James Riddle’s Post

Last Chance! Register today to talk with Adam, myself, and many others about sIRB and the upcoming FDA sIRB mandate. Explore the importance of a well-defined sIRB action plan in our upcoming webinar. Stay ahead of the curve and ensure your research operations are compliant and efficient. Reserve your seat today! #ComplianceWebinar #ResearchExcellence

The FDA has released two Notices of Proposed Rulemaking (NPRMs) to align its IRB and informed consent regulations with the 2018 Common Rule revisions. One NPRM proposes mandating the use of a single IRB (sIRB) for multi-site research under FDA oversight, which would impact institutions currently using local IRBs. Today's sponsored blog from WCG discusses how institutions can prepare for compliance with these potential changes. Read more > https://bit.ly/3U1rkzQ #ClinicalResearch #FDA #IRB #sIRB #CommonRule #ResearchCompliance #WCG #SponsoredContent

Dive into the intricacies of the FDA's proposed Single Institutional Review Board (sIRB) Mandate with crucial insights with industry experts David Forster, Sandy Smith, RN, MSN, AOCN, and Donna Snyder in our upcoming webinar! Our webinar "Revisiting the FDA's Proposed Single IRB Mandate: Navigating Changes and Aligning for Success” will share crucial insights and updates to ensure your organization remains compliant and efficient in multi-site clinical trials, covering:  💡A recap of the 2022 NPRMs  💡The latest developments surrounding the FDA's proposed sIRB mandate  💡Demystifying the FDA  ⭐⭐⭐And more!   Register now to secure your spot and stay ahead in the ever-evolving landscape of clinical research compliance at https://lnkd.in/ec6vAYVh  #FDA #clinicaltrial #IRB #sIRB #ethicalreview #clinicalcompliance #webinar #WCG 

🔔NOW AVAILABLE ON-DEMAND🔔 💻Webinar: Maximizing the Power of Central IRBs Prior to the FDA's sIRB Mandate 👀Watch now to get ahead of the impending single Institutional Review Board (sIRB) mandate and understand the critical role of site selection to optimize your clinical trials! ▶ https://lnkd.in/eJWbjUft #WCG #webinar #sIRB #sIRBmandate #IRB #siteselection

Get ahead of the impending single Institutional Review Board (sIRB) mandate and optimize your clinical trials with WCG! Join us for our upcoming webinar, "Maximizing the Power of Central IRBs Prior to the FDA's sIRB Mandate." Join industry experts Matthew Staves and Crissy MacDonald, PhD as they share insights on how to best prepare for the sIRB mandate and the critical role of site selection. Enhance your understanding of identifying the right sites and ensure the success of your clinical trials! Register now at https://lnkd.in/ec-8XMEG #WCG #webinar #sIRB #sIRBmandate #FDA #IRB #ethicalreview

📅 As the critical June 22, 2024, deadline approaches, it's essential for Annex XVI manufacturers to stay informed about the transitional provisions.   🔍 To help you navigate these complex regulations, we've developed a comprehensive flowchart.    🛠️ Key Deadline Alert for manufacturers intending to perform a clinical trial: by June 22, 2024, sponsors should receive confirmation from the EU Member State regarding their clinical trial authorization request to continue placing their products on the EU market    For more detailed information on the deadlines and requirements, visit: MDlaw: https://lnkd.in/eiNUEi48   Stay compliant and ensure your products meet the new regulatory standards!   #MedicalDevices #AnnexXVI #RegulatoryCompliance #ClinicalTrials #MDR #ObelisGroup #MDlaw

Save the date for FDA's upcoming MSI Informational Day! Mark your calendar for September 18!

🎉 Join Us for the FDA PreSTAR Tutorial Kick-off! 🎉 🗓 Date: October 31, 2024 ⏰ Time: 10:30 a.m. ET Get ready to dive into the essentials of FDA PreSTAR with our upcoming tutorial! We’ll walk you through everything you need to know to navigate this powerful tool: ✨ Topics Covered: -What is FDA PreSTAR? – An Introduction -FDA Guidance and FDA CCP -Latest Version (now 1.1) with Color-coded Key -FAQ & Version History -Application/Submission Type -Cover Letters & Letters of Reference -Applicant, Primary Correspondent & Consultant Information -Pre-Submission Correspondence & Previous Regulator Interaction -Recognized Consensus Standards 📌 Don’t miss out on this chance to deepen your understanding! Register here ➡️ https://lnkd.in/eipNh3-q #FDA #PreSTAR #Webinar #MedicalRegulations #RegulatoryCompliance #Healthcare

FDA issued a draft guidance, Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway. This draft guidance, when finalized, will describe FDA’s interpretation of the term “underway” and policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to an accelerated approval action. Check out the guidance or read it below: https://lnkd.in/gZwVzyfT

The Accelerated Approval pathway has become more stringent, and Sponsors need to ensure they are preparing early and communicating effectively with all stakeholders, particularly FDA, about the clinical meaningfulness of the treatment *and* plans for a confirmatory trial. By the End-of-Phase 2 meeting with the Agency, the Applicant should ensure agreement on study design, so that by the time AA is granted, the trial is truly "underway" and benchmarks/readout will be met. See below for draft guidance. Comments are due by March 10, 2025! #regulatory #drugapproval #communications #fda #confirmatorytrial