Dublin, May 28, 2024 (GLOBE NEWSWIRE) -- The "PSUR/PBRER Online Training - Professional Training Program on Developing, Managing and Reporting of PSURs/PBRERs in Pharmacovigilance" training has been ...
Health ministry issues draft amendment on PSUR reporting period norms under NDCT Rules: Gireesh Babu, New Delhi The Union health ministry ...
Mandatory use of the periodic safety update report repository becomes mandatory on June 13. The European Union’s (EU) PSUR repository becomes mandatory on June 13, 2016. The single, central platform ...
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has recommended amendment of the New Drugs and Clinical Trials (NDCT) Rules, 2019 to mandate submission of periodic safety update ...
From 13 June 2016 onward, companies across Europe will no longer submit periodic safety update reports (PSUR) to national regulators but instead to a central repository at the European Medicines ...
The US Food and Drug Administration (FDA) today released a new draft guidance on how to provide regulators with periodic safety reports using a format developed by the International Conference on ...
India’s drug regulator has directed pharmaceutical manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date the product is actually marketed, rather ...
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