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2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

  • 1.  2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 18-May-2020 16:28

    Hi RegEx members,

    In case you missed it, the RAC board is excited to announce that you can now take the RAC exam online during the summer exam window!

    In support of this change and to ensure that all of your questions about this new option are answered, we will be hosting an "Ask Me Anything" session on Tuesday, 2 June, from 1:30-2:30 PM on RegEx. Our expert for the session will be Pete Etchells, Senior Manager of the RAC Program. Pete will answer all of your questions about the new testing option for the summer 2020 exam window. Please note, Pete will not answer questions on prepping for the exam.

    If you cannot make the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org. All of your questions will be answered on this thread at the time of the event. 

    Looking forward to seeing your questions!

    Best,

    Annie



    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------


  • 2.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 29-May-2020 10:47

    Hi RegEx,

    We have an exciting update to the AMA: Herb Anthony, Director of Education and Professional Development at RAPS will be joining to help answer any questions you have about prepping for the RAC exam! If you cannot make it during the session, please feel free to submit any questions ahead of time by sending me an email at regex@raps.org.

    Looking forward to Tuesday!

    Best,
    Annie



    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 3.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 01-Jun-2020 01:04
    Hi Annie,

    Could you kindly confirm the details for attending the session.

    Regards,
    Shikha

    ---------------------------------
    Shikha Malik
    Regulatory Affairs Specialist II

    Dallas TX
    United States
    ---------------------------------





  • 4.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 01-Jun-2020 08:52
    Hi Shikha,

    The session will take place on this thread on RegEx! Pete and Herb will respond to questions posted to the thread tomorrow from 1:30-2:30 PM ET.

    Best,
    Annie


    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 5.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:30

    The AMA is starting--post your questions for out experts below!



    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 6.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:38
    Hi!

    I need to study wisely for the exam, so I would like to know... Can you recommend the best resource(s) for studying? I've done the presentations and purchased the 4 books. Is the new edition of the Global Pharmaceutical and Biologics Regulatory Strategy a good overall resource for the test? 

    Thanks,
    Lisa

    ------------------------------
    Lisa Carlson
    Land O Lakes FL
    United States
    ------------------------------



  • 7.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:23
    Hi Lisa,

    Study resources will depend on your individual industry experience, your personal learning style and any Regulatory Training you may have completed. Books will have useful information to help you study, but it may also help to first take an inventory of what you already know.  Please review the Exam Content Outline in the Candidate Guide to help you further assess your current knowledge and areas for more review.
    https://www.raps.org/rac-credential/applyrac/how-to-apply-for-the-rac










    ------------------------------
    Herbert Anthony
    Rockville MD
    United States
    ------------------------------



  • 8.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:39
    Hi.  I am planning to take the RAC exam online this summer. My system has already met the requirements as per examity system check. I am trying to check if there is any other sample exam test to see if my system works for the online exam.  If there is any technical difficulty during the exam, how do i get the help needed.

    ------------------------------
    Swathi Jampani
    R&D Scientist
    San Rafael CA
    United States
    ------------------------------



  • 9.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:49
    Edited by Eileen Quinn 02-Jun-2020 13:49
    Hi Swathi,

    Thanks for the question. Just prior to the exam the proctor will do a final check to make sure that your system meets requirements. There is support available from the proctor and through email and phone for candidates taking the online exam. Those support services will work with candidates having any technical issues. . If a candidate has any doubts about this they should consider taking the exam at a testing center. 

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 10.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:28
    Hi! I applied for spring exam and due to covid application has been post pined to summer exam window. How canI choose for online exam? Thank you.

    ------------------------------
    Sonia Callegaro
    Regulatory Affairs Specialist
    Tolochenaz
    Switzerland
    ------------------------------



  • 11.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:32
    Sonia, Thanks for the question. In early July, summer exam window applicants will receive the Notice to Schedule email, this email allows candidates to schedule their exam. When choosing date and time, candidates will also choose whether to take the exam at a testing center or to take the exam in the online format.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 12.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:41
    👍🏼 Thank you 😊

    ------------------------------
    Sonia Callegaro
    Regulatory Affairs Specialist
    Tolochenaz
    Switzerland
    ------------------------------



  • 13.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:32
    What are the exact test dates for the summer window? I want to see if the date works for me.

    ------------------------------
    Mahshid Nikbakht
    CA, USA
    ------------------------------



  • 14.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:34
    Hi Mashid, thanks for the question. To apply for the summer exam you must have completed your application by 18 June 2020. The exam window, when you can take the exam, is from 13 July–21 August 2020. For a full list of future exam windows see https://www.raps.org/rac-credential/applyrac/how-to-apply-for-the-rac

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 15.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:36
    How much time should be allowed to schedule testing during this time - can you select a testing date that is 24 hours out or must it be further out?

