European Medicines Agency’s Post

‘EU Pharma Legislation: How It Could Impact Access and Innovation' at the 1st SFEE Summit. Join top experts for an insightful discussion #SfEESummit

📣It was a great pleasure for Phase4AI-EUProject project to participate today in an online meeting organized by the European Health and Digital Executive Agency (HaDEA), which oversees the implementation of the Horizon Europe Health Cluster, as well as other EU programmes. 📝The agenda consisted of an introduction to HaDEA and to principles for good collaboration between projects and the Agency, followed by a presentation by the European Medicines Agency (EMA). Parallel break out meetings were organized for each topic after the plenary session. #healthcare, #machine_learning, #data_analytics, #data_protection, #synthetic_data, #multiparty_computation

🌍 💊 The European Health Management Association (EHMA) is proud to be a part of the #CriticalMedicinesAlliance (CMA). Established in January 2024, the #CMA unites stakeholders from EU Member States, key industries, civil society, and the scientific community to enhance the supply of critical medicines within the EU. The alliance aims to prevent and address medicine shortages, ensuring timely and equitable access to medicines for all European patients in line with the goals of the European Health Union.   As a part of the Alliance, EHMA advocate for the Health Emergency Preparedness and Response Authority (HERA) to prioritise the digitalisation and automation of medication management systems in EU hospitals. Real-time stock visibility is essential for the Critical Medicines Act, and EHMA supports a Medicines Alliance's project aiming for 90% digitalisation in EU hospitals by 2026, aligned with the #EU4Health program.   EHMA also emphasises the importance of sharing best practices from regions or hospitals that have successfully invested in digitalisation to enhance medicine stock and demand data across the EU.   ➡ Learn more about the Alliance: https://lnkd.in/ejCraq7K 📑 Read EHMA’s recommendations for hospitals' medication management pathways in our latest position paper: https://lnkd.in/ejCraq7K   Together, we are committed to a future where all European patients have reliable access to the critical medicines they need.   #HealthcareInnovation #EHMA #CriticalMedicinesAlliance #EUHealth #DigitalHealthcare #Pharmaceuticals #HealthManagement #EU4Health Laurent Muschel Stella Karavazaki Wolfgang Philipp Daphne Von Buxhoeveden Cornelius Schmaltz Olivier Girard Anne Simon European Alliance for Access to Safe Medicines

Great opportunity to hear from the FDA, European Medicines Agency, and Health Canada | Santé Canada about the latest developments on: - Novel issues in #clinicalresearch - Emerging issues regarding #pharmacokinetics, bioequivalence and bioavailability. - #pharmacovigilance compliance #clinicaltrials #clinicaldevelopment #medicines #ecd

A great promise is becoming reality: the #IDMP implementation in Europe🌐 The UNICOM final conference brings key public actors and decision makers at the same table to discuss the project's successes and what's next. 💥 Will you take part in this momentum? 🗓️ 26 April 2024 | 📌 Brussels & online | 🆓 Open attendance Register now 👉 https://bit.ly/3xpaCC5 The UNICOM - Up-scaling the global univocal identification of medicines consortium: The European Institute for Innovation Through Health Data empirica Communication and Technology Research COCIR Nictiz HL7 Europe IHE-Europe, EHTEL - Collaborating for Digital Health and Care in Europe and many others. European Medicines Agency, EU Health and Food Safety, Ministère de la Santé, Norwegian Medical Products Agency, ANSM Agence nationale de sécurité du médicament et des produits de santé

TOPICS COVERED Key updates to ICH E6(R3) The use of technology in clinical trials Updates for trials incorporating decentralized clinical trials (DCT) features ICH E6R3 data governance updates Risk-based approach to sponsor oversight Changes in clinical trial activities, inspections, and remote regulatory assessments/ remote inspections Policy/guidance updates Clinical and bioanalytical challenges in bioequivalence studies Updates in guidance, polices, and initiatives by each agency FDA RESOURCES https://lnkd.in/epDVu24X https://lnkd.in/eaQJcgnF https://lnkd.in/eMED8kKA https://lnkd.in/ekVKE-6n https://lnkd.in/eebj3f3z

Are you looking to stay ahead of the curve in Good Clinical Practice (#GCP) and #Pharmacovigilance #compliance? Then don't miss the Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium! This virtual event, taking place on February 13-15, 2024, will bring together leading regulatory experts from the US, UK, and Canada to discuss the latest developments in GCP and Pharmacovigilance compliance. Here's what you can expect: * In-depth discussions on key topics like risk-based monitoring, data integrity, and post-marketing surveillance. * Expert insights from regulatory authorities and industry leaders. A chance to stay up-to-date on the latest regulatory requirements and best practices. Whether you're a seasoned veteran or just starting out in clinical research, this symposium is a valuable opportunity to learn, network, and grow your knowledge. Register today and join us for this important event! #FDA #MHRA #HealthCanada #GCP #Pharmacovigilance #ClinicalTrials #Symposium P.S. Share this post with your colleagues who might be interested!

Great opportunity to hear from the FDA, European Medicines Agency, and Health Canada | Santé Canada about the latest developments on: - Novel issues in #clinicalresearch - Emerging issues regarding #pharmacokinetics, bioequivalence and bioavailability. - #pharmacovigilance compliance #clinicaltrials #clinicaldevelopment #medicines #ecd

Looking forward to this upcoming MHRA-FDA-Health Canada GCP and Pharmacovigilance Compliance Symposium! Leaders from all 3 agencies will be delving into crucial topics shaping the future of clinical development. From GCP E6(R3) updates, clinical trial technology, PV compliance, decentralized trials, data governance, and more – this conference promises to be a wealth of insights. It's an excellent NO-COST virtual or in person opportunity to stay at the forefront of industry trends, connect with professionals driving innovation in the field, and earn some CEUs! If you're attending too, let's connect! 🤝 I'm planning to attend in person! #GCPConference #GCP #ClinicalTrials #ClinicalDevelopment #clinicalresearch #regulatoryaffairs #FDA #MHRA #HealthCanada #SanteCanada #goodclinicalpractice #ICHE6 #Pharmacovigilance

The European Medicines Agency (EMA) is harnessing Real-World Data (RWD) to revolutionize regulatory decision-making. 🩺📊 The Data Analysis and Real World Interrogation Network (DARWIN EU) plays a key role, onboarding 20 data partners by end of 2023 and planning for 60-70 studies in 2024. The goal? Up to 150 studies by 2025. Link to the study in the comments below 👇 RWD bridges knowledge gaps, offering insights into drug utilization, disease prevalence, and treatment patterns. This independent, transparent evidence generation enables faster, more informed decisions. #RealWorldData #PharmaResearch EMA's access to diverse data sources ensures tailored, robust analyses. From hospital records to insurance data, the depth and breadth of RWD drive efficient, comprehensive studies. The potential for repeated, timely studies means always having the latest insights at our fingertips. In comparison, the US regulatory framework is evolving, but the integration of RWD into regulatory decision-making lags behind Europe. The EMA's proactive approach and structured pathways, like DARWIN EU, highlight the potential for the US to enhance its own RWD utilization to streamline processes and improve patient outcomes. This initiative underscores the value of RWD in validating evidence, providing new perspectives, and supporting public health decisions. It's a testament to how data can transform regulatory landscapes. 👉 Follow xCures Read our LinkedIn Newsletter: https://lnkd.in/dnNJV2ti https://xcures.com/ 👀