Drug safety reporting (PSAR, DSUR)

Development Safety Update Report (DSUR) is a review of safety information during clinical trial of a drug.

DSUR should be forwarded to Roszdravnadzor by an authorized legal entity in whose name the clinical trial permit has been issued.

This has to be done within 60 calendar days from the end date of AE data collection period for the medicinal product under investigation.

Anastasija Zhigalkina

Anastasija Zhigalkina

Lead Marketing Communications Manager

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