News - November 28, 2019

MDR: Second Corrigendum aims at Class 1 Devices

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. With this corrigendum, all Class… read more

News - November 18, 2019

EMA Regulatory Science Strategy: Our Proposals

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 and collaborative regulatory framework.

News - October 14, 2019

World Orphan Drug Congress – 12/14 November

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 orphan drug landscape. The 12th… read more

News - October 2, 2019

European Commission publishes options for a new EMA Fee Structure

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 how the EMA fee system… read more