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EMA opens consultations on confirmatory...

The European Medicines Agency (EMA) has opened...

EMA opens consultations on confirmatory platform trials and pharmacovigilance data quality

The European Medicines Agency (EMA) has opened two public consultations on the methodology of confirmatory platform trials and the quality of adverse drug reaction (ADR) reporting data. The consultation deadlines are 31 January 2027 and 14 December 2026, respectively. Draft reflection paper addresses confirmatory platform trials The draft reflection paper on methodological aspects in confirmatory platform trials was published for consultation on 19 October 2026. It aims to complement existing guidance on multiplicity and adaptive trial designs, rather than replace or revise current guidance. Platform trials allow multiple treatments to be evaluated...

EMA opens consultations...

The European Medicines Agency (EMA) has opened two public consultations on the methodology of confirmatory platform trials and the quality of adverse drug reaction...
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