Fall 2024 Schedule for the RAQA Graduate Program (Updated: September 11, 2024)
All courses are listed in numerical order in East Coast Time (remember to adjust class start times to your time zone)
Registration Form for Online Courses
Expectations of Online Students
All RAQA online courses use Zoom, which is provided for free to all registered Temple students.
Required hardware
RAQA online courses are interactive. Your computer or laptop must have a webcam and microphone. Many laptops have built-in webcams and speakers. If your laptop does not, you will be required to purchase them.
If you are a new student or are using Zoom for the first time, watch the online course tutorial. A password is given at the end which you must include on the registration form.
After watching the tutorial, schedule an online meeting with David Brickett ([click-for-email]) or Mike Doukas ([click-for-email]) to review how Zoom works, so you'll be ready for your first online class meeting.
RPNow is an online proctoring service, which enables you to take exams at almost any location. RPNow charges $15.00 per exam, which you must pay with a credit card when the exam starts. (You must also pay that fee if you use RPNow in a Temple computer lab.) If a course uses RPNow, all students in the class must use that service.
RPNow exams require a laptop or computer. Chrome notebooks, iPads, cell phones and other devices will not work. You must also have administrative access to your laptop or computer, which means you can install software. (Many office computers have built-in firewalls that will not allow software downloads.) Please check this before registering.
Use Chrome or Firefox for your Browser.
Check class dates carefully. You are expected to take proctored exams on the scheduled date. If you do not, you will be charged $25.00 for an initial makeup exam; $50 for the second missed exam, and $100 per exam thereafter. For more on this policy, click here.
NEW COURSES THIS FALL (courses are listed numerically, so scroll down to learn their dates, times, and instructors:
5504. Patient Focused Regulatory Policy for Medical Products (990) (ONLINE)
5534. Regulatory Aspects of Biomedical/Technical Communication (990)
5543. Good Distribution Practices (990)
5650. Pharmaceutical Regulatory Leadership (On-Campus Course at RAQA's Fort Washington Location)
FULL SCHEDULE OF FALL CLASSES
5000. KENX Conferences 1.5 credit hours each section Expectations of Online Students Registration Form for Online Courses
Did you know that you can earn 1.5 credits towards the MS in RAQA by attending specific KENX conferences in Chicago (IL), RTP (NC) or Washington DC this fall? Each conference meets over 2.5 days. You attend sessions marked “Temple Track,” then take a proctored open-book final exam within 6 weeks. For more detailed information on conference topics and locations, visit kenx.org/conferences. All KENX Conference courses require a $15.00 RPNow Online Proctoring fee for each conference.
Topics for Fall 2024 include:
- Oct 22-24, 2024: GMP U, RTP, NC (in-person only), section 008 crn: 54373
- Dec 10-12, 2024, CSV and CSA, Washington, DC, (in-person only), section 009, crn: 54387.
ON-CAMPUS COURSE at Ft Washington:
5459. Drug Development (101) crn: 49409 (ON-CAMPUS COURSE) See On-Campus Schedule for Details.
2:00 pm – 5:30 pm Wednesdays: Sept 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20. Meets 10 times plus final exam. Makeup, if needed, Dec 4 and 11.
In-class, proctored exam: Oct 16.
5459. Drug Development (990) crn: 17910 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: C. Ciliberto
Required text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272).
Not open to students who have completed RAQA 459 or P381.
5459. Drug Development (991) crn: 7407 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: J. Hayes
Required text: Drugs, From Discovery to Approval, third edition, Rick, Ng, ISBN-13:978-1118907276 or ISBN-10: 1118907272.
In addition, students will be required to choose one of the following texts and write a book review:
1) The Poison Squad: One Chemist's Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, Paperback – Illustrated, Sep 2019, Deborah Blum OR
2) The Jungle, Paperback, 2019, Upton Sinclair
3) The Great Influenza: The Story of the Deadliest Pandemic in History, Paperback – Oct 2005, John M. Barry
4) The Antidote: Inside the World of New Pharma, Barry Werth.
Not open to students who have completed RAQA 459 or P381..
WEEKEND COURSE
5459. Drug Development (992) crn: 28608 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
8:30 am – 2:00 pm Saturdays: Sept 14, 28, Oct 12 (Columbus Day weekend), 26, Nov 9, 23, Dec 7. Meets 7 times plus final exam. Make-up, if needed, Dec 14.
Proctored exam: Oct 26 (RPNow)
Faculty: P. Smith
Required text: Drugs: From Discovery to Approval, third edition, Rick, Ng, , ISBN-13:978-1118907276 or ISBN-10: 1118907272
Not open to students who have completed RAQA 459 or P381..
