RegulatoryScience Community

  • 1.  Join us September 25 noon to 1pm ET for a Perspectives about Global Harmonization

    Community Leadership
    Posted 19 days ago

    How do global standards become local requirements? Where does harmonization succeed, and where do implementation challenges remain? Register for the session

    Join the Regulatory Science Community on September 25 for Perspectives on Global Harmonization, featuring Kevin Moore and Richard L. Lew of USP.


    This session will examine current developments and practical considerations related to global harmonization, including:

      • Pharmacopeial Discussion Group harmonization activities
      • The ICH quality pipeline
      • WHO and reliance pathways
      • Bilateral and regional harmonization initiatives
      • Challenges associated with implementation across markets

    Topics raised during the session may also inform future webinars, presentations, and community activities.


    Get Involved

    The Global Harmonization & Submission Strategy Focus Area continues to welcome participants interested in international regulatory trends, harmonization efforts, and submission strategy considerations. Whether you actively follow global regulatory developments or want to learn more, we'd love to hear from you. 

    Regulatory Science - @Allison Radwick, @Mark Arnold · Global Health - @Erica Schlesinger,  @Sravan Kumar Patel


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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: Join us September 25 noon to 1pm ET for a Perspectives about Global Harmonization

    Posted 16 days ago

    Excellent and timely Webinar today! Some additional references below. Recording will be posted soon! Stay tuned!

    See you in New Orlean! Regulatory Science Community Meeting & Greet on Monday 10/26 11am-1pm at Booth 2143, sharing Solution Center with Pharmaceutical Quality and Bioanalytical Communities!

    Pharmacopeial Discussion Group & International Harmonization

    (AAPS/RSC Webinar with Dr Kevin Moore & Dr. Richard L. Lew of USP. recorded 9/15 noon) 

    This session examined current developments and practical considerations related to global harmonization, including:

      • Pharmacopeial Discussion Group harmonization activities
      • The ICH quality pipeline
      • WHO and reliance pathways
      • Bilateral and regional harmonization initiatives
      • Challenges associated with implementation across markets

    Also, welcome anyone that is interested in international regulatory trends, harmonization efforts, and submission strategy to get Involved to our Global Harmonization & Submission Strategy Focus Team of Regulatory Science Community (GHSS/RSC/AAPS), for participants. Whether you actively follow global regulatory developments or want to learn more, we'd love to hear from you. 

    More References: 

    ·       Current PDG harmonization status: Stage 4 Notices | USP

    ·       Harmonization questions for USP: Can email Richard Lew at [email protected]

    ·       AAPS Global Health Community - @Erica Schlesinger,  @Sravan Kumar Patel

    ·       AAPS Regulatory Science Community. - @Mark Arnold, @Allison Radwick @HaiAn Zheng @Bhasker Sambar

    ·       AAPS/RSC/GHSS Team: @Joleen White, Jenny Green, @Robert Falcone, @Bakuryok Tanjei, @Lisa Crandall, @Elke Stahl



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    HaiAn Zheng Ph.D.
    Department of Pharmaceutical Sciences
    Albany College of Pharmacy and Health Sciences
    [email protected]
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