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

 

Weekend Courses - Spring 2018 - Traditional Classroom Format Only

Saturday Courses Starting January 20

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.

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.

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.

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.

8005.  Pharmaceutical Biotechnology (101)  crn:  20673
Prerequisite:  strong science background, including 2 years of general chemistry, including organic and analytical chemistry.  Include resume with registration form.
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.

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Saturday Courses Starting January 27

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.

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.

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.

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Sunday Courses Starting January 21

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.

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.

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.

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.

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Sunday Courses Starting January 28

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.

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.

This schedule is subject to change.

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