5474. Process Validation (990) crn: 54364 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisites: BS in Pharmacy, Chemistry, Biology or Engineering and strong science background, including familiarity with chemistry, biology, and physics. Students should also have a basic understanding of pharmaceutical manufacturing processes.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 17 (RPNow)
Faculty: K. Barnthouse
Required texts: 1) Process Validation in Manufacturing of Biopharmaceutics, 3rd edition, Anurag S. Rathore and Gail Softer, editors, CRC Press 2012, AND 2) How to Validate a Pharmaceutical Process, 1st edition, Steven Ostrove, Eisevier, 2016.
Not open to students who completed RAQA 484 or Pharmaceutics 8484.
5477. Good Manufacturing Practices (990) crn: 9357 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:30 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, Nov 4, 11 (Veterans' Day), 18, 25. Meets 10 times plus final exam. No class Oct 28th. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Nov 25 (RPNow)
Faculty: M. Noonan
No required text.
Not open to students who have completed RAQA 487.
5477. Good Manufacturing Practices (991) crn: 34740 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: K. Zimm
No required text.
Not open to students who have completed RAQA 479.
5494. Quality Audit (990) crn: 25897 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: a good practices course: GL
s (5476), GMPs (5477), Advanced GMPs (5479), or GCPs (5536).
7:00 pm - 10:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26, Dec 3. Meets 12 times plus final exam. Make-ups, if needed, Dec 10 and 17.
Proctored exam: Dec 3 (RPNow)
Faculty: J. Werrmann
Required text: The ASQ Certified Quality Auditor, 5th edition, Lance B Coleman Sr. Available from ASQ Quality Audit Press: www.asq.org/quality-press, ISBN 978-1-951058-09-8, copyright 2020. (Previous editions released as The ASQ Audit Handbook). Note: purchase a hard copy of the 5th edition. Do not buy earlier editions or eBooks.
Not open to students who have completed RAQA 494.
5495. IND/NDA Submissions (990) crn: 46250 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12. Meets 12 times plus final exam. No class on Sept 26 and Nov 28 (Thanksgiving). Make-up date, if needed, Dec 19.
Proctored exam: Oct 24 (RPNow)
Faculty: A. Smith
Required text: New Drug Development: A Regulatory Overview, Mathieu, 8th revised edition.
Not open to students who have completed RAQA 495.
5496. Regulation of Medical Devices Compliance (990) crn: 51969 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-up, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: M. Arentz
No required text.
Not open to students who have completed RAQA 496.
5504. Patient-Focused Regulatory Policy for Medical Products (990) crn: (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisites: Drug Development (5459) and Food and Drug Law (5592).
Suggested prerequisites: Regulation of Medical Devices Submissions (5502), IND/NDA Submissions (5495).
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12. Meets 12 times plus final exam. No class Nov 28 (Thanksgiving). Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: C. Kuehn
Required text: all readings will be posted in Canvas.
Description: This course provides an overview of patient-focused regulatory policy impacting the global regulation of medicines and medical devices. It covers the legislative and regulatory history of U.S FDA patient-focused policy, such as Patient Preference Information and Patient Focused Drug Development. It surveys similar policy efforts in Canada, Australia, the E.U. and other areas. Discussions include evidence for the value of patient engagement in product development, examples of medical products cleared or approved using patient input, and expectations by regulators for the use of patient-generated data to support regulatory submissions. The value of including the patient voice in regulatory decision-making, the impact of patient-focused policy on regulatory decisions, and current policy issues, challenges, and opportunities will also be discussed.
5508. Good Pharmacovigilance Operations (990) crn: 51972 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Mondays: Sept 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans' Day), 18, 25, Dec 2, 9. Meets 12 times plus final exam. Make-up, if needed, Dec 16.
Proctored exam: Dec 9 (RPNow)
Faculty: L. Thomas
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.
5515. Biologics/Biosimilars: A Regulatory Overview (990) crn: 28574 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisites: Drug Development (5459). Science background required (students should include resume.)
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2, 9, 16, 23, 30 (recording), Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: F. Diana
No required text.
5533. Requirements for Product Labeling and Advertising (990) crn: 51974 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Food and Drug Law (5592).
6:00 pm – 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26, Dec 3. Meets 12 times plus final exam. Make-ups, if needed, Dec 10 and 17.
Proctored exam date: Dec 3 (RPNow)
Faculty: D. Cooke and S. Desai
No required text.
