Heads of HTA Agencies Group’s Post

Alira Health publish this White Paper on ATMP´s regulation in Europe, thanks to my team Isabel De La Paz & Irene Asensio Gudiña for this incredible work. It provides an overview of the key changes that will impact access to innovative medicines and advanced therapies in the EU. #advancedtherapies #marketaccess #

Global Data Sharing in Clinical Research The European Medicines Agency (EMA) is working toward improving international collaboration through enhanced data sharing in clinical trials. By integrating with global registries, the goal is to increase transparency and accelerate the development of treatments worldwide. #GlobalCollaboration #ClinicalData #TransparencyInResearch #ClinicalTrials

The EMA Quality Innovation Group is hosting on 19th and 20th November a Listen and Learn Focus Group with industry and academia on Platform Technologies for Medicine Manufacturing. These have great potential to support public health for pandemic preparedness, personalised or individualised medicines, ultra-rare orphan indications and others. The meeting will discuss case studies and focus on scientific challenges and solutions that can support development in the future. A meeting report will be published on the EMA QIG webpage after the meeting.   🔗 Find out more - https://lnkd.in/djQC9nxj #MedicinesInnovation #QualityInnovation #PlatformTechnologies 

Generating Real-world evidence (RWE) to support evaluations by EU regulators and down-stream decision makers has been the focus of a recent pilot by the European Medicines Agency (EMA). In a review article, Stefanie Prilla along with (former) MEB colleagues Violeta Stoyanova-Beninska, Sabine Straus, Peter Mol and Liana Martirosyan present the key-learnings from the pilot and their perspective on how to maximize the potential of regulatory-led RWE generation. The review highlights Real-world evidence (RWE) as a great value for regulatory decisions. Additionally, early interactions between regulators and study requesters are crucial to ensure that research questions are well understood and addressed. Studies using real-world data (RWD) can thus complement evidence from clinical trials and fill evidence gaps during different stages of a medicine's lifecycle. This experience paves the way for more effective use of RWE in regulatory processes, ultimately enhancing decision-making in medicine safety and utilization. ➡ https://lnkd.in/eva2iq9m #RealWorldEvidence #RegulatoryScience Sophie Groeneveld, Alexandra Pacurariu, María Clara Restrepo-Méndez, Patrice Verpillat, Carla Torre, Christian Gartner, Frauke Naumann-Winter, Kieran Breen, Nathalie Gault, Sylvie Benchetrit, Brian Aylward, Maura O'Donovan, Jesper Kjær, Peter Arlett

Stuart McCully (RWR-Regs) delves into the nuances of the newly-announced FDA and National Institutes of Health draft glossary aimed at establishing consistency in clinical and #RWE research terminology. Read the latest Column at The Evidence Base® #rwd #realworldevidence #realworlddata #pharma #biopharma #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

Interestingly, the terms ‘real-world data (RWD)’ and ‘real-world evidence (RWE)’ are not included in the glossary....

🌍 Day 1 at the World Orphan Drug Congress 2024 kicked off with a strong focus on the EU Joint Clinical Assessment (JCA), one of the most significant healthcare policy shifts in a decade. 𝐊𝐞𝐲 𝐝𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧 𝐩𝐨𝐢𝐧𝐭𝐬: 🔑 The JCA, designed as a “one-stop shop” for regulatory and market access decisions, brings both opportunities and challenges. While it promises to streamline patient access, questions remain around pricing negotiations and national HTA processes 👥 Patient involvement was a hot topic, with many highlighting the gap between expectations and the current regulatory framework. Early scientific advice through Joint Scientific Consultations (JSCs) was flagged as critical for smooth navigation through the JCA process 👥 ⚖️ The path ahead is full of complexities, but with early planning and flexible approaches, companies can prepare for what’s to come Our 𝐃𝐚𝐲 𝟏 𝐒𝐮𝐦𝐦𝐚𝐫𝐲 𝐫𝐞𝐩𝐨𝐫𝐭 brings you all the highlights - https://lnkd.in/gMTER9DB #WODC2024 #EUHTA #PatientAccess #Healthcare #MarketAccess #Pharma #EUHTA #jointclinicalassessment

Missed out on Day 1 at World Orphan Drug Congress Europe, but want to know what was discussed? Our summary from day 1 is below

🗺 Missed Day 1 of World Orphan Drug Congress? Check out our Remap Consulting summary below 👇 #WODC2024 #EUHTA #PatientAccess #Healthcare #MarketAccess #Pharma #EUHTA #jointclinicalassessment

🌟 Reminder: Don't miss our webinar – 'Navigating US payer evidence needs to optimise market access' 🌟 If you're curious about what evidence US payers prioritise and whether you have what you need for a successful US launch, join us next Thursday (24th October) for a live webinar hosted by Mtech Access and Petauri Evidence. This session will provide valuable insights into the complex US payer landscape, helping you optimise your market access strategy. Learn more and register at 👉 https://lnkd.in/edYKUVt8 #marketaccess #USpayers #evidence #pharma #pharmaceuticals #lifesciences