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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...
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...
The European Medicines Agency (EMA) has launched a pilot project to i) assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as...
The U.S. Food and Drug Administration (FDA) has recently published a guidance on neonatal clinical pharmacology studies. This guidance is intended to assist sponsors of investigational new drug applications (INDs) as well as applicants of new drug applications...
Good paediatric biomarkers are critical for the decision-making process in child healthcare. However, reference intervals used in pediatric care today remain highly inconsistent across a broad range of common clinical biomarkers. This review paper assessed...
The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors and no...
The European Medicines Agency (EMA) recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), Upstaza (eladocagene exuparvovec) and a marketing authorisation under exceptional circumstances for Zokinvy (lonafarnib). ...
We are pleased to launch our March newsletter. In 2022 we will continue to advance paediatric research initiatives. We have several exciting news: our podcast that will present all EPTRI’s activities and opportunities, our new website and Twitter account, new...
1) XVI European Patients’ Rights Day 2022. The "Conference on the Future of a Healthy Europe: Taking part in the decision-making process on health priorities” will be held on April 20th–21st 2022 from 14:30 to 16:00 CEST. The aim is to provide a multi-stakeholder...
EPTRI in collaboration with EJP RD is organizing this workshop on 4th-5th July 2022 in Bari, Italy. The course aimed at facilitating discussion and exchange of knowledge on the M&S methodologies as well as innovative/promising strategies for facing complex...