News - November 28, 2019
The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply…. read more
News - November 18, 2019
As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated… read more
News - November 7, 2019
With 6 months to go before the application of the Medical Devices Regulation (MDR), the European Commission is putting pedal to metal in the implementation process! Two new Notified Bodies have indeed been recently designated to operate under MDR from… read more
News - October 14, 2019
The 10th World Orphan Drug Congress is taking place 12th–14th November, 2019 in Barcelona, Spain. Established as one of the largest and most established European orphan drug event, the event will propose an exciting speakers line-up and agenda covering the whole… read more
News - October 2, 2019
Earlier this month, the European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA) together with an Inception Impact Assessment (which can be downloaded here). The latter outlines three different options on… read more
