The European Medicines Agency is carrying out a survey to gather information on your current experience with the Orphan Maintenance Assessment Reports (OMARs) / Orphan Designation Withdrawal Assessment Reports resulting from the review by the Committee for Orphan Medicinal Products (COMP) of the orphan designation criteria at the time of marketing authorisation application. The OMAR
The article summarises aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. The group provides examples of research innovation, and follow this with
The BMJ Journals published the article ‘Should children be vaccinated against COVID-19?’ which addresses the ongoing debate on the vaccination of children under 12 years of age against COVID-19. The relatively low risk posed by acute COVID-19 in children, and uncertainty about the relative harms from vaccination and disease mean that the balance of risk
The first paediatric expert patients training workshop, organised by TEDDY Network in collaboration with EURORDIS and the Sant Joan de Déu Research Foundation in the framework of the European Joint Programme on Rare Diseases (EJPRD) was kicked off on 26 November 2021. 15 participants aged from 12 to 18 years of age including patients with
The 1st International Conference on Rare Diseases and Paediatric Research took place virtually on 18-19 November 2021. Organised by 95, Rare Alliance Greece together with Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) and “Athena” Research Center in Information, Communication and Knowledge Technologies, the Conference was a great occasion to discuss the challenging topics related to
The CP4EUROPE (Strengthening National Child Participation Frameworks and Action in Europe) is a project funded by the European Commission under the DG JUST – Rights, Equality and Citizenship (REC) Programme. It was kicked-off on 1 April 2021 and will last 24 months until 31 March 2023. Annagrazia Altavilla, TEDDY Chair and Mariangela Lupo, TEDDY Networking
In the framework of the European Joint Programme on Rare Diseases (EJPRD), TEDDY Network is organising the first paediatric expert patients training workshops in collaboration with EURORDIS and the Sant Joan de Déu Research Foundation. The workshop is addressed to patients with a chronic rare disease, aged from 12 to 18, interested in the themes
We are happy to inform you that during the iCAN Summit in July 2021, iCAN launched a new learning module for clinical research, located on the iCAN website and freely accessible through this link. The new module was prepared with the support from the iCAN clinical research advisory team of community and industry leaders and the
TEDDY Network has been mentioned in the Opinion 136 "L’évolution des enjeux éthiques relatifs au consentement dans le soin" of the French Consultative Ethics Committee (Comité Consultatif National d’Ethique - CCNE) related to the ethical issues of the consent especially for vulnerable populations. The opinion is available here in French. The concept of informed consent
The 9th revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published on 1 July 2021. The guide offers a single web resource for methodological English language guidance in pharmacoepidemiology and for each topic covered, direct electronic access is given to internationally agreed recommendations. The new revision has been extensively amended and