Category: Stakeholder news and views
Current status of the Clinical Trials Regulation
In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable. What is the aim of the ‘new’ regulation, what issues does it address, and why was its application delayed?
EU Elections and Health Policy
2019 will see significant changes within the European institutions. The first already took place in late May, as 50% of EU citizens – the highest turnout since 1994 – went to the ballot box to elect their Members of the European Parliament (MEPs). The result: Confirmation that nationalism and Euroscepticism are on the rise, and a set-back of center political parties.
Rolling out CAR T across Europe
Patient-centric treatments such as gene and cell therapies have been a game-changer in tackling hematological disorders. Nonetheless, their development remains slow and erratic, limiting benefit for patients.
Tackling Sickle Cell Disease: the need for a European approach
Learning how to recognize and treat a disease that is relatively new to many parts of Europe, and spreading, is crucial to limit, if not avoid, irreversible impact and provide proper care to patients.
HARMONY: Big data for better and faster treatment
Gathering clinical, genetic and molecular information into a single database: this is the challenge taken on by the HARMONY Alliance. By bringing together data currently scattered across different clinical trial databases and registries, the HARMONY Alliance is harnessing the enormous potential of Big Data and Big Data analytics to deliver insights that will help improve the care of blood cancer patients.
GAPP Joint Action
Joint Actions are projects designed and financed by Member State Authorities and the EU to address specific priorities under the EU Health Program.
Hospital pharmacists and regulators lead the way on shortages
EHA welcomes initiatives but calls for more focus on causes
Medicine shortages have a negative impact on the quality and cost of treatments and on patient access to the best possible care. EHA has helped flag the problem with policymakers and regulators, but lack of data and understanding of the causes make it notoriously difficult to tackle.