101 hits for »HTA «
…Palma, Senior Director Global Head of Market Access & Access Policy at SOBI, and Alexander Natz, EUCOPE Secretary-General share their views on the EU HTA file, including the recent Council compromise on an HTA proposal. Both experts exchange on the implications for the sector, for…
…to patients receiving the best medicines possible don’t result in undesirable outcomes. So regulation surrounding research and development of new health interventions like medicines and devices need to be well-integrated, appropriate, and flexible. Similarly, health technology assessments (HTAs) and pricing regimes need to encourage innovation…
…also taking place with regard to HTA and P&R. This combination of commercial and legislative developments will have long-term implications on ATMPs and the competitiveness of the EU. Suffice it to say, there is a lot happening when it comes to ATMPs, and with the…
…EU HTA procedures, and debates the European Health Data Space proposal, it is the opportune moment to update the EU landscape to embrace RWE in the context of ATMPs, building a futureproofed system. Our latest position paper explores the role and acceptability of RWE across…
…including a summary of EU HTA regulations, and the EUnetHTA21 collaboration meetings Trends in supranational HTAs other than EUnetHTA – lessons learned Legal framework, the pharma package, how unmet medical need and orphan designation may impact assessment PICOS frameworks and challenges/opportunities in dealing with potentially…
…industry today? We perceive a multitude of uncertainties on the horizon, including political instability, economic fluctuations, financial constraints, heightened competition, the impact of artificial intelligence, and a shortage of human resources. However, the impending European Health Technology Assessment (HTA) procedure stands out as a major…
LIFE SCIENCE LECTURES – Webinar Series Episode 4 – 14 December 2023 (15:00 – 15:40 CET) Leveraging early advice opportunities in EU HTA On the fourth episode, we discuss how best to navigate early advice opportunities with the new EU health technology assessment (HTA), which…
The new EU HTA requirements: How to prepare for market launch from January 2025 Episode 7 – 17 July 2024 (16:00 – 17:00 CET) In this webinar, EUCOPE experts will provide you with the rundown on the new EU HTA procedure, so that you are…
…the EMA and HTA bodies in both pre- and post-marketing contexts; Regulatory streamlining, including reducing approval timelines to bring them in line with global standards; The European Commission must foster an environment that promotes, rewards, and encourages research and development in Europe in the context…
…the importance of aiming for increased transparency in pricing mechanisms, and his keenness to put this high on both the Council’s and the European Parliament’s agendas. EUCOPE, in response, elaborated on the expected benefits of European joint clinical HTA, if properly set up. With regards…
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