💡 Methodological experts and assessors from HTA bodies and the European Medicines Agency came together for a joint workshop title “Understanding evidence challenges, managing uncertainties and exploring potential solutions”. The hybrid workshop was hosted by NCPE - National Centre for Pharmacoeconomics in Dublin with over 150 attendees online. 💡 This is part of an ongoing series bringing together assessors and methodologists from HTA and the EMA to discuss the common challenges in relation to evidence generation. There was a unified voice across both HTA and regulatory participants on the need to improve the evidence generation pathway and a first discussion on potential approaches to move this forward. We look forward to continuing this discussion in the next webinar in early 2025! Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Norwegian Medical Products Agency KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé RIZIV-INAMI INFARMED, I.P. Health Products Regulatory Authority (HPRA) Heads of HTA Agencies Group
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Management of uncertainty is a key issue for decision makers. Understanding how to lessen it through carefully planned evidence generation is a common desire across methodologists and assessors alike. This workshop continued to explore some of the more challenging issues with a view to proposing solutions especially as we move closer to the #HTAR in January.
💡 Methodological experts and assessors from HTA bodies and the European Medicines Agency came together for a joint workshop title “Understanding evidence challenges, managing uncertainties and exploring potential solutions”. The hybrid workshop was hosted by NCPE - National Centre for Pharmacoeconomics in Dublin with over 150 attendees online. 💡 This is part of an ongoing series bringing together assessors and methodologists from HTA and the EMA to discuss the common challenges in relation to evidence generation. There was a unified voice across both HTA and regulatory participants on the need to improve the evidence generation pathway and a first discussion on potential approaches to move this forward. We look forward to continuing this discussion in the next webinar in early 2025! Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Norwegian Medical Products Agency KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé RIZIV-INAMI INFARMED, I.P. Health Products Regulatory Authority (HPRA) Heads of HTA Agencies Group
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🌍 💊 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
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📰 As part of the roll out of the EU rules on health technology assessment (Regulation 2021/2282) six implementing acts will be adopted by the European Commission to govern the framework of operation. One area which has piqued our interest is the management of conflicts of interest (COI) in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups. The implementing act was released for comment at the end of May [1] and the final implementing act is due shortly. A key element of the new Joint Clinical Assessment (JCA) is to engage patients, clinical experts and other relevant experts with expertise from a European or International perspective. [2] The European Medicines Agency (EMA) have for a number of years managed COI but in April this year a key judgement by the European Courts has challenged the existing practice [3] meaning that as part of the roll out of JCA a more stringent approach to COI will likely be adopted. With ATMPs in scope from January 2025 and Rare Disease medicines from 2028 it will be important to see how this fine balance is achieved to ensure patients and experts are able to be engaged in the JCA process. 🗣 If you would like to discuss how JCA roll-out will affect your organisation, please reach out to Kevin Asher or Esther Nzenza for an informal meeting. 1. https://lnkd.in/ekKtTCT7 2. https://lnkd.in/eEg3QQsz 3. https://lnkd.in/e3UtKKsn #hta #jca #heor #teamdecisive #rebelthinkers
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Are you attending the upcoming TOPRA Symposium? Our experts Chantal W.M. van Gils & Sigrid Klaar are set for their session: "How the New EU Regulation on Health Technology Assessment (HTA) Will Change Clinical Drug Development and Regulatory Affairs." They are ready to share their insights and answer any questions you may have. Don’t miss this opportunity to connect with them and gain valuable knowledge on this hot topic! #TopraSymposium #HTA #RegulatoryAffairs #ClinicalDevelopment
The #TOPRA #Symposium is #Europe’s premier #conference for #healthcare #regulatoryaffairs. Chantal W.M. van Gils of SSI Strategy is one of our many #expertspeakers and she will take part in our session entitled HM8 – How the new #EU regulation on Health Technology Assessment (#HTA) will change #clinical #drug development and regulatory affairs, alongside panellist Michael Berntgen of the European Medicines Agency (#EMA), Sigrid Klaar of NDA Group - an SSI Strategy Company, Carlos Langezaal (who is both the #Chair of the Human Medicines Symposium stream and the overall event in 2024) of Premier Research and Anne Willemsen of the Government of the Netherlands National Healthcare Institute. In this short video, Chantal provides more detail about session HM8 and explains why you should join us very soon in #Rotterdam between 30 September and 2 October for the latest industry insights and developments in #humanmedicines, #veterinarymedicines and #medicaldevices/ #IVDs. The theme of this year's #Symposium is 'improving #healthoutcomes through #regulatoryexcellence'. We are hosting it in partnership with the Medicines Evaluation Board (#MEB)/College ter Beoordeling van Geneesmiddelen (#CBG), the #Netherlands' national authority of #medicines and #health products. Find out more about the Symposium programme and book now 👉 www.topra.org/symposium In addition to discounted rates for #TOPRA #members, we also offer discounts for those working for #regulatory and #government #agencies, #academic institutions, #charities, #patient groups or in full-time #education, and for bulk bookings. #TOPRASym24
