The European Medicines Agency (EMA) has recommended a conditional marketing authorisation in the European Union (EU) for Tecvayli (teclistamab), a monoclonal antibody […]
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In the months of May and June 2022, the European Medicines Agency (EMA) recommended granting various forms of marketing authorisation […]
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The European Medicines Agency (EMA) is organising a joint EMA/HMA/TEHDAS Data Quality Framework for Medicines workshop as a virtual meeting on […]
Read MoreIn October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced a pilot project to support the repurposing of […]
Read MoreThe European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) has gone live as of January 31st. CTIS is the […]
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The European Medicines Agency (EMA) is organising a virtual event on “Research in regulatory science – addressing the needs” to […]
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are launching a pilot project to support the repurposing of […]
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Based on evidence from a single-arm clinical trial, the European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European […]
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The Big Data Steering Group has launched an initiative to develop a Data Standards Strategy that will enable the Network to more […]
Read MoreThe way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation […]
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