European Medicines Agency’s Post

Great initiative for the #regulatoryaffairs community! Launching in 2025, the European Platform for Regulatory Science Research will bring together academia and regulators as well as other relevant stakeholders to accelerate impactful, collaborative regulatory science research solutions for global progress. The Platform will launch in 2025 with a one-year pilot phase. The steering group members are expected to meet (virtually and on some occasions in person) every 8 weeks (i.e. six times a year) and provide strategic and operational advice. Calls for expression 👉as nominated member of the steering group – deadline of 24 January 2025 👉as platform participant – submission encouraged by 24 January 2025 with the call remaining open over the course of 2025 A second call for expression of interest for patients, healthcare professionals, industry, and health technology assessment bodies to participate will open later in 2025. Read more: https://lnkd.in/dRVk6Rxu

EMA's launching a platform for regulatory science research. A call for academia is now open with calls later this year for patients, industry, healthcare and technology representatives. #EMA #RegulatoryScience

🎊 In 2025, European Medicines Agency and HMA are launching the new European Platform for Regulatory Science Research. The Platform will bring together academia and regulators as well as other stakeholders with the aim of accelerating impactful, collaborative regulatory science research solutions. 📢 The call for expression of interest for researchers to participate is now open There are two ways to join the initiative 1. as nominated member of the steering group - deadline of 24 Jan 2025 2. as platform participant - submission encouraged by 24 Jan 2025 with the call remaining open over the course of 2025 More information about the Platform for Regulatory Science Research including details on how to join, can be found here: https://lnkd.in/eBqv56i9 #regulatoryscience

🌟 Transform the Future of Regulatory Science in 2025! The European Medicines Agency (EMA) and the Heads of Medicines Agencies are launching an exciting European platform for regulatory science and research this year. This groundbreaking initiative will unite academia, regulators, and other stakeholders to accelerate solutions in regulatory science. 🌐💡 Looking to digitize your lab workflows and connect to cutting-edge research platforms? Explore BIOVIA ELN & LIMS, designed to enhance collaboration, streamline data management, and support compliance with regulatory standards in scientific research: https://lnkd.in/dt95Gnip Let’s shape the future of regulatory science together! 🚀✨ #RegulatoryScience #Research #Academia #Innovation #Collaboration #DigitalLab #BIOVIA #TECHNIA #SmarterProductsFaster

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

📢 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

Read our recent panel discussion on clinical trials, which covers everything from increasing diversity in clinical trials to understanding and working with complex regulations. https://lnkd.in/eWrmKUhH Our panelists share insights and experience with clinical trials around the world and explain how the new regulations will benefit clinical trials and their results. #LifeSciences #ClinicalTrials #LatinAmerica #RegulatoryAffairs

Discover how TruMinds Clinical can be your trusted partner in clinical research organization services. From streamlined study management to expert regulatory compliance, our dedicated team and innovative solutions ensure quality outcomes for your research projects. Join us in driving impactful research and elevating the standards of clinical research together! 💼💡 #TruMindsClinical #ClinicalResearch #OrganizationServices #ClinicalTrails #CROServices

📌 NEWS - Navigating the New Regulation on Health Technology Assessment (HTA) ▶ As of January 12th, 2025, Regulation (EU) 2021/2282 on health technology assessment has come into effect! This landmark #legislation enhances #cooperation among #EUMemberStates, creating a unified approach to evaluating #healthtechnologies, including medicines, #medicaldevices, and other interventions. ▶ The #HTA Regulation establishes a Joint Clinical Assessment process, focusing on the #clinical aspects of #newtechnologies. By fostering collaboration across the EU, it aims to eliminate duplication of efforts, optimize resources, and ensure faster access to innovative healthcare solutions for patients. To sum up: ✔️ Pool resources at the #EU level by introducing a single submission file for #JointClinicalAssessments. ✔️ Establish faster #procedures, enabling quicker access to essential #medicines for patients. ✔️ Keep #patients at the center, with their input being consulted throughout the process. ▶ As a first step, these new rules apply to new #cancermedicines and #advancedtherapymedicinalproducts. By 2028, they will extend to #orphanmedicines and eventually cover all new medicinal products.

Outsourcing in Clinical Trials conference on May 7-8. As co-sponsors, we are eager to engage in meaningful discussions on the forefront of clinical trials innovation – as always with the patient in our minds. Looking forward to meeting our industry peers to exchange ideas and insights that drive patient-centric solutions forward. Get ready to Connect, Barcelona! #dtc #decentralized clinical trial #Remote Patient Monitoring #Clinical Research #Digital Health Solutions #Regulatory Compliance #Democratizing clinical research