The e-learning “ICH-Good Clinical Practice (GCP) Training Course”, promoted by Consorzio per Valutazioni Biologiche e Farmacologiche in the framework of the GAPP project, meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified as necessary to enable mutual recognition of GCP training among trial sponsors as recognised by TransCelerate BioPharma. TransCelerate BioPharma Inc.
The Second paediatric strategy forum, Medicinal Product Development for Mature B cell Malignancies in Children, jointly organised by ACCELERATE and the European Medicines Agency (EMA), will be held in London at the EMA premises on 13 and 14 November, 2017. The event will focus on mature B cell malignancies (lymphoma and leukaemia) in children and is aimed
Patients involvement in the development of paediatric clinical trials is recognized as an important added value at European and international level and an essential contribution to paediatric clinical research. To foster patients’ empowerment, advocacy groups including young patients and healthy youngers, named YPAG (Young Persons Advisory Group), have been established from New Zealand to France,
In December 2016, the European Parliament adopted a Resolution on the Regulation on Paediatric Medicines. TEDDY has contributed to it in providing some suggestions and comments in the drafting phase. The document acknowledges that relevant results have been achieved following the entry into force of the Paediatric Regulation. In the meantime, the burdens still remaining
Save the date – International Paediatric Clinical Trial Day. “Helping children create lives they deserve”. Ospedale San Raffaele, Milan (Italy), May 9th, 2017.
On May 9th, 2017, the Italian Association of Contract Research Organizations (AICRO) will Organize in Milan, at the San Raffaele Hospital, the International Pediatric Clinical Trial Day Entitled "Helping children create lives they deserve". The meeting is organized in collaboration with San Raffaele Hospital, TEDDY Network and INCiPiT (the Italian network for pediatric clinical
The Masters Certificate of Professional Development in Medicines Use in Paediatrics and Neonates is certified postgraduate course in advanced paediatric clinical practice, open to all healthcare professionals with an interest in medicines use in paediatrics and neonates with sufficient contact time with patients. The course is a CPD (Continuing Professional Development) course in Medicines Use
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
Imagine going to your doctor only to be told that they don’t know what is happening to your body, that they don’t know what your disease is. Imagine that they can diagnose your disease but tell you that there is no cure or even treatment available. Or that the treatment available is not fully effective
PARIS (31 January 2017) – 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. Children
TEDDY, the first paediatric Network of Excellence in Europe, makes the point on research and innovative cares for children.
The Italian contribution and the new INCiPiT research network coordinated by the University Paediatric Hospital Bambino Gesù. 2016 is the first year in which a significant increase of new drugs approved by the EMA (European Medicines Agency) for the paediatric population has been observed. There are 36 new molecules now in distribution: drugs for the