Last January, the European Commission launched the consultation on the European Health Emergency Preparedness and Response Authority, HERA for short. How can we make sure this new agency finds its way? Clarity on its roles and responsibilities will be needed. See our take in this… read more
As demonstrated by the fight against COVID-19, Artificial Intelligence (AI) has the potential to drive change and improve efficiency and accessibility in healthcare. From compounds design in medicines development to faster patient screening and diagnosis to hospital management (to name but a few applications), AI-based… read more
EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe. EUCOPE calls for a comprehensive Pharmaceutical Strategy… read more
The EU and US Biotech Sector’s Response to COVID-19 On 24 September, EUCOPE, together with BIO, hosted a webinar focusing on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and… read more
On 24 September, EUCOPE, together with BIO, will host a webinar focused on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and US. The agenda will tackle: Measures taken by… read more
On the verge of the publication of the EU industrial strategy in March, EUCOPE shared the expectations and ambitions of its membership for a coherent strategy that harness Europe’s untapped potential: small and medium biopharma. The mission letter from President von der Leyen to Commissioner Kyriakides… read more
As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives for the acceleration of development… read more
The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every… read more
The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical implications concerning the need for… read more
The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The… read more
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