Greetings All,
Please see the following message from Annette Medina regarding the monthly discussions in the DP Handling Working Group. Hope some of you will be able to attend. Please reach out to her for a gotomeeting invitation.
Please find attached the summary notes from our group discussion. I emailed you all with a bimonthly meeting series to restart the WG. Our first presentation is being led Reza and this will take place on April 21. See below for the additional topics that were presented for future discussion and please email me and Sreedhara with a date on when you can present (note that we can include more than one topic per date).
Then, please let me and Sreedhara know if you are interested in serving as a group co-lead between May and October of this year.
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Topic
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Presenter(s) / Facilitator(s)
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Date
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Comparison of manual compounding and robotic compounding
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Reza Nejadnik and Mirjam Crul
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April 24, 2023
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Update on IMI RealHOPE consortium – insight on educational materials and transportation strategies
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Jonas and Annette (or Stan)
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Strategies for dilution and administration of very low concentration biologics
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Brian Murphy to facilitate group discussion
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Simulated in-use transportation strategies
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Isabella to facilitate group discussion
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Updates from cross-company consortia such as IQ CSTD Task Force, IQ In Use Microbial Stability, and IQ In-Use Physicochemical
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Isabella and Annette (or Stan)
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User centricity during in use handling (recent article and general discussion)
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Twinkle to facilitate group discussion
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Novel modalities – cell therapy, ADC's, etc.
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TBD, could invite colleagues from CGT working group and/or have group discussions
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Novel in use DP preparation techniques
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Component vendors?
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Regulatory strategy for 32p26, how much is needed?
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Tapan to facilitate group discussion?
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Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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