Visit us at RAPS!

Planning on attending RAPS Convergence 2017 on September 10th-12th at National Harbor? If so, come see us! We’ll be at Table 12.

May ’17 courses open to Regulatory Professionals!

Regulatory professionals may take our May ’17 elective courses for professional development… [Read more…]

No More GRE?!

The GRE requirement can now be waived for applicants who meet one of the following criterion:

  • have an undergraduate GPA of at least a 3.0 and 3 yrs. of relevant industry experience
  • have completed three program courses (one of which must be RA 602) with a grade of B or better in each course
  • hold an advanced degree (such as an MBA, MS, MA, Ph.D., JD, etc.) from an institution that is a member of the Council of Graduate Schools.

Contact the Graduate Advisor at lbodie@mail.sdsu.edu for more information.

Testimonials from our Students!

Graduates Ana Freed and Dr. Ken Kern share their thoughts about our program.

Come see us at AWIS SD Open House!

SDSU Regulatory Science will be at the Annual AWIS (Association for Women in Science) SD Open House on Wednesday, October 28th from 5:30pm-8:00pm. We hope to see you there!

Interested in Regulatory Science as a Career?

Interested in Regulatory Science as a career? Come see us at the SDSU 2015 Graduate & Professional Schools Fair on Thursday, Oct. 15, 10 AM – 2:30 PM, at the North Love Library Terrace.

 

 

 

New Joint Certificate in Intellectual Property & Regulatory Affairs

SDSU and USD School of Law are partnering on an innovative new certificate in Intellectual Property & Regulatory. This program is the only one of its kind in the US. Applications are being accepted for Spring ’16. For more information, visit regsci.sdsu.edu/ipra

New Electronic Submissions Course Starting May ’16!

Electronic Submissions Course Starting May 2016!

This is a new for-credit course that can meet elective requirements for current students or be taken for professional development by those working in Regulatory Affairs.

To register for this course, go to Courses-Register for a Course. The course cost is $2250. For more information, contact Ana Righellis, Program Coordinator, at 619-594-6030.

Introduction to Eleshutterstock_eCTDSubmissionsctronic Submissions (3 units – $2250; May 16th – July 17th)
This course will provide an introduction to current and future elements of electronic submissions for drug, biologic, and device submissions to health authorities. Electronic Common Technical Document (eCTD) and eCopy format will be covered. The course includes software instruction and a practicum to give students the opportunity to create content, assign content to an XML backbone, hyperlink documents, and validate compliance.
Instructor: Dr. Mitchell Seymour

This course requires docuBridge ONE software from LORENZ. 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.) 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 can apply a $300 credit towards the purchase of a full software license within 90 days of the course conclusion. In addition, the course requires Adobe Acrobat Pro, also available at student pricing through the SDSU Bookstore.

Changes to RA degree requirements

Effective Fall 2014, Regulatory Affairs program curriculum will change slightly. RA 705: Project Planning for Biomedical Industries will become an elective course and RA 775: Clinical Trials will become required. This change will not affect students who already have a Program of Study. [Read more…]

“Hot Topic” Courses in Regulatory Science

Three-week, 1-unit “hot topic” courses will be offered beginning Summer 2014!

These are for-credit courses that can meet elective requirements for current students or can be taken for professional development by Regulatory Affairs professionals. [Read more…]