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May 22 from noon to 12:30 pm ET - 30 Minutes, One Question: Where Should Regulatory Science Focus?

  • 1.  May 22 from noon to 12:30 pm ET - 30 Minutes, One Question: Where Should Regulatory Science Focus?

    Community Leadership
    Posted 20 days ago
    Join the Regulatory Science Community for 30 minutes and one question: where should Regulatory Science focus its energy this year?
    As the connector community across AAPS, we sit at the intersection of nearly every scientific theme - which means we get to be deliberate about where we lead, collaborate, and add the most value.
    No prep, no slides. Bring one idea, one challenge you're seeing in the field, or just an open mind.
    Can't make it? Reply to this thread and we'll add it into the discussion.
    ________________________________________________________________________________
    Microsoft Teams meeting
    Meeting ID: 235 042 413 308 118
    Passcode: 2Um3pz2X
    Dial in by phone
    +1 240-752-9082,,947425991# United States, Bethesda
    (833) 851-0265,,947425991# United States (Toll-free)
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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: May 22 from noon to 12:30 pm ET - 30 Minutes, One Question: Where Should Regulatory Science Focus?

    Posted 19 days ago

    Hi Allison,

    A few focused areas where I believe Regulatory Science can make a meaningful impact:

    • Establishing clear, risk‑based expectations for AI and Digital Twin credibility, validation, and lifecycle management, especially as these models begin influencing CMC and GMP decision‑making.

    • Modernizing specifications and control strategies for complex products, including how model‑informed approaches, PAT, and advanced analytics can be incorporated into regulatory frameworks.

    • Providing regulatory clarity for the use of Digital Twins in PPQ and tech transfer, including documentation expectations, change‑control triggers, and criteria for model updates or retraining.

    Happy to expand on any of these if helpful.

    Best, Bhasker



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    Bhasker Sambar
    Sr. Manager, External R&D and Technical Services
    Alvogen INC
    Exton 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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