DIA’s Post

📢 The European Commission has released the draft for the third Implementation Act (IA) under the EU Health Technology Assessment (HTA). This draft outlines procedural rules for the cooperation between the Member State Coordination Group on HTA, the European Medicines Agency (EMA), and other relevant expert panels. 𝐊𝐞𝐲 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: ‣ Coordination and information exchange between the HTA Secretariat and EMA ‣ Establishing consistency and timelines for joint clinical assessments and scientific consultations ‣ Clear guidelines for the identification and involvement of expert panels and individual experts ‣ Robust measures for protecting confidential information throughout the process The IA ensures a streamlined, transparent, and secure evaluation process for medicinal products and medical devices across the EU, facilitating better healthcare outcomes. 📅 The consultation period is open until July 24th. Read more and participate here: 🔗 https://lnkd.in/gmAnkey4 ✅ Please reach out to Kate Noble to understand the implications of this update and how we can assist you in navigating these changes. #EUHTA #HTAregulation #jointclinicalassessment #jca #healthcare #marketaccess #regulationchanges

⬇ Download our quarterly update: https://lnkd.in/eTWddKXg In our latest global Health and Life Sciences newsletter, we roundup key legal developments with governments worldwide prioritising regulatory reforms in healthcare. This edition includes updates from across Europe including changes to the medical devices system in Portugal and various reforms to the food and supplement regulatory regime in Poland and the Czech Republic. We also report on various updates on clinical trial investigations as well as ongoing policy debates on AI in the UK #LifeSciences #Regulatory #ArtificialIntelligence

With the new EU Health Technology Assessment regulations scheduled to take effect exactly one year from today (on January 12, 2025), we have a new whitepaper to guide drug developing companies. This whitepaper written by Dr Sigrid Klaar, Medical Advisor & NDA Advisory Board Member, explores the Joint Scientific Consultation. It aims to address company questions on clinical study design and other evidence generation issues from a HTA and payer perspective. The paper offers useful advice for stakeholders on making the most of this opportunity to engage with HTA agencies under the new rules. Click the link below to download the whitepaper. https://lnkd.in/dwWjacR6 #HTA #JSC #DrugAccess #EMA

Today, 21 June 2024, the EMA published guidance to applicants/health technology developers on how to declare in the EMA Letter of Intent (via the Pre-submission request form) whether their application falls under the scope of the Health Technology Assessment Regulation ((EU) 2021/2282 Article 7) and, therefore, is subject to JCA. Adicionally, the Member State Coordination Group on Health Technology Assessment published a document entitled “Scientific specifications of medicinal products subject to joint clinical assessments” to support identification of products subject to JCA from 2025. This launch kicks-off a new era of collaboration between regulators and HTA bodies under the new European legal framework. Are you ready?

I will be speaking at #MedDevDay conference in Copenhagen about „pragmatic #postmarketsurveillance“ under EU MDR. Looking forward to discuss the latest developments in #medtech regulatory landscape and excited to listen to great presentations and even more so, have interactive and lively discussions with the audience! LS Academy #postmarketsurveillance #vigilance #eumdr

Are you up-to-date with EU Clinical Trials Regulation? Download ClinChoice's free whitepaper to learn about significant changes under regulation, streamlined reporting, and more! Visit ClinChoice's resource library: https://hubs.la/Q02dgq_F0 #ClinicalTrialsRegulation #RegulatoryAffairs #EUCTR

⭐ Regulatory Update ⭐ EMA/CHMP/150527/2024: Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence. This Draft document provides guidance on the use of real-world data in non-interventional studies to generate real-world evidence and is open for public consultation until 31 August. You can download the document here: https://buff.ly/3VJUsNd #clinical #clinicalresearch #clinicaltrials

⭐ Regulatory Update ⭐ EMA/CHMP/150527/2024: Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence. This Draft document provides guidance on the use of real-world data in non-interventional studies to generate real-world evidence and is open for public consultation until 31 August. You can download the document here: https://buff.ly/3VJUsNd #clinical #clinicalresearch #clinicaltrials

🌏 Exploring the Benefits of Conducting Clinical Trials in Asia-Pacific Regions 🏥 Considering conducting clinical trials? Discover why Asia-Pacific regions are the optimal choice! From diverse patient populations to streamlined regulatory processes, Asia-Pacific offers unparalleled advantages for advancing medical research. Learn more in our latest article! #ClinicalTrials #AsiaPacific #MedicalResearch 👉 Contact @Credevo for conducting your clinical trials in the Asia-Pacific region! https://buff.ly/3V17RPg

Thank you to Sara Tylosky, Anna Eisenberg, and Samantha Geraci-Yee for an amazing webinar today on diversity in clinical trials! There are several barriers that limit the enrollment of minorities in clinical studies (language barriers, lack of awareness, mistrust, etc.), yet it is crucial that trial participants adequately represent the patient population. It's certainly a complex balance, but we heard some great solutions today, such as: -Strategic social media outreach via highly used platforms -Utilizing a trusted translation services company that has vast experience in the life sciences space (such as DTS Language Services or Morningside!) -Implementing decentralized clinical trial (DCT) strategies and therefore improving accessibility