📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”. 📣 There was huge interest from the community with over 350 participants registered, and balanced representation from HTA and regulatory perspectives. The webinar was hosted by the NCPE - National Centre for Pharmacoeconomics in collaboration with the HTA Coordination Group Methodology and Procedures Subgroup, the Heads of HTA Agencies Group and the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and Methodology Working Party (MWP). 👩🏫 Presentations described the distinct remit of HTA and EMA but also where the synergies lie and how through discourse on the challenges, uncertainty can be better understood in the context of these remits. A common understanding will allow for more successful employment of methodologies and solutions to manage uncertainty. 👉 This is the first of an ongoing scientific collaboration between HTA and regulators and we look forward to more fruitful discussions in Autumn.
Heads of HTA Agencies Group’s Post
More Relevant Posts
-
📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”.
📰 Health technology assessment and regulatory methodologists came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”. 📣 There was huge interest from the community with over 350 participants registered, and balanced representation from HTA and regulatory perspectives. The webinar was hosted by the NCPE - National Centre for Pharmacoeconomics in collaboration with the HTA Coordination Group Methodology and Procedures Subgroup, the Heads of HTA Agencies Group and the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and Methodology Working Party (MWP). 👩🏫 Presentations described the distinct remit of HTA and EMA but also where the synergies lie and how through discourse on the challenges, uncertainty can be better understood in the context of these remits. A common understanding will allow for more successful employment of methodologies and solutions to manage uncertainty. 👉 This is the first of an ongoing scientific collaboration between HTA and regulators and we look forward to more fruitful discussions in Autumn.
-
-
📢 Help shape the future of regulatory science! Gaps in regulatory science need to be addressed to enhance medicine development and evaluation. To tackle these challenges the following documents have been published: ➡️ A draft concept paper on the HMA-EMA European Platform for Regulatory Science Research, which aims to foster collaboration among academic regulatory science researchers and regulators in Europe and beyond. To find out more about its main objectives and proposals dive into the concept paper and share your comments with us. ➡️ An updated draft of regulatory science research needs 📅 Review the documents and have your say by 18 December 2024: https://lnkd.in/e-yrZx_3 #RegulatoryScience #ResearchAndInnovation #EUScience #PublicHealth
-
📢 Help shape the future of regulatory science! Gaps in regulatory science need to be addressed to enhance medicine development and evaluation. To tackle these challenges the following documents have been published: ➡️ A draft concept paper on the HMA-EMA European Platform for Regulatory Science Research, which aims to foster collaboration among academic regulatory science researchers and regulators in Europe and beyond. To find out more about its main objectives and proposals dive into the concept paper and share your comments with us. ➡️ An updated draft of regulatory science research needs 📅 Review the documents and have your say by 18 December 2024: https://lnkd.in/e-yrZx_3 #RegulatoryScience #ResearchAndInnovation #EUScience #PublicHealth
Open consultations | European Medicines Agency (EMA)
ema.europa.eu
-
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
Fourth listen-and-learn focus group meeting of the Quality Innovation Group | European Medicines Agency (EMA)
ema.europa.eu
-
Navigating the complexities of European Medicines Agency (EMA) and HTA body consultations? The new parallel EMA/HTA Scientific Advice process offers a streamlined solution. By consolidating advice from both the EMA and multiple European HTA bodies into a single process, it reduces redundancy and enhances efficiency. Starting January 2025, joint scientific consultations will be governed by the new EU HTA Regulation, transforming the landscape of regulatory interactions. Having engaged with EUnetHTA scientific advice, we are uniquely positioned to support you through this pan-European scientific advice journey. Our experience ensures that you receive comprehensive guidance tailored to meet the evolving regulatory requirements. Explore our recent case study below for more insights. If you're seeking EMA/pan-European HTA scientific advice, let's connect and discuss how we can assist you. #EMA #HTA #ScientificAdvice #EURegulation #Healthcare
-
I am pleased to announce the publication of the report on Real-world data and real-world evidence in regulatory decision making by the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII. It aims to describe the potential uses of RWE for decision making; RWD and data sources; key considerations in the regulatory use of RWE; and ethics and governance issues in using RWD. We hope this report furthers discussions and contributes to the future development of RWD/RWE in regulatory decision making, thereby helping to maximise the benefits they can bring to public health. See the link below. https://lnkd.in/etX2Cm38
Real-world data and real-world evidence in regulatory decision making • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
https://cioms.ch
-
RWE Analyst | Pharmacovigilance & Pharmacoepidemiology Expert | Clinical Trials & Drug Safety | Data Science in Healthcare
Today, the Council for International Organizations of Medical Sciences (CIOMS) published the consensus report of the Working Group XIII " Real-world Data and Real-world Evidence in Regulatory Decision Making". The report can be downloaded at this link. https://lnkd.in/dt4QikcY I am happy to see my name within the list of public consultation commentators.😊 #CIOMS #RealWorldData #RealWorldEvidence #RegulatoryDecisionMaking #rwd #rwe
Real-world data and real-world evidence in regulatory decision making • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
https://cioms.ch
-
Chief Scientific Officer and Director of HTA Methods and Engagement, ICER; Director, Value Measurement & Global Health Initiatives, Tufts CEVR; Co-Author, "The Right Price: A Value-based Prescription for Drug Costs"
Hot off the press -- the 2nd paper in our series that highlights the challenging multi-stakeholder work we did at the Bellberry symposium in June 2023 on "accelerated access" to medicines. This paper outlines key near-terms steps that can be taken to bolster current systems: https://lnkd.in/ec33Csjr
Putting Meat on the Bone: How to Fast-Track Innovative Medicines to Those Who Need Them and Generate Data to Justify Continued Use
academic.oup.com
-
#AOTMiT & EU HTA European Commission adopted an Implementing Regulation that sets out the rules for cooperation with the European Medicines Agency #EMA in the joint work carried out under the #HTA Regulation. These rules define the information to be shared: ➡️for planning and forecasting of joint clinical assessments (JCA) and joint scientific consultations (JSC); ➡️for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures; ➡️on general scientific and technical matters related to health technology assessment.
-
-
A great step forward, Mariette Boerstoel-Streefland! This further reiterates our message at Cisiv Ltd- real life is not a trial. In the real-world evidence (RWE) space, it's hard to ignore that there is a strong surge of medicines regulatory agencies expressing a growing openness to consider RWE to support claims of efficacy, safety and overall informed regulatory decision-making. This comprehensive analysis by Council for International Organizations of Medical Sciences Working Group XIII, addresses key considerations and ethical issues, which are essential for advancing the integration of RWD/RWE in the regulatory landscape. We look forward to seeing how these insights will shape the future and maximise public health benefits. #realworldevidence #realworlddata #latephase
I am pleased to announce the publication of the report on Real-world data and real-world evidence in regulatory decision making by the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII. It aims to describe the potential uses of RWE for decision making; RWD and data sources; key considerations in the regulatory use of RWE; and ethics and governance issues in using RWD. We hope this report furthers discussions and contributes to the future development of RWD/RWE in regulatory decision making, thereby helping to maximise the benefits they can bring to public health. See the link below. https://lnkd.in/etX2Cm38
Real-world data and real-world evidence in regulatory decision making • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
https://cioms.ch
