Hi everyone,
We had a very productive 30-minute discussion at tend of May on the question: "Where should the Regulatory Sciences Community focus its energy?" Thank you for the great responses before, during, and after the meeting!
Here's a quick update on where we're headed. We've organized our work into five scientific focus areas:
• AI, Digital Twins & Model-Informed Regulatory Science (our flagship area)
• Global Harmonization & Submission Strategy
• CMC Regulatory Science & Lifecycle
• Impurities, Safety & Toxicological Risk
• Preclinical & Clinical Regulatory Science
These give us a clear structure for programming, writing, and collaboration with our fellow communities. For more detail, see the attached map.
We're excited to announce @Bhasker Sambar as our community secretary. Bhasker will keep the community organized and moving.
Over the next few weeks, @HaiAn Zheng, @Bhasker Sambar and I will be reaching out individually to confirm topic leaders and to build out the writing and programming activity teams for each focus area. If one of these areas is in your wheelhouse - or you'd like it to be - this is the moment to raise your hand.
Our next meeting is Friday, June 26, 12:00–1:00 pm ET (connection details to follow).
Thanks for being part of this - more soon.
Allison, HaiAn and Bhasker
------------------------------
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.
------------------------------