Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation
The workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union.
The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry.
EPTRI – European Paediatric Translational Research Infrastructure.
A great success for paediatric medicines development.
The ID-EPTRI (European Paediatric Translational Research Infrastructure) project, coordinated by CVBF and submitted within the INFRADEV-2016-2017 single-stage call for proposals, aimed to create the framework for a new paediatric Research Infrastructure (RI) has been successfully evaluated and granted 3.00 million Euro in funding from the European Commission.
The project will develop a new RI, EPTRI, that is complementary to the existing Biomed Research Infrastructures acting as a ‘Paediatric Common Service’ in the ESFRI Scenario. The project involves 26 partners from EU and non-EU countries including consolidated RIs, top-level universities, scientific and clinical centres of excellence in Europe and is aimed to create a Conceptual Design Report (CDR) to realize the European paediatric RI.
INCiPiT will actively participate into the project.
INCiPiT and the Independent Research on drugs funded by Italian Medicine Agency –AIFA Call 2017
The Italian Medicine Agency (AIFA) has launched the seventh call for proposals on independent research (Bando AIFA 2017)
It represents one of the strategic tasks assigned to AIFA by legislation which goes to reward projects able to enrich clinical and therapeutic knowledge in areas of lesser interest for profit research.
The call for proposals is aimed at investigators, public and private entities operating in the field of health care and scientific research not for profit.
In this call, five main areas (three in Bando AIFA 2016) of drug research has been included in the program.
The deadline for submitting the project will be the 31th of January 2018.
IMI2 launched the call
The Innovative Medicines Initiative (IMI), the joint undertaking between the European Union and the pharmaceutical industry association EFPIA, has launched IMI2 – Call 10, with a specific topic dedicated to the paediatric clinical trials.
Specifically, the call is focused on the creation of a large collaborative paediatric network that will facilitate the development and availability of new drugs and other therapies, and the expansion of knowledge about drugs currently used in the paediatric population.
INCiPiT will participate to this call as the Italian National Hub for the paediatric research.
Promoting high-quality clinical research in children through strengthened international collaboration.
In London on 16th May 2017 the ninth annual workshop of the European network of paediatric research at the EMA (Enpr-EMA) will take place.
Medicines for children: the point on research and innovative cares
TEDDY, the first paediatric Network of Excellence in Europe, has made the point on research and innovative cares for children. The Italian contribution and the new INCiPiT research network coordinated by the Paediatric Children Hospital Bambino Gesù was presented during a meeting held on December 19th 2016 at the Hospital.
Towards better medicines for children: PedCRIN project builds research infrastructure
On 31st of January, the European Clinical Research Infrastructure Network (ECRIN) has announced the launch of the Paediatric Clinical Research Infrastructure Network (PedCRIN).
The three-year project brings together ECRIN and the founding partners of the European Paediatric Clinical Trial Research Infrastructure (EPCT-RI) to develop capacity for the management of multinational paediatric clinical trials.
Launch of PedCRIN call for multinational clinical studies in children and neonates
The Paediatric Clinical Research Infrastructure Network (PedCRIN) has launched the call for multinational clinical studies in children and neonates. PedCRIN is a four-year project funded by the European Union’s Horizon 2020 programme, aimed to bring together the European Clinical Research Infrastructure Network (ECRIN) and the founding partners of the European Paediatric Clinical Trial Research Infrastructure … Continue reading “Launch of PedCRIN call for multinational clinical studies in children and neonates”