    ------------------------------
    Scott Bishop
    Houston TX
    United States
    ------------------------------



  • 16.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:43
    Hello Scott. For Online exams candidates must schedule their exam 2 calendar days in advance. For testing center based exams scheduling needs to be done 4 calendar days in advance. Please note that all exams are subject to availability and we recommend that candidates schedule their exams as early as possibly to avoid missing out on their preferred exam time and date

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 17.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:38
    What are the best sources available from RAPS to use for exam preparation? Are there some practice exams available?

    ------------------------------
    Eugene Helsel
    Principal Consultant, Halloran Consulting Group
    ehelsel@hallorancg.com
    ------------------------------



  • 18.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:49
    Edited by Herbert Anthony 02-Jun-2020 13:57
    Hi Eugene,

    Thank you for taking the time to reach out to RAPS.  There are currently Practice Exams available online at RAPS.ORG.

    Kind regards,

    Herb Anthony
    Director, Education and Professional Development

    ------------------------------
    Herbert Anthony
    Rockville MD
    United States
    ------------------------------



  • 19.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:46
    RAC Devices Summer Exam: Will the exam cover only EU MDR and IVDR or even the Directives (MDD, AIMDD and IVDD)?

    ------------------------------
    Shalin Parikh
    Germantown MD
    United States
    ------------------------------



  • 20.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:49
    Hi Shalin. For obvious reasons I cannot share any specific topics that may or may not be on the exam. However, each year's RAC exams are based on regulations 'on the books' on December 31 of the prior year. I believe that would potentially include all of the topics you mention in your question.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 21.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:47
    Can we have more details on how we can participate in the online test in the Summer? Will this option be available in the Autumn testing window?

    ------------------------------
    Mahshid Nikbakht
    CA, USA
    ------------------------------



  • 22.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:51
    Hi Mashid, thanks for the question. The first step to taking an RAC exam online is to register for either the RAC Drugs or the RAC Devices for the summer 2020 exam window. In early July, about 10-14 days before the testing window begins, registered candidates will receive a 'notice to schedule' email from Scantron. At that time they will be able to choose whether to take the exam at a testing center or online using live online proctoring, in addition to their preferred date and time.

    Online RAC exams are being offered as a pilot program in response to the COVID-19 pandemic. The summer 2020 exam window will offer candidates the option to take the RAC exams online or at a testing center. At the end of the summer exam window, the RAC Board will make a decision about whether or not online testing will be offered for future exam windows.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 23.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:54
    In the case of technical difficulties such as dropped connection, power outage, etc. what is the policy? Can the test be resumed or must the test taker reschedule and begin the testing process again? Is additional payment required?

    ------------------------------
    Scott Bishop
    Houston TX
    United States
    ------------------------------



  • 24.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:58
    Thanks for the question. There is support available from the proctor and through email and phone for candidates taking the online exam. Those support services will work with candidates having any technical issues. We will work with any candidate should difficulties arise, and do not anticipate a situation where we would expect additional fees or payment in the case of technical difficulty. We strongly recommend all candidates considering taking the online exam do a thorough check that their system meets the requirements in advance of taking the exam. If a candidate has any doubts about this they should consider taking the exam at a testing center.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 25.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 13:56
    I did receive the email about taking the RAC exam online, but a little concerned about network connectivity at home. Will we be given extra time as sometimes electricity can be cut/bandwidth may be low and I may not be able to proceed further. How do we handle such issues?

    ------------------------------
    Mekala Govindarajulu
    Consultant
    Chennai
    India
    ------------------------------



  • 26.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:00
    Hi Mekala, There is no additional time for taking the online exam. If you do not have good connectivity I would strongly recommend that you DO NOT take the exam at home, and use a testing center instead. Alternatively, if you have access to another location (a work office for example) that has better internet you could look to take it there. Please make sure the location meets the requirements for online testing (quiet, private etc.)

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 27.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:03
    Should I need to opt for online exam at home, what will happen if there is internet disconnection? As the exam period is 1 hour.

    ------------------------------
    Hui Jen Chua
    Kuala Lumpur
    Malaysia
    ------------------------------



  • 28.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:11
    Hi Hui Jen, The exam has a two hour time limit, but prior to the exam starting you will have an orientation process with the proctor when taking an online exam. If your internet connection is not strong and consistent I would recommend looking at taking the exam at a testing center, or an alternative location with strong and consistent internet. In the case of an internet disruption during an exam the proctor and support team will work with a candidate to come to a solution. The solution will depend on the specific situation at the time of the disruption.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 29.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:07
    Edited by Eileen Quinn 02-Jun-2020 14:20
    Preparing for the exam:
    I signed up for the USA drugs exam so Qs will be on general international/global/USA/EU drugs as per the % regional content breakdown. I have not covered Canada per se (I do not work in this country) is that ok? Canadian material was in the toolbox I purchased, but I did not feel it warranted an in-depth review for the exam, as it was included as material for general research/application.

