NEWSLETTER JUNE 2019
Designing the framework for a new European paediatric research infrastructure
I am very pleased to welcome you to the fourth newsletter of the EPTRI (European Paediatric Translational Research Infrastructure) project. Before the summer break, we would like to share with you some updates about EPTRI and other events of your interest. Please take some time and enjoy the content of this newsletter.
The mapping of the users is just ended, and we are happy to acknowledge a strong interest. The draft of the EPTRI Conceptual Design Report is now ready and several deliverables are going to be submitted to the European Commission. The first Official Report will describe all the activities carried on in the first 18 months of the EPTRI project.
The call for feasibility studies is now open for proposals. EPTRI can therefore have an outstanding opportunity to provide proof of viability showing a solving, challenge-oriented, strategy to synchronize what is already existing, and maximize the outcomes’ impact thus creating novel solutions in the process of developing new drugs and treatments for diseases that affect children.
On behalf of all EPTRI partnership, I wish you a pleasant summer holiday!
WP2 “Governance and Sustainability” Leader
EPTRI Stakeholders Roundtable Summary Report Released!
Representatives from paediatric networks, Research Infrastructures (RIs), European Reference Networks (ERNs), charities, patients’ associations, Young Persons Advisory Groups (YPAGs), companies’ federations, regulatory agencies and legislative representatives had a very productive conversation during the stakeholders roundtable held in the framework of the 3rd General Assembly of EPTRI in Madrid, Spain, on March 27th 2019.
Report from the meeting with the Dutch Regulatory Agency
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.
Launch of the feasibility studies call
A call for application for the preparation of EPTRI feasibility studies has been launched.
Feasibility studies are aimed to test the process, the scientific interest, the availability of requested services and facilities needed to conduct paediatric research in the areas of EPTRI competence.
New Motion Graphic to present the EPTRI Project
A new motion graphic illustrating the general structure and goals of the EPTRI project has been published on our Youtube channel. This material is intended to give support to the partners and supporters of the project during their presentations in conferences, meetings or workshops. You can access this new communication material in the following link.
Preliminary results of the survey about oral formulations
The EPTRI project developed a survey utilising country and age-adapted questions to quantify children’s experience with taking various pharmaceutical formulations.
EPTRI user survey is closed: preliminary results soon available!
An online survey of users has been designed by Work Package 9, leaded by Liverpool University, with the aim to identify potential service users and the nature and extent of their needs for integrated approaches to paediatric drug development.
EMA released for public consultation the draft ICH guideline M10 on bioanalytical method validation
The European Medicines Agency (EMA) has released for public consultation the draft ICH guideline M10 on bioanalytical method validation – step 2b.
Ukrainian Ministry of Health supports EPTRI
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.
The Israeli Ministry of Health supports EPTRI
We are very glad to announce that the Chief Scientist of the Israeli Ministry of Health has signed a letter of political support to EPTRI.
EPTRI at the IV Seminar on Clinical Trials Phase I in Spain
EPTRI has participated in the IV Seminar on Clinical Trials Phase I celebrated recently in Spain. The meeting was held on June 5th at the University Hospital La Paz in Madrid.
EPTRI at the 67th Meeting of the Spanish Pediatric Association
EPTRI has participated in the 67th National Meeting of the Spanish Pediatric Association (AEP) celebrated in Burgos (Spain). EPTRI was presented in the roundtable titled “AEP projects”. In this session, the Spanish Pediatric Association described the different programmes and projects in which the entity is involved as a supporter.
September 10-12th, Malmö, Sweden.
September 11-13th, Greenwich, UK.
October 8-11th, Lübeck, Germany.
November 10-12th, Tokyo, Japan.
EVENTS OF INTEREST
June 19-21st, Leiden, the Netherlands.
September 23-27th Rome, Italy.
September 24-25th, Vienna, Austria.
October 2-4th Rome, Italy.
October 23-25th Leuven, Belgium.
October 15th Barcelona, Spain.
November 11-12th Berlin, Germany.
November 20-21st, Brussels, Belgium.