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CMC RAPS Specialty

  • 1.  CMC RAPS Specialty

    Posted 27-Sep-2020 14:31
    Dear Regex,
    I think it will be of great value and importance to the community and the the RA professionals worldwide if RAPS develops a CMC specialty materials and exam.
    What is your opinion?

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------


  • 2.  RE: CMC RAPS Specialty

    Posted 05-Oct-2020 12:53
    I agree. I know some Reg-CMC folks who have gotten their RAC, but I personally find it to not be worth the effort since so very little of what is covered applies directly to CMC and so very much of it does not.

    Of course, after 27yrs in the industry and 18yrs in RA-CMC, I would not find it worth the effort to do it now even if they had one. But I would have welcomed it back when I started out, when I was desperate to get some kind of training in the field.

    ------------------------------
    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
    ------------------------------



  • 3.  RE: CMC RAPS Specialty

    Posted 06-Oct-2020 06:34
    Exactly! How do you think we can raise this issue to RAPS? Someone like you with your extensive experience could have a great contribution in developing such a certificate.
    I studied for RAC and received my credential this month but still in a bad need to study CMC in a program well designed by professionals in the field.
    I hope we can such a program available soon.

    -------------------------------------------

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 4.  RE: CMC RAPS Specialty

    Posted 06-Oct-2020 08:23
    I don't know. Anyone from RAPS able to offer suggestions?

    ------------------------------
    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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  • 5.  RE: CMC RAPS Specialty

    Posted 06-Oct-2020 11:34
    @Eileen Quinn any suggestions please?

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 6.  RE: CMC RAPS Specialty

    Posted 08-Oct-2020 09:57
    Hi @Alaa El Kazak, thanks for the tag! Let me look into this further and I will get back to you. ​​

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



  • 7.  RE: CMC RAPS Specialty

    Posted 08-Oct-2020 14:16
    Thanks alot. Waiting for your reply.

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 8.  RE: CMC RAPS Specialty

    Posted 08-Oct-2020 17:31

    Hi @Alaa El Kazak - RAPS offered some workshops on CMC in the past, and is planning to offer similar programs in Q1 and Q2 of 2021. You can learn more about what was covered in those workshops by viewing the following program descriptions:

    RAPS also offers an online course, Chemistry, Manufacturing and Controls (CMC), that also provides foundational information on that topic.

    Regarding your question about a specialty exam, we'll share your comments with the RAC Manager, @Pete Etchells, and you can feel free to follow up with him to discuss in more detail.

    ​​

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



  • 9.  RE: CMC RAPS Specialty

    Posted 09-Oct-2020 06:03
    @Eileen Quinn Thanks alot for your response. I'll followup on the subject.

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 10.  RE: CMC RAPS Specialty

    Posted 10-Oct-2020 12:43
    Thanks for posting the question. I am very interested in the conversation and plan on enrolling for the courses.

    ------------------------------
    Shailaja Kunda
    Research Professional, Neurology, Mayo Clinic
    Denver CO
    United States
    ------------------------------



  • 11.  RE: CMC RAPS Specialty

    Posted 11-Oct-2020 00:12
    Dear Shailaja,
    Thanks for your interest. I'll keep you posted for any updates.

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 12.  RE: CMC RAPS Specialty

    Posted 11-Oct-2020 13:03
    Dear @Pete Etchells , Could you please give us your insights about this subject? As it seems many share with me the same opinion. Thanks in advance.

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------





  • 13.  RE: CMC RAPS Specialty

    Posted 13-Oct-2020 11:16
    Hi Alaa El Kazak,

    It is wonderful to hear that there is interest in further credentialing opportunities in the regulatory profession. At the moment there is not any specific plans to create a CMC specific equivalent to the current RACs. However, the RAC Board is continually looking at the best ways to ensure the regulatory community is well served by RAC credentials and it may become possible in the future.

    Regards,



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



  • 14.  RE: CMC RAPS Specialty

    Posted 13-Oct-2020 11:58
    CMC concerns only Quality of a medicinal product.
    I think that CTD will better.
    The Efficacy & Safety will all be involved.

    ---------------------------------
    HuaChun Teng
    Pharmacist

    Tainan
    Taiwan
    ---------------------------------





  • 15.  RE: CMC RAPS Specialty

    Posted 13-Oct-2020 12:23
    @Pete Etchells Thanks alot for your response. It's good to know that you're following up. We appreciated well your decision -as board- to replace regional exams with sector specific exams based on the community calls. This has triggered me to raise a need for you to study. We always hope the best for the profession and the community.

    ---------------------------------
    Alaa El Kazak


    Jeddah
    Saudi Arabia
    ---------------------------------