Скачать или смотреть (2)Periodic/Development Safety Update Report

Pharmacovigilance system – Periodic/Development Safety Update Report(2)

00:00 Intro
00:10 Format and Presentation of PBRER
00:46 Recommended table of contents for PBRER
05:27 3. Action Taken in the Reporting interval
12:10 6. Data in Summary Tabulations
13:05 7. Summaries of significant safety findings from Clinical trials
16:36 14. Late-breaking information
18:28 16. Signal and Risk Evaluation
20:55 18. Integrated benefit-risk analysis for approved indications
22:35 EMA GVP Module VII – Periodic Safety Update Report
23:24 MFDS – 정기적인 최신 안전성정보 보고
24:09 Recommended table of contents for the DSUR

Ref 1) ICH Pharmacovigilance E2C Guideline – Periodic Benefit-Risk Evaluation Report(PBRER)
Ref 2) ICH Pharmacovigilance E2F Guideline – Development Safety Update Report
Ref 3) EU GVP Module VII – Periodic Safety Update(Rev 1)
https://www.ema.europa.eu/en/document...
Ref 4) FDA Guidance for Industry – Postmarketing Safety Reporting for Human Drug and Biological Products including Vaccines
https://www.fda.gov/files/vaccines%2C...

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