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Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area

  • 1.  Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area

    Community Leadership
    Posted 20 days ago

    Hello everyone,

    One of the Regulatory Science Community's focus areas is Global Harmonization & Submission Strategy, and we're partnering with the Global Health Community to build it out.

    We're looking for people who:

    • Follow regulatory guidance outside the US (Canada, Japan, China, EU, India, or anywhere else)
    • Would like to start following ex-US guidance, or
    • Simply want to learn alongside others

    You don't need to be an expert - interest is enough. We need help shaping programming (sessions, webinars, panels) and writing for these topics, and we'd especially welcome a range of regional perspectives. Students are welcome to get involved!

    If any of this sounds like you, please contact Allison Radwick or Mark Arnold for Regulatory Science, Erica Schlesinger or Sraven Kumar Patel for Global Health or just reply to this thread.

    Thank you!

    The Regulatory Science and Global Health Communities



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    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    Coatesville PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area

    Posted 19 days ago

    Hi Allison,

     

    Because of my work, I follow the following reg. agencies - FDA, HC, MHRA, EMA and NMPA and the following entities: ICH, WHO and OECD. And I am presently working with University of Hertfordshire on global regulatory harmonization projects along with TOPRA and RAPS. So, I will be interested to help.



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    Robert Falcone
    PhD, FRAPS, FTOPRA


    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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