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  • March CSP community call

    The March call will focus on the revision III update to GVP XVI, following an excellent session at this week's DIA event in Brussels.

    Please see the events page for full information

    Thursday 21st at 4pm UK

    Meeting ID: 952 2731 2509

    Passcode: 760806

  • Join us on Tuesday, March 12th for our monthly conference call

    ALERT:  Log in information for the calls has been updated and a password is required!

    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!

  • DIA Regulatory Policy and Intel

    DIA Regulatory Affairs Community: 

    Join us for the DIA Regulatory Policy and Intelligence meeting on March 19th at 12pm ET to hear Theresa Mullins (FDA) discuss Greater Regulatory Harmonization and Reliance Efforts.  

    Dial-in Instructions:

    Topic: Regulatory Policy and Intel Community Meeting Time: Mar 19, 2024 12:00 PM  Join Zoom Meeting https://diaglobal.zoom.us/j/92507126770?pwd=YmlEdWk4WUtkWjZwUVlCNndlK3lYUT09   Meeting ID: 925 0712 6770 Passcode: 847006

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