On May 17th 2019, representatives from EPTRI Coordination and the Ukrainian partner State Institute of Pediatrics, Obstetrics and Gynecology National Academy (UKR) had a meeting at the Ministry of Health in Kiev with Dr. Roman Ilyik, Deputy Ministry of Health, to discuss how the Ukrainian government can get involved and support EPTRI to fill in… Read More »
News
Evidence based data on preference of dosage forms are crucial for guiding the development of age-appropriate medicines. Often, preferences across different age groups are considered but studies on variations in preferences across populations, which may be crucial to acceptability, are lacking. To this aim, the EPTRI project developed a survey utilising country and age-adapted questions… Read More »
On October 5th, 2018, representatives from EPTRI and the Medicines Evaluation Board (MEB), the Dutch Regulatory Agency, had an informal discussion on the medicine development for the paediatric population, its gaps and need of concrete responses. The discussion arose following the reception from the MEB of the survey performed in Spring-Summer 2018 in the framework… Read More »
The European Medicines Agency (EMA) has released for public consultation the draft ICH guideline M10 on bioanalytical method validation – step 2b. A bioanalytical method is defined as a set of procedures used for measuring analyte concentrations in biological samples. The objective of the validation of a bioanalytical assay is to demonstrate that the assay is… Read More »
EPTRI’s abstract presented at the Academy of Pharmaceutical Sciences conference (APS@FIP), held in Glasgow on 7th September 2018, has been published on the British Journal of Pharmacy. The abstract entitled “EPTRI – European Paediatric Translational Research Infrastructure. Bridging the gaps of the paediatric excellence medicine”, was included under the “The Science of Differentiated Medicines” topic… Read More »
During the first day of the 3rd General Assembly meeting of EPTRI, held in Madrid at the Ministry of Health, Consumption and Social Welfare on the 27th of March, took place a Roundtable with seven young people members of Kids Albania, Kids Barcelona and Kids Bari. The activity was moderated by Begonya Nafria, coordinator of… Read More »
EPTRI is quite busy these days! On February 4th 2019, a meeting took place in Warsaw (Poland) at the Ministry of Health among the EPTRI Coordination Team, represented by Donato Bonifazi and Mariangela Lupo, Radosław Sierpinski, Adviser to the Minister of Health, and Marek Migdal, Director of the Instytut “Pomnik-Centrum Zdrowia Dziecka” – IPCZD (Children’s… Read More »
World Rare Disease Day is a very special event taking place the last day of February every year. The aim of this worldwide campaign is to raise awareness amongst society and policy-makers about rare diseases and their impact on the lives of patients and families. It is crucial to communicate the need of more research and improved social policies in… Read More »
This year EPTRI was invited to participate in the 3rd European Conference on Pharmaceutics, which was held in the city of Bologna (Italy) last March 26th. Nunzio Denora, from University of Bari and co-leader of the WP8 on paediatric medicines formulations and medical devices, presented a poster entitled “EPTRI: facilitating formulation science towards better medicines… Read More »
The EPTRI survey to map expertise and experience on units working in paediatric research in Europe, is approaching to its end. From April 2018, more than 240 units from 26 countries answered to the survey in one or more fields. In details, 82 units (33.8%) described their expertise in Human Development and Paediatric Medicines Discovery… Read More »