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  • 1.  Conference focusing on FDA submissions

    Posted 17-Aug-2023 09:54

    Good morning,

    I was wondering if anyone could recommend a conference/event that focuses on FDA submissions for IND/IDE.  We are developing a program to do this on behalf of our investigators so I'm looking for any conferences that we would be able to attend to learn more.  



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    Jennifer Pennington

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  • 2.  RE: Conference focusing on FDA submissions

    Posted 18-Aug-2023 11:41

    Hi Jennifer,

    In response to your question on conferences for IND/IDEs, please check out Food and Drug Law Institute (FDLI) at fdli.org.  A link to their introductory Drug law program is below, they have the similar program for medical devices also. 

     

    https://www.fdli.org/2023/11/introduction-to-drug-law-and-regulation-fall-2023/

     

    Hope this is helpful,

    Judy

     

    Judy Kannenberg, MBA, RAC

    Vice President, RA Head, BioPharma and Labeling

    Astellas Pharma Global Development, Inc.

    224-515-6027 (mobile)

    224-205-5755 (FAX)

    judy.kannenberg@astellas.com

     

    astellas-logo-with-slogan-u_jpg

     

     




    Original Message


  • 3.  RE: Conference focusing on FDA submissions

    Posted 21-Aug-2023 16:40

    Hi Judith,

    If I understand your question correctly you're looking to create a program for clinical investigators, possibly in advance of clinical trials. If my understanding is correct then I'd encourage you to reach out to ARCP. They have local chapters, training programs, etc. and focus on clinical trials.  Association of Clinical Research Professionals - ACRP

    Regards,

    Roy

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    Association of Clinical Research Professionals - ACRP
    With more than 14,000 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit organization solely dedicated to representing, supporting, and advocating for clinical research professionals.
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    . 



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    Roy O'Kelly RAC
    President
    Hoffman Estates IL
    United States
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    Original Message