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  • 1.  Setting up a Study Group and RAC US Study tips please!

    Posted 19-Oct-2018 09:40
    Hello,

    I am a Regulatory Affairs Specialist in medical devices for the last five years and I have just recently started studying for the RAC US, any advice on how to approach this? I have recently worked with RAPS to set up Ireland's Local Netwroking Group, any suggestions for running a study group?

    Thank you!

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    Maria Connolly MPharm
    Regulatory Affairs Specialist
    Cerenovus
    Johnson & Johnson
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  • 2.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 22-Oct-2018 12:08
    Hi Maria:

    I have a few points that may help you:

    • Have a study group.
    • The study group should have no more than 15 people, no fewer than 8 people. 
    • Make sure that each member has enough time to do the work necessary to succeed with the test. The test is not easy; and, it will take time and dedication to ensure that you have the knowledge and strategic thinking skills necessary to pass the test. Although the test is multiple choice, it is definitely not easy. The test questions are in essay format and present different issues in the same essay. The multiple choice answers can be complicated. 
    • Make sure that each member of the study group is really going to take the test; and, that each member is dedicated. 
    • All the members of the group should study all the chapters.
    • In addition to all members studying all the chapters, divide up the chapters among the members. Each member should study in more depth their assigned chapters. Just studying the chapter is not enough
    • For their assigned chapters, each member should review some of the additional resources provided in those chapters.
    • Each member should develop a few different scenarios for each of their assigned chapters. Those scenarios should be a bit complex and include 4 different multiple choice answers.
    • Do independent research: look through the FDA website, especially look at warning letters; use a search engine and enter key words that are related - you will find a number of different articles on various websites that pertain to the regulations, most of which are real-life situations and how they were resolved.
    • During the exam, read the question thoroughly. Once you are confident that you understand the question, thoroughly read all the answer choices. Don't pick the first choice that makes sense. Make sure you read all the choices before choosing the answer, then select the best answer. One trick they use is to provide a scenario, then have three or four good answer choices, with the 4th or 5th choice being: "Make sure it actually happened."  In other words, make sure that what is described in the scenario actually happened before taking any Regulatory action. Do due diligence to ensure that the issue reported actually did occur and that, if it did occur, is it a Regulatory issue. This is the correct answer - make sure it happened.

    I hope these points help you. I have been in a few study groups; and, have observed others. These are from the lessons I've learned throughout the process. 

    Good luck,
    Kathryn

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    Kathryn Howland
    Regulatory Affairs Manager
    San Francisco Bay Area
    USA
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  • 3.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 23-Oct-2018 17:37
    I agree with Kathryn's suggestions for a study group. I have taken two RAC exams, one with a larger study group and the second with a single 'RAC buddy'. In both cases, though, we did exactly what Kathryn's suggests - we listed out the chapters of the book, assigned a chapter or two per week (depending on how much time there was before the exam), and made one group member responsible for being the "leader" of each week's discussion. Laying out the study schedule in this way really makes it clear that you need to stay focused and keep up with your reading each week, as a lapse of even a week or two will make it hard to catch up. Having a schedule makes everyone accountable for getting their reading done on time, and being prepared to participate in that week's discussion. The leader would pull together relevant regulations, standards, and other resources to help the group better understand that week's content - keep in mind that the Fundamentals books are a good guide, but do not necessarily contain all the information you'll need to fully understand each topic.  

    Good luck!

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    Jennifer Cabralda, RAC (US, CAN)
    Richmond, BC, Canada
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  • 4.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 23-Oct-2018 09:12
    Hello Maria, 

    I am a Reg Specialist at a medical device manufacturer. I am considering taking the RAC exam next spring, but I am leaning towards this new medical device-specific one that appears on the RAPS website now. It covers US, EU and other "globally applicable regulatory practices."
    https://www.raps.org/RAPS/media/RAC-Credential/Resources/2019-RAC-Candidate-Guide-Devices.pdf

    Any chance you would prefer to pursue that exam instead of the RAC-US exam?




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    Katherine Doll Kanne
    Minneapolis MN
    United States
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  • 5.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 24-Oct-2018 07:24
    Hi all,

    Thank you so much for taking the time to provide feedback, I really appreciate it and its very helpful!

    Katherine, thanks for highlighting the RAC Devices, I did consider this but I have decided to pursue the RAC US. Best of luck in your exam.

    Thanks again everyone.


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    Maria Connolly MPharm
    Regulatory Affairs Specialist
    Cerenovus
    Johnson & Johnson
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  • 6.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 24-Oct-2018 12:46
    Hi Everyone, 
    Just thought I'd throw my 2 cents in as well!
     In my previous job, I led RAC study sessions for my company for several years. 
    Our best results came when we followed the ideas expressed above, whereby we assigned chapters to individuals, and that person would lead the discussion.  As stated, having the schedule and accountability really helped keep everyone on track. 
    I'd like to share one additional thing we did- we had the leader for each chapter make up 10-15 questions, following the RAC exam format. We then answered the questions as a group, and discussed which answer was best, and why.  It helped everyone to be thinking in the form of application questions, and the discussions around the answers really provided a beneficial learning opportunity. 
    Of course, the sample questions provided by RAPS are very useful as well. 

    Hope this helps, best wishes to all as you study!

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    Susan Shockey, RAC
    Regulatory Affairs and Quality Management
    Charleston SC
    United States
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  • 7.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 19-Nov-2018 11:21
    Thank you so much Susan and all!

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    Maria Connolly MPharm
    Regulatory Affairs Specialist
    Cerenovus
    Johnson & Johnson
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  • 8.  RE: Setting up a Study Group and RAC US Study tips please!

    Posted 19-Nov-2018 15:05
    Edited by Emily Stamm 19-Nov-2018 16:06
    Hi Maria,

    I wanted to reach out and let you and anyone else viewing this thread know that we have a dedicated community for answering your questions about the RAC, including whether it's right for you, preparing for the exam and recertifying your credential.

    If you are interested, please send me a message so I can add you to the RAC community. 

    Best,
    Emily

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    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
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