WCG’s Post

Available now! The 2024 Avoca State of the Industry Report – Anticipating ICH E6 (R3): Awareness, Impact & Preparedness. For more than 20 years, Avoca, a WCG company, has surveyed the industry on key trends affecting clinical development to provide insights that can strengthen relationships and enhance R&D quality and productivity. This year’s research is focused on potential changes in regulatory guidance under ICH E6 (R3) to examine current awareness and perceived impacts – both positive and negative – among sponsors, providers, and site personnel to navigate the path forward. Understand the multi-stakeholder effects of upcoming guidance changes and the preparations involved to set up your organization for success. Download the report: https://lnkd.in/e7aC6NMe Avoca, A WCG Company #WCG #ClinicalTrials #ClinicalResearch #Report #ICHE6R3 

Snapshot from Sonja S.' presentation at COG Europe 2023. Assessing the pros and cons of #sdv and #rbm in #clinicaltrials Review below!

Getting ready for 2025: Joint Clinical Assessment by HTAs at European level will become reality soon and the interface with the regulatory processes are being established. It was a true pleasure to co-chair with Niklas Hedberg today’s HTA Townhall at DIA Europe in Brussels and to discuss with the various actors these exciting and ground-breaking developments. The commitment by all in the panel - #policy makers, #regulatory and market #access colleagues from industry, #HTA colleagues, #regulators and #patient representatives - is clearly there: we need to collectively establish the most suitable practices for this interface. Asking the (mainly industry) audience for their priorities, bridging internal processes and looking at evidence needs also in the global context were highest ranking. The clock is ticking so planning (eg portfolio reviews), internal alignment as well as using opportunities to discuss evidence plans (such as the interim framework for parallel EMA / HTA body advice) were certainly take-home messages from the discussion. And Isabelle Stoeckert sharing experience with preparatory steps was certainly insightful for all participants. Thank you to the panelists and the audience for very engaging discussions!

Last week I presented at Regulatory Affairs Professionals Society (RAPS) on key considerations for PMCF Surveys! I recently recorded a webinar with the Global Regulatory Writing & Consulting (GLOBAL) team on this topic, with their additions regarding the planning stage & what to do with the data that you collect. With the MDR timeline extension, now is the perfect time to consider your PMCF strategy. PMCF surveys are one of the most cost-effective data collection tools available. #pmcf #pmcfsurveys #mdr #eumdr

Marcus Torr - Purdie Pascoe presenting at Regulatory Affairs Professionals Society (RAPS)! Have a look for Marcus' insight on the topic of key considerations for PMCF surveys!

7 days to go! Brace yourselves for an engaging discussion on Europe's position in global clinical trials. Join us and Xtalks on November 29 for a webinar dissecting the implications of CTIS and Regulation 536/2014. Save your spot! Register here: https://zurl.co/UnFn #ClinicalTrials #RegulatoryUpdates #ClinicalResearch #GCPServiceInternational #Webinar #UpcomingWebinar

This post highlights the fast track transition to the Clinical Trials Regulation. Typically, transition application reviews can be up to 60 days or 106 days with requests for information (RFI). However, pursuing an expedited review means relevant study documents not included in the minimal document set must be provided within the first substantial modification. The expedited procedure is, therefore, a useful mechanism to fast track a study's transition but careful strategic considerations are needed to ensure it is the most efficient approach. Get in touch to find out more about the best strategy: https://lnkd.in/e52AfjTZ #Clinicaltrialsregulation #LumisInternational #clinicaltrials

Manage your team's compliance with the EU CTR from our central myGCP dashboard. This important new regulation is changing the way we do clinical trials - keep your team up to date. Talk to our team about your training needs here: https://hubs.li/Q02bNgNx0 #GCPCentral #thereisabetterway #EUCTR #training

Discover how following ICH E8 R1 recommendations can significantly boost site and participant relationships, paving the way for the long-term sustainability of patient and investigator pools in clinical research. Our webinar "Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures" dives into this topic and more! WCG’s 360 Protocol Assessment™ addresses ICH E8 R1 expectations and improves clinical trial predictability by providing sponsors with an operational risk and feasibility assessment of the protocol by representing all industry stakeholders. 👀 Watch the recorded webinar here: https://lnkd.in/ehvvSehd 💡 Learn more about WCG's 360 Protocol Assessment™ here: https://lnkd.in/eiaqhUyn #webinar #research #report #clinicaltrials

📢 New version of MDCG 2021-6 - Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation has been published. This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). PLease check the full text below 👇 #TUVNordPolska