News & Events
EMA: Promoting high-quality clinical research in children through strengthened international collaboration
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take place at the premises of the European Medicines Agency (EMA), is to bring relevant stakeholders together to discuss requirements, barriers and opportunities […]
RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. https://www.raps.org/News-and-Articles/News-Articles/2022/10/FDA-finalizes-multiple-endpoints-guidance
RAPS: UK on Brexit Implications: “Significant Benefits” to Remain Part of EMA
The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).
EMA: Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease
The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease’, in order to take into account issues identified since the guideline came into effect and experience gained […]