Search results with tag "Periodic benefit risk evaluation report"
ICH E2C(R2) PERIODIC BENEFIT-RISK EVALUATION …
www.jpma.or.jpich e2c(r2) periodic benefit-risk evaluation report (pbrer) （定期的ベネフィット・リスク評価報告） 厚生労働省 医薬食品局 安全対策課
E2C (R2) Step 5 Periodic benefit-risk evaluation report ...
www.ema.europa.euefficiency by decreasing the duplication of effort required for the preparation of various regulatory documents. This guideline has been developed, therefore, such that corresponding sections of the PBRER, DSUR (ICH E2F), and safety specification of a risk management pl an (ICH E2E) can be identical in content.
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 ...