    ------------------------------
    Carey Brett
    Consultant
    Austin TX
    United States
    ------------------------------



  • 30.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:12
    Hi Carey, There are no Canada specific questions on the Drugs RAC. The knowledge required and regulatory basis of the drugs exam is as follows:
    -Knowledge of the full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
    -Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and globally applicable regulatory practices* (40%). (*ICH, IGDRP (Generics) and WHO guidelines and standards).
    -Critical thinking and analytical skills.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 31.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jul-2020 09:04
    This message was posted by a user wishing to remain anonymous

    I did not purchase the toolbox but I did purchase the books (Vol 1 and Vol 2). Vol 1 covers US and Canada. Vol 2 covers EU & International. Based on the response above (30% US, 30% EU, 40% International), is it safe for me to skip Canada content from Volume 1 as I prepare for Drugs RAC ?

    I really appreciate clarification. 

    Thank you.


  • 32.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 01-Jul-2020 10:07
    Hi,

    You are correct that the exam content is 30% US, 30% EU, 40% International and that the Canada content of the Fundamentals books are outside the scope of the RAC exams.  

    Thanks 


    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 33.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jul-2020 08:11
    This message was posted by a user wishing to remain anonymous

    Thank you for clarifying, Pete. I appreciate it.


  • 34.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2020 10:02
    This message was posted by a user wishing to remain anonymous

    Hello,
    Apologies for a late question.
    I am preparing for RAC Drugs exams and purchased the Fundamentals of Pharmaceutical and Biologics Regulations books (Vol 1&II). Although the books appear to be specific for pharmaceuticals and biologics, there are some chapters such as GCP and GMP which includes content on Device clinical trials and Device CGMP. Since the exam is focused on Drugs, I am assuming these portions related to devices can be ignored as part of Drugs RAC preparation. It will be great if you could confirm if my understanding is correct.
    Thank you!


  • 35.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 24-Sep-2020 10:15
    Hi

    The Drugs exam focuses on drugs (pharma and biologics) questions. There may be combination products questions, although these would focus on the drugs side of that product, but otherwise you should not expect to have any questions regarding device knowledge on the drugs exam. The opposite is true for the device exam.

    Please also note that while the fundamentals books can be a good resource for preparing for the RAC, they are not a text book, nor are they the basis for the content of the RAC exams. Please review the RAC Candidate Guides, including the full Exam Content Outline to see the full scope of the exam.

    Thanks

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 36.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:09
    I booked the RAPS exam -Spring session. However, unfortunately, the exam that will be held in Beijing, China was cancelled due to the COVID19 disaster. Thus I re-booked a RAP exam -Summer session. The exam venue is in Beijing. Hope everything goes well and the exam can be held as we expected. So far, I did not receive any notifications for cancellation of the Summer exam session. Regarding the exam, I noticed that the new version of exams includes DRUG and MD sessions instead of the old-version exams. I purchased exam books as the official website recommended. May I confirm if all the recommended books, exam instructions, and online RAPS tests are all the exam preparation materials? If there are any other learning materials, where is the best place to find them?

    ------------------------------
    Yan ZHOU MD, MSc
    Beijing
    China
    ------------------------------



  • 37.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:15
    Yan, Thanks for the question. One area you may want to consider is reviewing the regulations themselves. There are also often study groups developed here on RegEx with people getting ready for the next exams - If check RegEx regularly there are often posts for people looking to set up online study groups. .

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 38.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:14
    What if after performing system check to ensure all is well you encounter a tech glitch (such as malfunction of web camera, microphone, and/or speakers) while taking the exam. Will that be counted against you?

    ------------------------------
    Pamela Nge
    Toronto ON
    Canada
    ------------------------------



  • 39.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:17
    Thanks for the question. There is support available from the proctor to deal with unexpected situations and also through email and phone for candidates taking the online exam. Those support services will work with candidates having any technical issues. We will work with any candidate should difficulties arise. However, we strongly recommend all candidates considering taking the online exam do a thorough check that their system meets the requirements in advance of taking the exam. If a candidate has any doubts about this they should consider taking the exam at a testing center.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 40.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:15
    Does the new testing options impact exam preparation?

