 3, 17, Mar 3, 17, Apr 7, 21 (proctored final).  Meets 6 times plus final exam.  Make-up, if needed, May 5.
In-class, proctored exams:  Mar 3 and April 21.
Faculty:  T. 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, (ISBN 0-470-84327-6).  Available online.  Students should have access to textbooks in biochemistry and/or molecular biology from previous courses.

PHARMACEUTICAL SCIENCE COURSE
8006.  Physical Pharmacy (101)  crn: 37005
Prerequisite:  strong science background, including 2 years of general chemistry, including organic and analytical.
6:00 pm - 9:30 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 15, 22 (tentative), 29 (tentative), Apr 5, 12, 19 (in-class, proctored final).  Meets 10 times plus final exam.  No class Mar 8. and possibly on Mar 22 or 29 (to be announced).  Make-ups, if needed, Apr 26 or May 3.
In-class, proctored exam:  Apr 19.
Faculty:  D. Lebo
Required text: Martin’s Physical Pharmacy and Pharmaceutical Sciences, J. Sinko, Lippincott Williams & Wilkins, 6th ed, (ISBN:  9780781850271).
Not open to students who have taken Pharmaceutics 485.

PHARMACEUTICAL SCIENCE COURSE
8007.  Applied Biopharmaceutics (101) crn: 7327
Prerequisite:  strong science background, including 2 years of general chemistry, including organic and analytical.
5:30 pm - 8:30 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 13, 20, 27, Apr 3, 10, 17, 24 (in-class, proctored final).  Meets 12 times plus final exam.  Make-up, if needed, May 1. No class Mar 6.
In-class, proctored exam:  Apr 24.
Faculty:  R. Fassihi
No required text.
Not open to students who have taken Pharmaceutics 410.

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Registration Form for Traditional Courses at Fort Washington

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

How to Register

Is this your first QARA 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 RA and QA? 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
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
 Or, phone: 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.

This schedule is subject to change.

Temple University RA and QA homepage

 
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance (RA and QA) Graduate Program

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

 

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