RAC Workshops

One of the more valuable of our NCRAF membership benefits is the annual Regulatory Affairs workshop. NCRAF has the support of very knowledgeable speakers who donate their time each year to share their experience and bring the regulations to life. This workshop is ideal for those who would like to broaden their understanding of FDA regulations, earn CEU's for the RAC certification currently held, or prepare for taking the RAC exam.

NCRAF's  RAC Workshops have been redesigned to accommodate the new structure of the RAC exams.  NCRAF will offer a drugs/biologics series and a medical device series; these will run in parallel (and will share some joint lectures).

2024 Workshop Dates & Location

This year, we are revising the workshop format to try to better serve the needs of registered attendees, while also respecting the time that instructors donate for this series. In recent years we have noted that attendees have been largely utilizing the recordings offline, rather than attending the live, scheduled lectures.  Therefore, since the regulations don’t change that much in one year, this year we will not present live lectures; the workshops will comprise of previously recorded lectures.

To facilitate participants' understanding of the material, we have reorganized the lectures into "chapters" of related topics, and will hold monthly (live via Zoom) Q/A sessions with a subset of the instructors. Each Q/A session will be focused on the topics covered in a different “chapter”.  The default format for these Q/A sessions will be open office hours for the attendees to bring any questions prompted by the lectures. 

We will open registration in May for this series with the first “Q/A session” in late June. See Q/A session listings in the registration confirmation email and on the calendar.

Registration & Fees

Any NCRAF Member may register for the workshop. There is a workshop fee of $75 .

Members: if you are a current NCRAF member, please log in with your username and password, then register through the website's HOME PAGE.

Non-Members: Before you can REGISTER for the RAC, you MUST be an NCRAF Member.  To join NCRAF click on the button "Become a New Member" at the right of the page so that you are properly listed in our membership database.

 

THEN, log-in and register for the course through the Home Page of the website. 

Additional Information

The cost of the RAC exam (~$500; administered by RAPS) is not included in the study group fee. Please see the RAPS Web site (www.raps.org) for registration information, including exam costs and locations.

If you are planning to take the RAC exam, purchase of the current edition of Fundamentals of US Regulatory Affairs (published by RAPS) is highly recommended.

If you have no immediate plans to take the exam, the suggested readings and course materials will supply sufficient background for the group discussions.

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