Regulatory Open Forum

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  • 1.  Beginner in Regulatory effairs

    Posted 13-Feb-2017 11:12

    Hello

    I am new to RAPS Forum. I want to make a mark in this field and start a carrier in Regulatory department for either pharmaceutical products or Medical devices. By profession I am a PhD Scientist, currently working in a pharmaceutical industry.

    I am going to appear for its certification in coming months. I will really appreciate if I can get a guidance how to study as a beginner.

    Best regards and thanks
    Pratima


  • 2.  RE: Beginner in Regulatory effairs

    Posted 13-Feb-2017 11:39
    Hi, Pratima,

    Fundamentals of US Regulatory Affairs is the best for preparing for the US RAC exam.  Know the Comparison Matrix in the back of the book in its entirety.  Use that section to make flash cards.

    RAPS has a practice exam to tell you what areas you are weak in and need to concentrate on.  Take that first.

    There are older exam questions available on line you can find using different key search words.  Some have answers and some don't.  Be careful because some of the ones with answers are not necessarily correct.  There are also some flash card decks available on line and again double check to make sure all the answers are correct before you use them.

    Working with a study group is great.  We used a free on line video-conferencing service but later just went with audio calls.  We started with 20+ people and many quickly dropped out leaving about 8 truly dedicated people in the group.  Having people with different backgrounds helps so the device people can help the pharma people and vice versa.  We studied from 8 pm until 10 pm three nights a week for close to 3 months. If I remember correctly over half of us passed the first time we took the exam. 

    Some local chapters have preparation courses to provide insight and test taking strategies.  Check around on the RAPS Events web page.

    Gook luck!

    ------------------------------
    John Minier, RAC
    Director
    Minier Medical Device Consulting, LLC
    john@johnminier.com
    Highland Mills NY
    United States
    ------------------------------

    Original Message


  • 3.  RE: Beginner in Regulatory effairs

    Posted 14-Feb-2017 13:41
    Thanks a ton John for your suggestions. I will look up for RAPS events and also will look around for more beginners to have a study group.
    Best regards and thanks
    Pratima



    Original Message


  • 4.  RE: Beginner in Regulatory effairs

    Posted 15-Feb-2017 09:27

    I am looking for beginners in RAPS. Those who are planning to appear for an exam in coming months. I will really appreciate if those who are interested in forming a study group can come up and reply here or email me separately at pratimabharti@gmail.com.
    Looking forward for a response.
    Thanks
    Pratima



    ------------------------------
    Pratima Bharti, PhD
    Kalamazoo MI
    United States
    ------------------------------

    Original Message


  • 5.  RE: Beginner in Regulatory effairs

    Posted 16-Feb-2017 09:56

    The New York/New Jersey regulatory community will be conducting a full day US RAC Overview Session on Saturday March 11th that will help you prepare for the April/May 2017 testing cycle. The session will be facilitated by a panel of certified regulatory professionals and is crafted to provide an overview of the exam. The session is limited to 40 onsite participants and there a few seats still available for our session. http://www.raps.org/EventDetail.aspx?id=26476.  

    As an added bonus, participants of this session will have access to an online community of fellow RAC test takers who will attend this same session offered by the Atlanta Chapter on Saturday March 18th. The collaboration of those from Atlanta (primarily medical device focused) and New York/New Jersey (primarily pharma focused) will result in a more diverse community of professionals to engage with. http://www.raps.org/EventDetail.aspx?id=26598

    It is highly recommended that you have a minimum of two to three years regulatory experience, as the content will be positioned with the expectation that attendees have a basic understanding of the regulatory profession. We strongly recommend that you purchase the Fundamentals of US Regulatory Affairs, 9th Edition and bring the book with you. Continental breakfast and lunch will be provided.

     

    Participation in this RAC session should not be your only method of exam preparation. RAPS provides many exam preparation materials which can help you develop a comprehensive study plan. With your registration, you will be automatically added to an online community on Regulatory Exchange where you can discuss RAC preparation with others. Details to gain access to this community will be provided during the event.

     

    Linda Bowen

    Chair NJ NY RAPS Chapter

    On behalf of our RAC Facilitators in NJ and Atlanta

     

     




    Original Message


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