On May 5th, 2017, the European Medicines Agency (EMA) and the European Commission have published the first information guide for healthcare professionals on biosimilar medicines. This drug category refers to biological medicines highly similar in terms of safety, quality and efficacy to a biological medicine (the “reference medicine”) that has already been authorized. Biological medicines
The European Medicines Agency’s (EMA) published the 2016 annual report describing its work and impact in the area of medicines and health during last year. The report highlights the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real
The new European Paediatric Translational Research Infrastructure (EPTRI) has been presented at the 16th meeting of the European Society for Developmental Perinatal and Pediatric Pharmacology (ESDPPP) Congress, held in Belgium on 20-23 June 2017, in the section “New tools and approaches to further improve paediatric pharmacotherapy and studies “.
Despite the correct application of blood transfusions and chelation treatments, beta thalassemia patients have many complications. Systematic population analyses on types and frequency of these complications are very few. An article entitled “Pattern of complications and burden of disease in patients affected by beta thalassemia major” has now been published on Taylor & Francis Online
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
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