Not open to students who have completed RAQA 533.
5534. Regulatory Aspects of Biomedical/Technical Communication (990) crn: 56688 Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592) or permission of the instructor.
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: R. Arbaugh
Required text: Regulatory Writing: An Overview, Second Edition, L. DeTora, Published by RAPS, 2020. ISBN: 978-1-947493-55-1. Readings also posted on Canvas.
Not open to students who have completed RAQA 534.
5536. Good Clinical Practices (990) crn: 9358 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, Dec 3. Meets 12 times plus final exam. No class Nov 26. Make-ups, if needed, Dec 10 and 17.
Proctored exam: Oct 22 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 536.
WEEKEND COURSE
5536. Good Clinical Practices (991) crn: 56678 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
10:00 am – 1:00 pm Saturdays: Sept 7, 14, 21, 28, Oct 5, 12 (Yom Kippur), 19, 26, Nov 2, 9, 16, 23. Meets 12 times plus final exam. Make-ups, if needed, Dec 7 and 14.
Proctored exam: Oct 19 (RPNow)
Faculty: D. Walsh
Required texts: All references and readings are available online.
Not open to students who have completed RAQA 536.
5537. Clinical Trial Management (990) crn: 49401 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Good Clinical Practices (5536). Students with clinical experience may ask to take the course but must include their resume with registration.
6:00 pm - 9:00 pm Wednesdays: Sept 18, 25, Oct 2, 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27 (review recordings). Make-up, if needed, Dec 11 and 18.
Proctored exam: Oct 23 (RPNow)
Faculty: J. Scavone
No required text.
Not open to students who have completed RAQA 537.
5538. Clinical Drug Safety and Pharmacovigilance (990) crn: 56672 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Good Clinical Practices (5536 or P383) or appropriate experience in industry GCPs (send resume with registration form).
7:00 pm – 10:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: J. Robinson
No required text.
5543. Good Distribution Practices (GDPs) (990) crn: 56677 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Good Manufacturing Practices (5477)or Advanced GMPs (5479).
6:00 pm - 9:00 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans' Day), 18, 25. Meets 12 times plus final exam. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Oct 21 (RPNow)
Faculty: J. Hayes
Required text: Protecting Patients at All Costs: The Drug Watch Dogs, Vantrieste, 2024.
Students will also select one of the following and present a summary in class:
Making a Killing:The Deadly Implications of the Counterfeit Drug Trade, R. Bate. OR
China Rx: Exposing the Risks of America’s Dependence on China for Medicine; Gibson; ISBN-10: 1633886417 OR
Protecting America’s Health: FDA, Business, & One Hundred Years of Regulation; Hilts; ISBN-10: 0807855820.
5545. Post Approval Changes (PAC) (990) crn: 56689 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459). .
6:00 pm – 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, Dec 3. Meets 12 times plus final exam. No class Nov 26. Make-ups, if needed, Dec 10 and 17.
Proctored exam: Oct 22 (RPNow)
Faculty: K. Zimm
No required text.
5546. Global Excipient Regulation (990) crn: 46254 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm – 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 9, 16, 23 (recording), 30, Nov 6, 13, 20, Dec 4, 11. Meets 12 times plus final exam. No class Oct 2 and Nov 27. Make-up, if needed, Dec 18.
Proctored exam: Oct 30 (RPNow)
Faculty: D. Schoneker
No required text
Not open to students who have completed RAQA 546.
5548. Risk Management for Pharmaceutical and Medical Devices (990) crn: 42737 (ONLINE) CLOSED Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans' Day),18, 25. Meets 12 times plus final exam. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Oct 21 (RPNow)
Faculty: T. Genova
No required text
5572. Vaccines: RA and QA Issues (990) crn: 39783 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
This course has limited seats. If you wish to enroll, send in your registration form right away.
Prerequisite: Drug Development (5459). Students are also expected to have a college-level background in general biology and chemistry and some knowledge of general microbiology and/or immunology.
6:00 pm - 9:00 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (recording), 18, 25. Meets 12 times plus final exam. Make-ups, if needed, Dec 2 and 9.
Proctored exam: Oct 14 (RPNow)
Faculty: K. Surowitz
Required texts: Do not purchase texts until AFTER hearing discussion in the first class.
(1) Autism’s False Prophets, Paul Offit, 2008, Columbia University Press. Available in the Temple U Charles Library online.
(2) Epidemiology and Prevention of Vaccine Preventable Diseases, 13th edition, U.S. Centers for Disease Control (CDC). Students may download individual chapters for free or purchase the paperback from the CDC.
