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Our March CTD Community call will feature an open discussion on timely transparency topics you won't want to miss. We'll start by discussing the FDA's response to the citizen's petition filed by Universities Allied for Essential Medicines North America (UAEM). The petition calls for increased enforcement of results reporting, guidance on FDA enforcement priorities, and a public dashboard of Preliminary Notices of Noncompliance.
Next, we'll address the initial challenges sponsors are facing with the new Catalogue of RWD studies that replaced the EU PAS/ENCePP registry. This is an opportunity to share experiences and collaborate on solutions.
Finally, we'll delve into the challenges of identifying which regulations apply to combination drug/device products in Europe. This is a complex area where clarity is needed.
This call is your chance to stay informed on evolving compliance, real-world evidence, and regulatory issues while working together to navigate the changing landscape. I look forward to a collaborative discussion. Don't miss out on these important topics.
Date: Tuesday, March 12th, 2024 at 10am EST
Join Zoom Meeting
https://diaglobal.zoom.us/j/94448328818?pwd=NnI1UFQrSWJLOTU4RzFIRlRCbnZYZz09
Meeting ID: 944 4832 8818
Passcode: 224003
Have a great week!