EU To Tighten Up Some Pharmacovigilance Requirements
Master File & Adverse Event Reporting In The Spotlight
The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.
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Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.
New recommendations could result in more effective prescribing and fewer adverse events.
Coronavirus Notebook: UK Rolls Out Ronapreve To Hospitalized Patients, Drug Safety Unit Reviews mRNA Vaccine Heart Inflammation Link
Pressure is growing on richer countries to share their excess vaccine doses, and the European Parliament has passed legislation intended to strengthen the EU’s health security framework and make joint vaccine procurement more transparent.