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Presentation Material Available for AAPS CMC Community Virtual Panel Discussion on Regulatory Collaboration: Project Orbis for Chemistry Manufacturing and Controls

  • 1.  Presentation Material Available for AAPS CMC Community Virtual Panel Discussion on Regulatory Collaboration: Project Orbis for Chemistry Manufacturing and Controls

    Posted 09-23-2022 18:17
    Thank you for participating in our virtual panel discussion on January 21, 2022 on Regulatory Collaboration: Project Orbis for Chemistry Manufacturing and Controls.

    The meeting presentation is now posted on the CMC Community's Library. 
    We would like to thank our expert panel consisting of Ajay Acharya (Merck), Tao Li (Seagen), Sherita McLamore (FDA) and Rakhi Shah (FDA) for contributing their expertise and knowledge to the discussions. A big thanks also to the organizing team consisting of James Bernstein (Live Oak Pharmaceutical Consulting), Nina Cauchon (Amgen), Kim Huynh-Ba (Pharmalytik), Andrea Schirmer (Boehringer Ingelheim), David Schwinke (AbbVie), Helen Strickland (GSK), Kin Tang (Genentech), and Rita Algorri (Amgen).

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    Rita Algorri, PhD
    Regulatory Affairs Manager
    Amgen
    Thousand Oaks CA
    [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: Presentation Material Available for AAPS CMC Community Virtual Panel Discussion on Regulatory Collaboration: Project Orbis for Chemistry Manufacturing and Controls

    Community Leadership
    Posted 09-23-2022 20:59
    Thank you for posting it, Rita. I appreciate your efforts to lead this session successfully.

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    Kim HuynhBa, MS, PMP, FAAPS
    PHARMALYTIK Consulting
    Executive Director
    [email protected]
    Newark DE
    USA
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    Original Message