Course Materials

If your course is not listed here, no materials are required other than those provided within the course.

RA 602 – Food and Drug Law

Textbook: A Practical Guide to Food and Drug Law and Regulation, 7th edition
Author(s): Pines, W.L. and Kanovsky, S.M.
Publisher: Washington, D.C.: Food and Drug Law Institute, 2020
ISBN: 978-1-935065-87-6
Ordering Information: This textbook is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the SDSU Global Campus session in which you are registered, “Regulatory Affairs”, then “RA 602” and your instructor’s session.

RA 605 – Medical/Scientific Writing for Life Science Professionals

Handbook: Medical/Scientific Writing for Healthcare Professionals
Author(s): Bekins, Linn
Ordering Information: This handbook is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the SDSU Global Campus session in which you are registered, “Regulatory Affairs” and then “RA 605.”

RA 696 – Lean Six Sigma for Quality Sciences

Textbook: The Certified Six Sigma Green Belt Handbook, Second Edition
Author(s): Munro R., Ramu G., & Zyrmiak D.
Publisher: American Society for Quality (March 3, 2015)
ISBN: 978-0873898911
Ordering Information: This textbook is available from the SDSU Bookstore. Click “Global Campus (Credit) Accept” to proceed with your order.

RA 703 – Introduction to Electronic Submissions

Software: docuBridge ONE
Developer: LORENZ
Ordering Information: This software is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the SDSU Global Campus session in which you are registered, “Regulatory Affairs” and then “RA 696.” NOTE: This software package will become available for purchase on the first day of the course.

More information about docuBridge ONE can be found at http://www.lorenz.cc/eSolutions/docuBridge-one/ Technical specifications and an introductory video are also available on this page. (Note that this software is not compatible with Mac OS and must be run on a PC, or on a Mac with VMware using a supported Windows OS.) The discounted cost of the software for students enrolled in this course is $315. At the end of the course, students may keep the software; however they will no longer be able to generate eCTD submissions. Students will be credited with one free publishing token if they purchase a full software license within 90 days of the course conclusion.

Software: Adobe Acrobat Pro
Developer: Adobe
Ordering Information: For $25, students may access Adobe Creative Cloud, which includes Adobe Acrobat Pro, via SDSU’s partner for software distribution, Kivuto Web Store “OnTheHub“. The steps are listed below:

1. Go to https://onthehub.sdsu.edu to be routed to the Kivuto Web Store “On the Hub”.
2. Sign in with your SDSUid.
3. Select Adobe Creative Cloud and Add to Cart.
4. Purchase Adobe Creative Cloud.
5. Sign into Adobe Creative Cloud applications with your SDSUid

* Note that this license is good for 1 year and will need to be renewed annually.

RA 705 – Project Planning for the Biomedical Industries

Textbook: The Project Management Memory Jogger, 2nd Edition
Author(s): Martin, P. and Tate, K.
Publisher: Salem, NH.: GOAL/QPC, 2010
ISBN: 978-1576811221
Ordering Information: This book may be purchased from Amazon.

Software: MS Project
Ordering Information: Students are responsible for obtaining Microsoft Project for this course. While the course tutorials are based on Microsoft Project 2016 and this is the recommended version, other versions of the software may be used.

One alternative is to subscribe to Project Online Professional directly from Microsoft at https://products.office.com/en-us/project/compare-microsoft–project-management-software?tab=1. This option is $30/mo, and requires a minimum one-year commitment. Note that any students with Microsoft 365 installed on their computers MUST use Project Online Professional, since both products must reside in the cloud for Project to work correctly. Another alternative is to obtain Microsoft 2016 from a vendor online.

Note: MS Project requires a PC running MS Windows. While it is possible to run MS Project on a Mac running Parallels (or other Windows virtualization software), no technical support is provided by SDSU for this option. Please visit the Microsoft website for a complete list of system requirements under “Office standalone applications”.

Software: Parallels Desktop for Mac (Optional, for students running Project on a Mac platform. Note that no technical support is provided by SDSU for this option.)
Ordering Information: This software is available from the SDSU Bookstore.

RA 750 – Leadership for Change and Continuous Improvement

Textbook: The Team Handbook, 3rd Edition
Author(s): Scholtes, P., Joiner, B., and Streibel, B.
Publisher: Madison, WI: Oriel, Inc., 2003
ISBN: 978-1884731266
Ordering Information: This book may be purchased from Amazon.

RA 761 – Drug/Device Product Development and Regulation in Europe and the US

*Note that the following text is optional.

Textbook: Fundamentals of International Regulatory Affairs, 5th Edition
Publisher: Regulatory Affairs Professionals Society, 2021
ISBN: 978-1-947493-63-6
Ordering Information: This book (hard cover or e-book) may be purchased from RAPS at a student rate. Contact Ana Righellis at righellis@sdsu.edu for the discount code.

RA 774 – Investigational and Marketing Applications for Drugs and Biologics

Textbook: Fundamentals of US Regulatory Affairs, 11th Edition
Publisher: RAPS, 2019
ISBN: 978-1-947493-33-9
Ordering Information: Hardcover and eBook editions may be purchased from RAPS at a student rate. Contact Ana Righellis at righellis@sdsu.edu for the discount code.

RA 781 – Ethics for Life Science Professionals

Textbook: Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary
Author(s): Emanuel, E., et al.
Publisher: Baltimore, MD: The Johns Hopkins University Press, 2003
Ordering Information: This textbook is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the SDSU Global Campus session in which you are registered, “Regulatory Affairs”, then “RA 781” and your instructor’s session.

Textbook: The Immortal Life of Henrietta Lacks
Author: Skloot, Rebecca
Publisher: Broadway Books, 2011
ISBN-10: 1400052181
Ordering Information: This book may be purchased from Amazon.

RA 783 – Effective Communication for Regulatory Science

Textbook: Writing and Speaking at Work: A Practical Guide for Business Communication, 5th edition
Author: Bailey, Edward P.
Publisher: Prentice Hall, 2010
ISBN: 978-0136088554
Ordering Information: This textbook is available from the SDSU Bookstore. Accept the Global Campus (Credit) agreement, then log in with your SDSUid to make your purchase. If you have any issues with placing your order, email Laura White at laura.white@sdsu.edu for assistance.