(3) The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and other Biologics, John Geigert,3rd edition, 2019, Springer. Available in the Temple U Charles Library online.
(4) Plotkin’s Vaccines, 7th edition, 2018, Plotkin, Orenstein, Offit, Edwards, editors, Elsevior. Available in the Temple U Charles Library online.
Not open to students who have completed RAQA 572.
5574. Quality Management Systems (990) crn: 46256 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisites: Drug Development (5459)
6:00 pm - 9:30 pm Mondays: Sept 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28 (recording), Nov 4, 11 (Veterans' Day), 18. Meets 10 times plus final exam. Make-ups, if needed, Nov 25 and Dec 2.
Proctored exam: Oct 21 (RPNow).
Faculty: M. LaBruto
No required text.
5577. Global CMCs – Biopharmaceuticals and Other Biologics (990) crn: 28578 (ONLINE) CLOSED Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26. Meets 12 times plus final exam. Make-ups, if needed, Dec 3 and 10.
Proctored exam: Oct 15 (RPNow)
Faculty: J. Quinn
Required text: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics, John Geigert, 3rd edition, 2019, Science & Media, NY, ISBN-13: 978-3030137533).
5579. Regulatory and Legal Basis of Pharmacovigilance (990) crn: 56674 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Clinical Drug Safety and Pharmacovigilance (5538) or Post Marketing Safety Surveillance (5571) or permission of RAQA Office (forward resume).
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4, 11. Meets 12 times plus final exam. No class Nov 27. Make-up, if needed, Dec 18.
Proctored exam: Dec 11 (RPNow)
Faculty: K. Ward
Required text: Colbert’s Manual of Drug Safety and Pharmacovigilance, Colbert, Gregory & Thomas, 3rd edition, World Scientific, ISBN: 9813278846 or 9789813278833.
5591. Global Regulatory Affairs (990) crn: 23442 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Drug Development (5459) or Food and Drug Law (5592).
6:00 pm – 9:00 pm Wednesday: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam: Oct 16 (RPNow)
Faculty: R. Phillips
No required text.
Not open to students who have completed RAQA 591.
5592. Food and Drug Law (990) crn: 7202 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Wednesdays: Sept 11, 18, 25, Oct 2 (Rosh Hashanah), 9, 16, 23, 30, Nov 6, 13, 20, Dec 4. Meets 12 times plus final exam. No class Nov 27. Make-ups, if needed, Dec 11 and 18.
Proctored exam date: Oct 23 (RPNow)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5th edition. Do not buy earlier editions or eBooks.
West Academic Publishing gives a 15% discount and free ground shipping to students for these texts. You must create an account, use promo code HESTUDENT, and place your order directly through www.westacademic.com.
Not open to students who have completed RAQA 592.
5592. Food and Drug Law (991) crn: 23754 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, Dec 3. Meets 12 times plus final exam. No class Nov 26. Make-ups, if needed, Dec 10 and 17.
Proctored exam date: Oct 22 (RPNow)
Faculty: G. Pilgrim
Required text: Food and Drug Law: Cases and Materials, 5th edition, hard copy only, Hutt, et al, West Academic Publishing. Purchase the hard copy of the 5th edition. Do not buy earlier editions or eBooks.
West Academic Publishing gives a 15% discount and free ground shipping to students for these texts. You must create an account, use promo code HESTUDENT, and place your order directly through www.westacademic.com .
Not open to students who have completed RAQA 592.
5595. Food Law (990) crn: 54379 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm – 9:30 pm Thursdays: Sept 12, 19, 26, Oct 10, 17, 24, Nov 7, 14, 21, Dec 5, 12. Meets 10 times plus final exam. No class Oct 3 (Rosh Hashanah), Oct 31, or Nov 28 (Thanksgiving). Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: M. Noonan
No required text.
5612. Bioethics for Pharmaceutical Professionals (990) crn: 42739 (ONLINE)
Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-ups, if needed, Dec 12 and 19.
Proctored exam: Oct 24 (RPNow)
Faculty: D. Walsh
Required text: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, Emanuel, Crouch, Arras, Moreno and Grady, Johns Hopkins University Press, 2003.
Not open to students who completed RAQA 512.
AFTERNOON ON-CAMPUS COURSE at Fort Washington
5650. Pharmaceutical Regulatory Leadership (101) crn: 56676 (ON-CAMPUS COURSE) Registration Form for On-Campus Courses at Fort Washington
Suggested prerequisite: Drug Development (5459) OR Food and Drug Law (5592).
