Regulatory Open Forum

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  • 1.  peer reviewed articles/journals

    Posted 14-Dec-2016 05:20

    Hello,

    Can someone please advise me on the best journals for Regulatory Affairs peer reviewed articles? Thanks,

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    Amelie Sylven,Switzerland
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  • 2.  RE: peer reviewed articles/journals

    Posted 15-Dec-2016 14:29

    Amelie,

    I am not sure which is best, but I do browse the monthly "Therapeutic Innovation & Regulatory Science" published by the DIA and find it quite informative.

    Maurizio

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    Maurizio Franzini
    Gilead
    Foster City CA
    United States



  • 3.  RE: peer reviewed articles/journals

    Posted 19-Dec-2016 14:25

    I have to say that until now I didn't know there were any peer-reviewed regulatory journals.  Kudos to DIA for sponsoring one.  I tend to steer clear of anything waving the bzzy "regulatory science" banner about, but I see they do have one FDAer on their board, so maybe they are using the term in a manner I'd accept as legitimate.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 4.  RE: peer reviewed articles/journals

    Posted 20-Dec-2016 10:12
    Edited by Michael Hamrell 20-Dec-2016 10:14

    The DIA Journal is now in its 50th year of publication of peer-reviewed articles in regulatory affairs and drug development.  they routinely publish articles authored by FDA, EMA, PMDA and other regulatory agencies, as well as experts from various companies and academic experts in the industry.  They recently published a series of articles from the TransCelerate group that considers TIRS to be the best place to publish their findings and reach the regulatory audience.

    i would think that this makes it legitimate, as you call it.

    PS:  full disclosure - I was the former editor in chief for 6 years.

    ACRP also publishes a bimonthly journal, Clinical Researcher, that includes peer-reviewed articles, mainly focused in clinical research issues.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    MORIAH Consultants
    Huntington Beach CA
    United States



  • 5.  RE: peer reviewed articles/journals

    Posted 30-Dec-2016 04:36

    Michael, thank you for the additional information on the DIA Journal.

    To clarify, I wasn't referring to the legitimacy of the journal itself, but only to its use of the term "regulatory science."

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com