Search results with tag "Periodic safety"
Pharmacovigilance and Risk Management - Elsevier
www.elsevier.comAggregate data are systematically analyzed for safety issues and assessed for benefit versus risk, and periodic safety update reports (PSURs) are submitted to the regulatory authorities as additional safety information is collected. This continues throughout the product’s life cycle. Safety findings are addressed in order to mitigate risk.
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euVII.A. Introduction . Periodic safety update reports ( PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation
Post-marketing Surveillance of Drugs - JPMA
www.jpma.or.jp74 medicine products; 2014 MHLW Ordinance No. 90, dated July 30, 2014). Based on the Guidelines, Periodic Safety Update Reports (PSUR) …
PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)
database.ich.orgThe ICH Guideline E2C, Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, achieved Step 4 in 1996, and was intended to harmonise the periodic reporting requirements to regulatory authorities and to provide, in a common format, the worldwide interval safety experience of a medicinal product at defined times post ...