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Following our successful webinar, "EU HTA Regulation: What's Changing and Why It Matters," we are excited to announce the second installment of our webinar series! Join our experts Chantal W.M. van Gils and Maxwell Craig for our upcoming webinar: EU HTA Regulation Insights - Expert Strategies for Success. They will tackle real concerns and questions raised by clients and industry leaders, sharing actionable strategies to help you succeed. This webinar will: 📌Provide recent updates on the EU HTA regulation 📌Address frequently asked questions from industry professionals 📌Explore strategic considerations for clinical development and market access 📌Discuss how to optimize resources for regulatory and HTA processes 📌Share insights on preparing for potential discrepancies between regulatory and HTA evidence requirements If you have questions you'd like us to address during the webinar, please send them in advance to LetsTalk@ssistrategy.com. Register now to secure your spot! https://lnkd.in/dg5uxb_r If you missed our previous webinar, you can find the summary and recording on our website. https://lnkd.in/dz_jywfP
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Following our successful webinar, "EU HTA Regulation: What's Changing and Why It Matters," we are excited to announce the second installment of our webinar series! Join our experts Chantal W.M. van Gils and Maxwell Craig for our upcoming webinar: EU HTA Regulation Insights - Expert Strategies for Success. They will tackle real concerns and questions raised by clients and industry leaders, sharing actionable strategies to help you succeed. This webinar will: 📌Provide recent updates on the EU HTA regulation 📌Address frequently asked questions from industry professionals 📌Explore strategic considerations for clinical development and market access 📌Discuss how to optimize resources for regulatory and HTA processes 📌Share insights on preparing for potential discrepancies between regulatory and HTA evidence requirements If you have questions you'd like us to address during the webinar, please send them in advance to LetsTalk@ssistrategy.com. Register now to secure your spot! https://lnkd.in/dg5uxb_r If you missed our previous webinar, you can find the summary and recording on our website. https://lnkd.in/dz_jywfP
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On this Clinical Trials Day, our CEO and General Manager shed light on the influx of international sponsors coming to Pakistan and the remarkable advancements we've achieved. Celebrating our nation's and company's success in ensuring GCP guidelines and successfully conducting clinical trials. Here's to continued innovation and global collaboration in healthcare. #ClinicalTrialsDay #MetricsResearch #GCP #ClinicalResearch
On this International Clinical Trials Day, Metrics Research applauds all stakeholders who contribute to developing and advancing clinical trials in Pakistan. This video features our CEO, Murtaza Hussain, and General Manager, Muhammad Sharib Syed, discussing Pakistan's evolving clinical trial landscape & the role of Metrics Research in promoting clinical trials in the country, achieving successful patient-centred outcomes and transforming healthcare globally. We look forward to continued advancements through research in Pakistan with innovation & excellence. #Internationalclinicaltrialsday #Clinicaltrialsday2024 #ClinicalTrialsinPakistan #ClinicalResearchProfessionals #healthcare #medicalresearch #MetricsResearch #ContractResearchOrganization #CRO #ResearchInnovationExcellence
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🌟 We are thrilled to have hosted the first ever joint meeting of the Heads of Medicines Agencies (HMA), National Competent Authorities on Pricing and Reimbursement (NCAPR), and Heads of HTA Agencies (HAG). 🤝 Thanks to the joint efforts of the FAMHP, NIHDI, and KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé, we are bringing together high-level representatives from key institutions in the medicinal product lifecycle, to foster early dialogue and to address shared concerns. 🔍 Topics on the agenda included repurposing of medicines and tackling unmet medical needs. The participants also delved into joint procurement and negotiations, focusing on combatting AMR and improving access to innovative medical devices and diagnostics. 🏥 The meeting concluded with plenary presentations summarising the fruitful outcomes of each session, paving the way for future cooperation and advancements in healthcare. 💊 By working together, we are paving the way to improve patient access and affordability across the EU.
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Important news! The European Medicines Agency (EMA) is taking strides to enhance the clinical trials environment in the #EU. This initiative is very relevant for patients like us, as it aims to improve the framework for clinical trials, ensuring that Europe remains competitive in clinical research and ultimately facilitating quicker access to innovative treatments. By accelerating stakeholder collaboration, the EMA is paving the way for a more patient-centric and efficient clinical trials landscape. This is a significant step forward in our journey towards better #healthcare outcomes for all. We celebrate this project, we celebrate that patient groups such as European Patients' Forum and EURORDIS-Rare Diseases Europe are part of the Multi-stakeholder Platform (MSP) and continue to advocate for initiatives that prioritize patient needs and drive positive change in healthcare. #ClinicalTrials #HealthcareInnovation #PatientAdvocacy #EMA #Europe #MedicalResearch #HealthcareAccess Alpha-1 Europe Alliance asbl
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On this International Clinical Trials Day, Metrics Research applauds all stakeholders who contribute to developing and advancing clinical trials in Pakistan. This video features our CEO, Murtaza Hussain, and General Manager, Muhammad Sharib Syed, discussing Pakistan's evolving clinical trial landscape & the role of Metrics Research in promoting clinical trials in the country, achieving successful patient-centred outcomes and transforming healthcare globally. We look forward to continued advancements through research in Pakistan with innovation & excellence. #Internationalclinicaltrialsday #Clinicaltrialsday2024 #ClinicalTrialsinPakistan #ClinicalResearchProfessionals #healthcare #medicalresearch #MetricsResearch #ContractResearchOrganization #CRO #ResearchInnovationExcellence
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This was a very fruitful and solution-oriented workshop, with a clear call for future closer cooperation on both, product-specific advice and methodological guidance. We will continue keep working together in 2025 on solutions that support evidence generation addressing needs of both regulators and HTAs.