    ------------------------------
    Eugene Helsel
    Principal Consultant, Halloran Consulting Group
    ehelsel@hallorancg.com
    ------------------------------



  • 41.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:18
    Hi Eugene, Thanks for the question. There is no difference in the exam content whether taking the exam at a testing center or taking it online. I do not see any reason why it should impact preparation.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 42.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:23
    Logistics:
    As there will there be a limit on numbers taking the test, can priority be given to those who have already suffered a cancellation?
    What level of proctoring is being provided: is it one to one?
    How will you need to confirm identity via webcam sight of documents too?
    Will you have a pre-test session on exam day to ensure everything works before you begin the exam?
    Confirm that trouble shooting is via the proctor only during the test for technical or other issues?
    What if you get sick at the last minute can you postpone?
    Reminder of timing: is it a two hour test?
    Did I read the exam will be available to take 24/7 for the exam window?
    If you complete early can you leave the exam early?
    I clicked on the following link and it appeared to verify that systems were ready and speed was acceptable is that all I need do for the system check? https://prod.examity.com/systemcheck/check.aspx

    ------------------------------
    Carey Brett
    Consultant
    Austin TX
    United States
    ------------------------------



  • 43.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:26
    Hi Carey, Thanks for your questions.
    1- There are no limits on taking the test per se, however scheduling can be limited at testing centers by number of seats available and online by number of proctors available. All this means in practice is that you need to schedule your exam as early as you can after your receive your notice to schedule email.
    2- Online examinations have a dedicated proctor.
    3 - id will need to be verified prior to starting the exam with a govt. issued ID.
    4 - Yes there is a pre-test orientation with the proctor who will check your system for functionality and explain the rules and processes.
    5 - The proctor is available during the exam to help with any technical issues, there is also phone and email provided in case they are needed for support.
    6 - The exam is two hours, the two hours doesn't begin until you have completed all the orientation with the proctor.
    7 - Online exams can be taken at any time, test centers have office hours that vary from center to center.
    8 - Yes you can complete the exam early if you wish.
    9 - the systems check is a good once over for your system and your system should be capable for online exams. Please check the full list of system specification in the Candidate Guide to make absolutely sure your system is compliant. Also note that the check cannot verify the consistency of your internet service.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 44.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:45
    Thank you Pete and Annie, this is very helpful!
    Carey

    ------------------------------
    Carey Brett
    Consultant
    Austin TX
    United States
    ------------------------------



  • 45.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:24
    How are the questions going to be formatted? Are they all multiple choice answers? Are there sample questions for the paper format that we could see to help prepare? Where can we find sample questions?

    ------------------------------
    saritha akinapalli
    Fremont CA
    United States
    ------------------------------



  • 46.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:30
    There are 100, multiple choice questions on the exam. For full details see the Candidate Guides (p.4) Candidate Guides are available here https://www.raps.org/rac-credential/applyrac/how-to-apply-for-the-rac . RAPS offer a practice exam that will give some ideas as to question formating. They can be found here - https://www.raps.org/rac-credential/prepare/rac-prep-tools

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 47.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:28
    1) When we select a date for the exam, is the time set or can we choose whenever we'd like to start?
    2) I understand the European MDR is part of the exam. Is the European IVDR part of the exam as well?
    3) Is it okay to use a headset?

    ------------------------------
    Dorothee Eckert
    Senior Manager - Regulatory Medical Devices
    Gauting
    Germany
    ------------------------------



  • 48.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:30
    1) Candidates will select the date and the time (subject to availability).
    2) The exam covers content on regulations that were 'on the books' as of December 31 of the previous year, if so it can potentially be on the exam. However, I cannot say which topics will or will not be on the exam
    3) Candidates are not allowed to wear a headset.

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------



  • 49.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:35

    Thank you all for joining us for this great session and a big thank you to our experts Pete and Herb!

    As a reminder, you can learn more about the online testing option for the RAC summer 2020 exam window here.

    Thanks again!

    Annie



    ------------------------------
    Annie O'Brien
    Community Manager
    Regulatory Affairs Professional Society
    regex@raps.org
    ------------------------------



  • 50.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 14:56
    Edited by Ilker Oztop 02-Jun-2020 14:58
    Hi there (apologies for the late question!). I would like to confirm how the scoring is done: As per the candidate guide (dated July 2018, https://www.raps.org/RAPS/media/RAC-Credential/Resources/2018-RAC-Candidate-Guide.pdf), "All scores are reported on a scale of 0 to 99 with 75 being the passing score". Does this passing score pertain to the RAC exam overall, or are candidates required to achieve a passing score in all three knowledge domains listed below independently?
    - US FDA requirements (30%);
    - European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and
    - globally applicable regulatory practices* (40%). (*ICH, IGDRP (Generics) and WHO guidelines and standards).
    Thank you!

    ------------------------------
    Ilker Oztop, PhD
    Brooklyn NY
    United States
    ------------------------------



  • 51.  RE: 2 June 2020 Ask Me Anything Session on RegEx: RAC Exam

    Posted 02-Jun-2020 15:32
    Hi Ilker,
    The score is not broken down by geography and there are no scoring requirements per area. Passing is solely based on the total number of questions answered correctly.

    Thanks

    ------------------------------
    Pete Etchells
    Senior RAC Manager
    Rockville MD
    United States
    ------------------------------