News

On 2th-4th October 2019 Bambino Gesù Children’s Hospital in partnership with the International Society of Pediatric Innovation (iSPI) will organise the Conference “Shaping the Future of Paediatrics” at Centro Congressi Piazza di Spagna in Rome. The Conference will feature demo sessions on innovation in paediatrics and speeches about 5 main topics: Advances in clinical paediatrics and

On 25th and 26th November 2019, the RESTORE First Advanced Therapies Science Meeting will take place in Berlin. The conference will highlight the science behind Advanced Therapies with a jam-packed agenda featuring leaders in science and technology development. TEDDY members have taken this occasion to bring TEDDY network perspective on advanced therapies in paediatrics. In particular 3

The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could potentially be used in the paediatric population, have not been studied in the relevant paediatric age

Type 2 diabetes is a chronic disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. It can lead to serious complications if a person does not receive treatment. According to the World Health Organization,

The European Joint Programme on Rare Diseases (EJPRD) is a Co-fund action aimed to create a comprehensive, sustainable system allowing virtuous circle between research, care and medical innovation. TEDDY Network participates as Partner in this project and all of its Members are considered as Third Parties. The EJPRD has the main objective to create a

The Commission is preparing for the crucial phases of the implementation of Horizon Europe (HE), the next EU research and innovation programme (2021-2027) with a proposed budget of 100 billion. In view of an intensive co-design approach, the Commission has launched an online consultation that will be part of a process to shape the European

The European Union electronic Register of Post-Authorisation Studies (EU PAS Register) is a collection of non-interventional post-authorisation studies (PAS) and was launched in 2010 by ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) to provide a free resource in Europe in the areas of pharmacoepidemiology and pharmacovigilance. Currently, 1500 studies were registered in the EU

The Italian Medicines Agency AIFA has just released a safety communication about the use of medicines containing domperidone. Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes since 1970s, with the first approval in Belgium in March 1978. The AIFA communication

We are happy to announce that the TEDDY Network is involved as supporter in RESTORE, a large-scale Research Initiative with the scope to create a consortium aimed to build a coordinated, financially strong, academia-industry partnership in order to tackle the main interdisciplinary science and technology challenges for advanced and innovative health therapies. The consortium is

EMA has launched a public consultation on the draft ICH Guideline E19 relating to optimization of safety data collection in late-stage pre-approval or post approval studies and promoting selective safety data collection to limit useless burden to study participants (when the safety profile of a drug is sufficiently characterized). This guideline explores under what circumstances