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Don't miss the May 9th Panel Discussion: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends

  • 1.  Don't miss the May 9th Panel Discussion: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends

    Community Leadership
    Posted 05-08-2024 00:19

    Dear All, Friendly reminder to join our May 9th event. Bring your questions and thoughts. Zoom link below.

    "Panel Discussion: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends"

    DATE:  09 May 2024

    12:00 pm to 12:50 pm PST
    2:00 pm to 2:50 pm CST
    3:00 pm to 3:50 pm EST

    Please join us for an engaging panel discussion titled: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends.

    The discussion will be driven by questions from community members and the audience on each of the following topics on in-use stability and panelists will share their experience and views:

    ·        Inputs into In-Use Study Design

    ·        Methods and Specifications

    ·        Study Timing and Sample Selection

    ·        Sample Handling and Exposure

    We hope you will be able to join us in the discussion on 9th May, as we participate in knowledge sharing and professional development.

    This session was organized by the AAPS Stability Community Leadership Team: Sherilyn Campie, Kim HuynhBa, Vinaya Kapoor, Lori McCaig, Dan Willingmyre and Kayla Woodlief.

    Panelists

    Vinaya Kapoor, PhD, Sr Director, Head of Regulatory Affairs CMC, Arcus Biosciences

    Danielle Leiske, PhD, Director, Pharmaceutical Development, AbCellera

    Jing Liu, PhD, Director, Business Strategy and Operation, Pfizer

    Tony Mazzeo, PhD, Associate Scientific Director, Product Development-ASO, Stability, BMS

    Nanda Subbarao, PhD, Sr Consultant, Biologics Consulting Group 

    Sarah Weiser, MS, Sr Principal Scientist, Pfizer

    Moderators

    Sherilyn Campie, MS, Director, QC Stability, Coherus Bio Sciences 

    Kim HuynhBa, MS, Managing Director, Pharmalytik

    Dan Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology Inc.

     

    MEETING INFORMATION

    No registration is necessary.

    The discussion will begin promptly at 12:00 pm PST/2:00 pm CST/3:00 pm EST.

    Link for Joining Virtual Panel Discussion

    Join Zoom Meeting

    https://temple.zoom.us/j/91403480752

    Meeting ID: 914 0348 0752

    One tap mobile

    +13092053325,,91403480752# US

    +13126266799,,91403480752# US (Chicago)



    ------------------------------
    Vinaya Kapoor, PhD
    Head, Regulatory Affairs CMC
    ------------------------------


  • 2.  RE: Don't miss the May 9th Panel Discussion: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends

    Community Leadership
    Posted 05-11-2024 19:29

    Thanks for organizing this discussion on In-Use stability. It was very well done. 
    I missed part of the discussion. If the session was recorded, or you plan to provide notes, that will be great.



    ------------------------------
    Tapan Das, Ph.D., FAAPS


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

    Original Message


  • 3.  RE: Don't miss the May 9th Panel Discussion: In-Use Stability: Current Practices, Emerging Requirements, Expectations, Challenges and Trends

    Community Leadership
    Posted 05-12-2024 01:23

    Hi @Tapan Das, 

    Thanks for your kind message. It is very valuable to have your positive feedback as it helps us plan future such sessions accordingly. Greatly appreciate it.

    We are writing up a summary and will share it with the community. 

    Best, Vinaya



    ------------------------------
    Vinaya Kapoor, PhD
    Head, Regulatory Affairs CMC
    ------------------------------

    Original Message