Veristat’s Post

The European Commission launched a public consultation on the cooperation with the European Medicines Agency under the Health Technology Assessment (HTA) Regulation. The proposed Implementing Act includes measures on: 📍Information-sharing 📍Joint clinical assessment/scientific consultations for devices and drugs 📍Patient identification and expert involvement in joint assessments 📍The protection of confidential information The public consultation will end on 24 July 2024 The Act is the third of six Implementing Acts undergoing public reviews > https://hubs.li/Q02DRlmV0 #HealthTech #RegulatoryFramework

The Health and International Relations Monitor project, supported by the Health Foundation, has released a new report on the future of health after Brexit. The report highlights that global medicine shortages are being felt particularly acutely in the UK, and the country's reliance on migration as a source of health and social care staff is intensifying. As the relationship with Europe continues to evolve, it is crucial for the UK to evaluate the impact on the delivery of health and care services. The full report is below. #pharma #medtech #devices

The new Health Technology Assessment Regulation (HTAR) will be gradually enforced from 2025. It involves Joint Clinical Assessment (JCA) for evaluating effectiveness and safety, and Joint Scientific Consultation (JSC) to facilitate scientific collaboration. The Joint Clinical Assessment (JCA) introduces a standardized approach to health technology evaluation. Unlike previous fragmented assessment methods, JCA harmonizes the evaluation process across European Union member states, ensuring consistency and efficiency. By providing evidence-based insights into the clinical relative effectiveness and safety of medicinal products and medical devices, JCA empowers stakeholders to make informed decisions, leading to improved patient care and optimized healthcare resource allocation. Learn more about the specifics of this new assessment procedure in this comprehensive white paper written by Dr Sigrid Klaar, Medical Advisor and NDA Advisory Board Member. #HTAR #JCA #HTA #regulatoryaffaris #marketaccess #drugapproval

📢 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

Learn about the impact that ICH E6(R3) may have at your organization

In this Fourth Branch episode, experts Michael Cannon and Christina Sandefur discuss the implications of the decisions made by the FDA and the consequences of unsafe access to drugs. Listen in as they consider the role of agencies in health spaces across America: https://lnkd.in/ewtGB4ZD

📣 NEWS IVDR & EUDAMED Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply >> https://lnkd.in/evGNmjt5 The Commission is proposing to extend the transition periods to give manufacturers and NBs more time to complete the necessary conformity assessment procedures. ❗❗ The extension will be subject to conditions and therefore safeguard the high level of requirements set out by the legislation and protect public health. The Proposal will now be put forward to the European Parliament and Council for adoption. See the Commission proposal >> https://lnkd.in/dxkr4UEb See the Q&A document >> https://lnkd.in/epA9QaNK Download the factsheet >> https://lnkd.in/ehR3DxPb #IVDR #IVDs #MedicalDevices #InVitroMedicalDevices #InVitroDiagnostics #IVDcertification #EUregulation #EUcommission #Eudamed #MedTech #IVDregulation

Rita Hattemer-Apostel, a well-known expert on clinical regulations, discusses the impact of ICH E6(R3) on clinical technology, as well as the most common compliance issues related to #clinicaltechnology on August 17 at CTIO. https://bit.ly/3OBo8sh. Momentum Events #clinicaltech #clinicaltrials #clinicalresearch #clinical #technologyinnovation #technologyintegration

The July/August edition of #RegulatoryRapporteur is out now. This month, we focus on #equalaccess to #medicines and #regulatoryframeworks around the globe, from the #regulatory ecosystem in #Africannations to #EU #healthtechnologyassessments. Thank you to our contributors to this issue: Joan Boren, Vinetta Brew MA BSocSc (Hons), Chimwemwe Chamdimba, Maria Fernandez, Patrick Fivey, Hilary Gray, Simon Hoffman, Ian Hudson, Andrew Jackson, Lena Jansson, Suzanne Jenkins, Roy Milner, David Mukanga, Margareth Ndoomonda-Signoda, Sabina Patel, and Marta Thomsen. Read #RegulatoryRapporteur online now 👉 https://lnkd.in/eDDeswu6 #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members.

The EU regulatory landscape for medicine development is complex, but our session from DIA Europe 2024 on ‘Complexity: Interplay and Interface of Different Legislations’ can help! This session explores the challenges and opportunities that arise when various regulations intersect in the development and manufacturing of medicines. Join a diverse panel of experts including medicine developers, policymakers, regulators, patients, and academics as they discuss: ◾ The impact of overlapping regulations in R&D and manufacturing. ◾ Practical strategies to navigate these complexities. ◾ Guiding principles for effective policy development. Don't miss this valuable resource! Watch the session now and gain insights to navigate the evolving regulatory environment: https://bit.ly/46iCK7n. For more information and to stay updated on DIA Europe 2025, visit our website: https://bit.ly/3LmbH19. #DIAEurope #HealthcarePolicy #Learning #RegulatoryAffairs