Join us on Friday, August 28, from 12:00 to 1:00 PM ET for a CMC and Global Harmonization Discussion.
Agenda
1. Welcome and community updates - 5 minutes
2. Overview: CMC regulatory science - 10 minutes
What the discipline covers and which threads are live in 2026 (Q3E, the Q1 revision, Q6(R1), nitrosamines, Q12 adoption, AI and advanced manufacturing).
3. Overview: global harmonization regulatory science - 10 minutes
4. Open discussion and your input - 30 minutes
What is on your mind and what would you like to hear at our next community meeting about global harmonization on September 25. U.S. Pharmacopeia will present and want you to shape the conversation. Come prepared to answer two questions: which harmonization problem costs your team the most time, and which market keeps surprising you with a requirement you did not expect.
5. Next steps and close - 5 minutes
These are overviews rather than deep dives. The point is to build a shared map and find out which topics this community wants to take further as full sessions or proposals.
Register here: https://science360.aaps.org/science360/?menu=24&browseby=9&sortby=1&trend=27606#!*menu=24*browseby=9*sortby=1*trend=27606*filter=231
If you cannot attend, add your thoughts to the two questions above to this thread or reach out to @HaiAn Zheng, @Bhasker Sambar or @Allison Radwick.
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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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