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Biosimilars approved in the EU are interchangeable. The EU experts on biosimilar medicines (Biosimilar Medicines Working Party or BMWP) and the Heads of Medicines’ Agencies (HMA) Biosimilar Working Group have drafted a joint statement explaining the rationale for...
This conference entitled “Launch of Charter for EU Cooperation to Enable Safe and Timely Patient Access to Advanced Therapies in Europe” has been organized by the TRANSFORM MEP Interest Group of the European Alliance for Transformative Therapies. The in-person event...
The 20th International Conference on Pharmaceutical Medicine – ICPM, an event on biomedical science, pharmaceutical research and technology under the theme “What lies ahead in Pharmaceutical Medicine” will be held next week, on October 19th until the 21st, in Athens...
Cystic fibrosis (CF) is a life-shortening, monogenic, autosomal-recessive disorder, and has an estimated incidence of 1:2500 to 1:3500 live births. Newborn screening (NBS) has been implemented for CF in many European countries, Australia, New Zealand, Canada, and...
This important report has been published by the Council for International Organizations of Medical Sciences (CIOMS) Working Group XI. The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation,...
The 2022-2026 Workplan of the Accelerate Clinical Trials in the EU (ACT EU) initiative has been published by the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA). The ACT EU, launched on January 2022, seeks to...
The webinar is organized by the European CRO Federation (EUCROF) and it will be held online on October 5th from 10:00 to 11:30 am (CEST). People-centered clinical trials are a growing concept in Clinical Trials, so it is crucial to foresee and develop initiatives...
The US Food and Drug Administration (FDA) has approved Bluebird Bio’s one-time beta-thalassaemia treatment Zynteglo, also known as betibeglogene autotemcel (beti-cel), as the first cell-based gene therapy for the treatment of patients with beta-thalassaemia who...
The Heads of Medicines Agencies - European Medicines Agency (HMA - EMA) Big Data Steering Group is organizing the 3rd EU Big Data Stakeholders Forum on Thursday, 1 December 2022. The objectives of the meeting are: Inform stakeholders on the delivery of data...
In clinical practice, patients are often prescribed more than one drug which can result in a drug-drug interaction (DDI). The European Medicines Agency (EMA) has published the “Draft International Council for Harmonisation (ICH) Guideline M12 on drug interaction...