PSUR definition
Examples of PSUR in a sentence
The Licensee is responsible for submitting the PSUR to its Authorities after adding the recent Territory data according to the requirements of the applicable laws and regulations in such countries.
The PSUR will be issued at least every [ * ] upon renewal of the marketing authorization in the respective Territory, but will comply with all reporting requirements stated above.
Distributor shall be responsible for providing on a timely basis all necessary documentation needed for all regulatory filings relating to the Marketing of the Product in the Territory with the Regulatory Authority, including all pharmacovigilance data needed for PSUR.
The PSUR will be prepared according to the timelines required in the EU or as requested by the Competent Authority in the territory.
X Periodic Safety Update Report PSURs (Production) Vifor is responsible for the preparation of the PSUR in ICH format.
If the Distributor has submitted late a PSUR to the local Competent Authority, this must be reported to VIFOR together with an explanation explaining the lateness of the submission and any corrective or preventive action (CAPA) planned or taken.
CMS shall request the PSUR from NORGINE at least SEVENTY (70) Days in advance of the Data Lock Point (“DLP”).
Until the NDA Transfer Date, Depomed shall report Adverse Drug Experience Reports, Periodic Adverse Drug Experience Reports (PADER) and Periodic Safety Update Reports (PSUR) in accordance with International Conference on Harmonization Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (ICH E2C) and 21 C.F.R. § 314.80.
This document shall be reviewed and updated regularly by GW and reviewed at least at the time of each PSUR and following detection of any new signals.
The PSUR is a practical and achievable mechanism for summarizing interval safety data, especially covering short periods (e.g., 6 months or 1 year), and for conducting an overall safety evaluation.