News

Annagrazia ALTAVILLA, Chair of TEDDY, appointed as consultant/expert of the Council of Europe for children focused activities foreseen in the new COE “Strategic Action Plan on Human Rights and Technologies in Biomedicine”

Annagrazia ALTAVILLA, Chair of TEDDY, has been appointed as consultant/expert of the Council of Europe - Bioethics Division, within the new DH -BIO Strategic Action Plan on Human Rights and Technologies in Biomedicine (2020-2025). This plan provides specific considerations on children and paediatric population, underlining that important human rights challenges are also emerging through established

September 29th, 2020|

Public consultation on European Medicines Agencies Network Strategy to 2025

The European medicines regulatory network (EMRN) represents a unique response to the challenge of regulating human and veterinary medicines across a diverse group of countries. It includes the national competent authorities (NCAs) of the 27 EU Member States plus those of Iceland, Liechtenstein and Norway, and also come together under the aegis of the Heads

September 29th, 2020|

Good Lay Summary Practice: TEDDY answered to the Public Consultation

The upcoming Clinical Trial Regulation requires the development and dissemination of Lay Summaries of clinical study results from commercial and non-commercial sponsors. However, there is no guidance for all types of sponsors on how best to handle the development process of Lay Summaries and how best to ensure reliable dissemination so that the ultimate goals

September 29th, 2020|

Enpr-EMA comment to FDA docket on Rare Disease Clinical Trial Networks submitted

The Food and Drug Administration launched a docket to require inputs and comments from patients, patient advocates, the scientific community, health professionals, regulatory and health authorities and general public regarding practical steps to establish a rare diseases clinical trial network. Enpr-EMA response to the FDA’s request for information and comments on Rare Disease Clinical Trial

September 29th, 2020|

EMA approved a new treatment for children with chronic kidney disease

EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood

September 29th, 2020|

EMA published the Guideline on registry-based studies. Launch of Public Consultation

EMA has published the draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence. Studies based on patient registries generate real-world evidence that can complement the knowledge gained through pre-clinical studies and clinical trials during the development

September 29th, 2020|

The Lancet 2020 Campaign on child and adolescent health

The world’s leading independent general medical journal the Lancet started “The Lancet 2020 Campaign on child and adolescent health” with the aim to reiterate the centrality of child survival and wellbeing in global development. Several initiatives have been proposed to achieve this goal. In February, a new WHO–UNICEF Lancet Commission put children firmly at the

September 29th, 2020|