2:00 pm – 5:30 pm Tuesdays: Sept 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19. Make-ups, if needed, Nov 26 and Dec 3.
In-class, proctored exam: Oct 15.Faculty: P. Sax
Suggested texts: The Practice of Management, P. Drucker; The Definitive Drucker, E.H Edersheim, Who Moved My Cheese, S Johnson.
Description: Leadership in the pharmaceutical industry requires more than regulatory knowledge: it requires key skills to get the job done with various constituents, including coworkers, employees, and management. This course provides insights, rules, tools and requirements needed to lead in the highly regulated pharmaceutical industry. Students will study organizational principles and practices within the framework of the Code of Federal Regulations (specifically 21 CFR 210, 211, 312, 600 and 820).
PHARMACEUTICAL SCIENCE COURSES: All courses listed below required a strong background in science, including a bachelor's degree in a science-related field or engineering.
PHARMACEUTICAL SCIENCE COURSES
5492. Production of Sterile Products (990) crn: 56673 (ONLINE) Expectations of Online Students Registration Form for Online Courses
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: strong science background. Submit resume with registration.
6:00 pm - 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17, 24, 31, Nov 7, 14, 21, Dec 5, 12. No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exam: Dec 12 (RPNow)
Faculty: D. Casaburi
Required text: Aseptic and Sterile Processing Compliance and Future Trends, Sandle and Tidswell, Parenteral Drug Association, 2017, ISBN 9781942911128. Available in hardcover or digital.
Not open to students who have completed RAQA 492.
PHARMACEUTICAL SCIENCE COURSE
8002. Pharmaceutical Analysis (990) crn: 46377 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Prerequisite: strong science background. This consists of a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for permission to register.
5:30 pm - 8:30 pm Mondays: Sept 9, 16, 23, 30, Oct 7, 14 (Columbus Day), 21, 28, Nov 4, 11 (Veterans’ Day), 18, Dec 2, 9. Meets 12 times plus final exam. No class Nov 25. Make-up, if needed, Dec 16.
Proctored exams: Oct 21 and Dec 9 (via Zoom)
Faculty: D. Canney, A. Fermier, S. Mehrman
No required text.
Not open to students who have completed Pharmaceutics 411.
PHARMACEUTICAL SCIENCE COURSE 8003. Preformulation - Small Molecules (990) crn: 54371 (ONLINE) Expectations of Online Students Registration Form for Online Courses
(Formerly Pharmaceutical Manufacturing I: Preformulation/Formulation)
This course uses RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to RPNow via credit card at the start of the proctored exam.
Prerequisite: Strong science background required. RAQA students must submit their resume for permission to register.
5:30 pm - 8:30 pm Tuesdays: Sept 10, 17, 24, Oct 1, 8, 15, 22, 29, Nov 5, 12, 19, 26. Meets 12 times plus final exam. Make-ups, if needed, Dec 3 and 10.
Proctored exam: Oct 22 (RPNow)
Faculty: T. Schultz
Required text: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, Taylor & Aulton, 4th edition, 2013, Churchill Livingstone, (ISBN: 9780702042904 or 9780702053931). Pharmaceutics 406.
PHARMACEUTICAL SCIENCE COURSE 8005. Pharmaceutical Biotechnology (990) crn: 54372 (ONLINE) Expectations of Online Students Registration Form for Online Courses
Strong science background required, including a minimum of 2 years of general chemistry, including one organic and one analytical chemistry course. RAQA students must submit their resume for permission to register.
6:00 pm – 9:00 pm Thursdays: Sept 12, 19, 26, Oct 3 (Rosh Hashanah), 10, 17 (proctored midterm), 24, 31, Nov 7, 14, 21, Dec 5, 12 (final). No class Nov 28 (Thanksgiving). Meets 12 times plus final exam. Make-up, if needed, Dec 19.
Proctored exams: Oct 17 and Dec 12 (proctored through Zoom)
Faculty: T. Parry
Required text: Pharmaceutical Biotechnology: Fundamentals and Applications, Crommelin, Sindelar & Meibohm, editors, any of the 3rd through 6th editions should be ordered, Informa Healthcare 2007 (ISBN 10: 1420044370), ISBN 13 978 1420044379). Paperback recommended. Suggested: Biopharmaceutical: Biochemistry and Biotechnology, Walsh, G., 2nd edition, (ISBN 0 470 84327 6), available online. Students should have access to textbooks in biochemistry and/or molecular biology.
Not open to students who have completed Pharmaceutics 475.
Expectations of Online Students
Registration Form for Online Courses