Category: Stakeholder news and views
Help disseminate IVDR Questionnaire - Share with diagnostic laboratories in your...
The new EU Regulation on in vitro diagnostic medical devices (IVDR) will come into full effect per May 26, 2022 and will have substantial consequences for diagnostic laboratories.
EHA has joined the European Cancer Organisation - a perfect match on objectives ...
The European Hematology Association (EHA) has joined the European Cancer Organisation, a not-for-profit federation of organizations working in cancer at the European level. EHA’s membership application was approved by the General Assembly of the European Cancer Organisation on November 18, 2020.
Reducing bureaucracy in clinical trials: now is the time!
Excessive administrative demands lead to rising costs and complexity, stagnation of clinical research in Europe, fewer academic clinical trials and limited access to innovative treatments.
Call for urgent action on medicine shortages in Europe
EPHA published a position paper on medicine shortages in Europe. EHA welcomes its recommendations to address the increasing shortages crisis, which threatens patient outcomes and patient safety.
EHA’s Prof Jäger elected HCPWP co-chair
On September 24, Prof Ulrich Jäger, former EHA President and current member of the EHA European Affairs Committee, was elected as co-chair of the Health Care Professionals Working Party (HCPWP) of the European Medicines Agency (EMA). He will lead the working party during its 2019-2022 mandate alongside Juan Garcia-Burgos, EMA’s head of Public Engagement.
Addressing the bureaucracy challenge
EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research. Regulators, patient organizations, the European Commission and industry representatives were invited for a day-long discussion at EHA offices, building on an informal dialogue with the European Medicines Agency (EMA) that had been initiated by a group of prominent clinical researchers.
FUNDING ALERT: Calls published on ATMPs, T cells and cancer research
In recent weeks, two Calls for proposals were published that offer relevant funding opportunities for hematologists: IMI2 – 18th Call for proposals, a jointly funded partnership between the European Union, and Horizon 2020 – Call for cancer research proposals, call for research proposals in the category ‘Societal Challenge 1 (SC1): Health, demographic change and wellbeing’. .
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.