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 The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.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...
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...
Brexit: which will be the changes in regulatory procedures and guidelines in paediatrics?
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made...
FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
The Food and Drug Administration (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19....
Brexit: which will be the changes in regulatory procedures and guidelines in paediatrics?
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. The European Medicines Agency (EMA) has made...
EJP RD General Assembly Meeting
The European Joint Program on Rare Diseases (EJP RD) is glad to announce its second General Assembly (GA) and Consortium Meeting that will take place from 14 to 18 September 2020 online, due to the current COVID-19 crisis. The EJP RD brings over 130 institutions...
EMA consultation: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Q&A
The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers. The guideline is available at...
A new phase for the European Paediatric Translational Research Infrastructure: EPTRI-IA
EPTRI (European Paediatric Translational Research Infrastructure), the European project funded within H2020 Infradev-01-2017 call for proposals and coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) reached the end of its exciting journey,...
TEDDY comments to EMA Discussion Paper: Secondary Use of Data for Medicines and Public Health Purposes
The European Medicines Agency (EMA) is preparing the guidance on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. TEDDY Network provided its contribution to the...
FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
The Food and Drug Administration (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19....