WCG’s Post

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

sIRB mandate from FDA is on the horizon. Are you ready? Join us for an exclusive webinar on developing a robust sIRB action plan to streamline your research processes. Learn valuable insights from industry experts - Joshua Fedewa and Adam J McClintock and enhance your compliance strategies. #ResearchCompliance #Webinar #Advarra #sIRB #FDA #clinicalresearch #clinicaltrials #trials

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

Get ahead of the FDA’s impending single Institutional Review Board (sIRB) mandate and optimize your clinical trials with WCG! Our webinar, "Maximizing the Power of Central IRBs Prior to the FDA's sIRB Mandate," is NOW AVAILABLE ON DEMAND! Unlock insights on how to best prepare for the sIRB mandate and how to identify the right sites to ensure the success of your clinical trials. Access now at https://lnkd.in/gJhSYN9q #WCG #webinar #sIRB #sIRBmandate #IRB #siteselection #singleinstitutionareviewboard

Get ahead of the FDA’s impending single Institutional Review Board (sIRB) mandate and optimize your clinical trials with WCG! Access our webinar, "Maximizing the Power of Central IRBs Prior to the FDA's sIRB Mandate," NOW AVAILABLE ON DEMAND! Tune into industry experts as they dive into: 🔍An overview of the impending sIRB mandate. ⚙Strategies for streamlining clinical trial processes to meet the new requirements. 🏢The critical role of site selection, including best practices for identifying and preparing sites. ✅ Proactive steps to ensure a smooth transition to an sIRB process. Watch now to prepare your studies and processes at https://lnkd.in/gJhSYN9q #WCG #webinar #sIRB #sIRBmandate #IRB #siteselection

🚨 New Variation Regulation: Are You Prepared? 🚨 Starting January 1, 2025, the amended Variations Regulation (EU) 2024/1701 will come into effect, introducing streamlined processes for post-authorisation changes to marketing authorisations. This marks a significant step forward in simplifying the lifecycle management of medicinal products for human use. 🔑 What’s changing? • Updated Article 5 procedures. • Annual updates for Type IA minor variations. • New rules for grouping and super-grouping Type IA variations. • Mandatory worksharing procedures to improve efficiency. 🛠️ What should you do now? During the transition period, marketing authorisation holders (MAHs) must continue following the current guidelines until the updated version is published. Take this time to review your systems, documentation, and processes to ensure a seamless transition. 📢 Stay up to date by checking the CMDh and EMA websites regularly : https://lnkd.in/eeEF9RJi #PharmaRegulations #EUCompliance #Medicines #MarketingAuthorisation #Healthcare

Site-specific ICF language can delay SSU by 2-4 weeks....which will be an even bigger problem when FDA finalizes its sIRB final rule. But there's a way to avoid those delays entirely! Join our Dec 10 webinar to find out:

Site-specific ICF language can delay SSU by 2-4 weeks....which will be an even bigger problem when FDA finalizes its sIRB final rule. But there's a way to avoid those delays entirely! Join our Dec 10 webinar to find out:

Are you looking for Regulatory Updates from US FDA and Health Canada? Every month, our Regulatory Competence Center experts curate a comprehensive newsletter, bringing you all the essential regulatory updates from the US FDA and Health Canada. This free newsletter ensures you can… : • Save time thanks to expertly summarized updates • Stay informed on crucial regulatory developments • Adapt your regulatory strategy to any changes in advance Subscribe now and keep your regulatory knowledge sharp: https://lnkd.in/dgiz_fe4 #EXTEDO #RegulatoryUpdates #FDA #HealthCanada #Newsletter

The European Directorate for the Quality of Medicines (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance. This document clarifies the conditions for acceptability of this type of dossiers and describes the documentation to be provided. Source: https://lnkd.in/dtsC6UCn #EDQM #CEP #Europe #sterile #dossier #aseptic