France Biotech, with the help of the European health innovation ecosystem, is organising a HealthTech Investor Day in Paris on 24/25 June 2019. This European business event aims to connect leading investors (European, American and Asian), pharmaceuticals companies and C-level executives from European innovative companies… read more
In the event the United Kingdom leaves the EU without a deal, access to medicines may be affected and to alleviate any doubts, the EMA has published a questions & answers document on the preparatory work to prevent medicine shortages. If at any point in… read more
Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting of 14 February, the European Commission (EC) updated the ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play of the coming… read more
A report, commissioned by EUCOPE points out the uneven alignment of Pricing & Reimbursement (P&R) systems in five European countries with the 2015 ORPH-VAL Principles. Back in 2015, in an effort to improve consistency in P&R processes for Orphan Medicinal Products (OMPs) and avoid delays… read more
EUCOPE, together with SME Connect and SME Europe is organising an event at the European Parliament on the opportunities and challenges of gene and cell therapies – 05 March. Entitled ‘From Discovery to Access: How can we ensure Europe is at the forefront of innovation… read more
On 30 January, the German government has agreed on a draft Act for more safety in the supply of pharmaceuticals (“GSAV”). Although the wording of the original bill has been amended since it was released by the Ministry of Health last year, it still contains… read more
As of 9 February 2019, most prescription medicines supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. These mandatory safety features are implemented through a delegated regulation that comes into application… read more
EURORDIS, the non-profit alliance representing rare diseases patient organisations will organise its 3rd Multi-Stakeholder Symposium on Improving Patients’ Access to Rare Disease Therapies on 13-14 February 2019 in Brussels, Belgium. The event will bring together stakeholders from various backgrounds to discuss sustainable solutions to improve… read more
EUCOPE, in collaboration with its member Sidley, as well as Navitas and PWC, is organising a conference on the 21st of February in Brussels, to discuss recent developments in pharma and medical devices law. The event will bring together senior and former members of the… read more
The European Medicines Agency (EMA) has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. Patient registries are organised systems that use observational methods to collect uniform data on a population defined… read more