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, 6th edition
Author(s): Pina, K.R. and Pines, W.L.
Publisher: Washington, D.C.: Food and Drug Law Institute, 2017
ISBN: 978-1935065845
Ordering Information: This textbook is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the Extended Studies 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 Extended Studies session in which you are registered, “Regulatory Affairs” and then “RA 605.”

RA 696 – Introduction to Electronic Submissions

NOTE: These software packages will become available for purchase on the first day of the course.

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 Extended Studies session in which you are registered, “Regulatory Affairs” and then “RA 696.”

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 $300. At the end of the course, students may keep the software; however they will no longer be able to generate eCTDs. 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: This software is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the Extended Studies session in which you are registered, “Regulatory Affairs” and then “RA 696.”

RA 696 – Regulatory Intelligence/Regulatory Strategy

Textbook: Regulatory Intelligence 101
Publisher: Regulatory Affairs Professionals Society (RAPS)
Ordering Information: This book may be ordered directly from RAPS. Students can purchase this book online at the student rate of $37.48 (US) plus shipping by using the discount code ‘RAPSEDU‘.

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 Standard 2016
Ordering Information: This software is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the Extended Studies session in which you are registered, “Regulatory Affairs” and then “RA 705.” If the Summer session is not yet listed, please check the Spring session.
Note that MS Project 2016 requires a PC running MS Windows, or a Mac running Parallels (or other Windows virtualization software). Please visit the Microsoft website for a complete list of system requirements.

Software: Parallels Desktop for Mac (Optional, for students running MS Project Standard 2016 on Mac platform. Note that no technical support is provided by SDSU for this option.)
Ordering Information: This software is available from the SDSU Bookstore. After you accept the “Ship-To-Home Textbook Agreement”, select the Extended Studies session in which you are registered, “Regulatory Affairs” and then “RA 705.” If the Summer session is not yet listed, please check the Spring session.

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 774 – Investigational and Marketing Applications for Drugs and Biologics

Textbook: Medical Device Development: Regulation and Law
Author(s): Kahan, J. S.
Publisher: Parexel, 2014

Textbook: New Drug Development: A Regulatory Overview, 8th Edition
Author(s): Mathieu, M.
Publisher: Parexel, 2008

Ordering Information: Note that you can obtain a student discount on these books by placing your order with a representative at 800-856-2556 from 8:30am -5:00pm EST and giving your university and class information. Overnight shipping is available; regular shipping is 7-10 business days.

RA 775 – Clinical Trials: Issues in Design, Conduct and Evaluation

Textbook: Get It Right the First Time! Pharmaceutical Product Development, Intelligent Solutions for Challenging Issues
Author(s): King, Bernard D.
Publisher: Macnas Press, 2010
Ordering Information: This book may be ordered directly from  Macnas Press. Enter the code “SDSURA” to receive a student discount. The discount code box will appear on the last checkout page, before payment information is entered.

RA 779 – International Regulatory Affairs

Textbook: Fundamentals of International Regulatory Affairs, 3rd Edition
Publisher: Regulatory Affairs Professionals Society, 2017
ISBN: 978-0-9969491-9-4
Ordering Information: This book may be ordered directly from RAPS. Students can purchase this book online at the student rate of $195.00 (US) plus shipping by using the discount code ‘SDSUBOOKS‘.

Textbook: Managing Cultural Diversity in Technical Professions
Author: Laroche, Lionel
Publisher: Burlington, MA: Butterworth-Heinemann, 2003
ISBN: 978-0750675819
Ordering Information: This book may be purchased from Amazon.

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 Extended Studies 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 Life Science Professionals

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. After you accept the “Ship-To-Home Textbook Agreement”, select the Extended Studies session in which you are registered, “Regulatory Affairs”, then “RA 783” and your instructor’s session.