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  • 1.  Free cmc course

    Posted 12-Jun-2019 06:52
    hi I came from Brazil where I worked in RA for 13 years. Here in US I will need to start my career again and I guess that CMC área for drugs will be the best option. Do you know any free course about it? Or about anything related to RA here in US? It is not being easy to get a job here without experience with FDA. Thank you

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    Elisa Hexsel Goncalves Steger

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  • 2.  RE: Free cmc course

    Posted 13-Jun-2019 16:03
    Hi Elisa, 
    Your best starting point for free resources would be the FDA website itself- there is a page dedicated educational resources at the following link: https://www.fda.gov/industry/fda-basics-industry/educational-resources

    Additionally, RAPS offers quite a number of webcasts, articles, and in-person training that be found on the RAPS website, under the Education and Events tab section, specifically the E-learning tab. 

    There are also numerous valuable training offered thru other well-regarded professional organizations such as DIA, ISPE, etc. 

    I hope this information is helpful for you!

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    Susan Shockey RAC
    Senior Manager, Regulatory Affairs and Quality Management
    Charleston SC
    United States
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    Original Message


  • 3.  RE: Free cmc course

    Posted 14-Jun-2019 07:42
    Edited by Jessica Kokosinski 14-Jun-2019 07:42
    Hi Elisa:

    Completely agree with Susan! The US FDA website is a great resource for free webinars and information and you will get a lot out of it. There are a few organizations which offer paid CMC training sessions and these include: DIA (Drug Information Association), CfPA (Center for Professional Advancement), CfPIE (Center for Professional Innovation & Education) - to name a few. 

    Also, there are colleges which offer RA programs and an advanced degree in Regulatory Affairs (as a Masters Degree or Certificate). A quick Google search will highlight these schools.  

    Brazil can be a challenging market to register drugs and biologics in. As such, I would think that many pharma companies and/ or consultancy firms would want to work with you with such a specialized skill set. Even though you may initially be supporting Brazil registrations, there may be opportunities (depending on the firm) for cross-training in other markets, such as the US.  So, I think there would be a lot of opportunity out there for a candidate with your background.

    Hope this is helpful!

    Thanks,

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    Jessica Kokosinski
    VP Regulatory Affairs
    Warren NJ
    United States
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    Original Message


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