What is aggregate reporting (PSUR, DSUR, PADER) in pharmacovigilance?

[sollers college]

Aggregate reporting summarizes a drug’s safety profile over time using structured reports:

• PSUR/PBRER: Periodic safety benefit-risk evaluation for marketed drugs.
• DSUR: Covers ongoing safety during clinical development.
• PADER: Used for US-specific postmarketing safety updates.

  These are key regulatory tools to ensure continued patient safety arxiv.orgfacebook.com+3en.wikipedia.org+3ccrps.org+3.

  Learning Avenues:

• Data sources and report compilation
• Regulatory frameworks and compliance expectations
• Benefit-risk interpretation

  The Aggregate Reporting module at Sollers College gives you this knowledge with hands-on training.
  Check the curriculum: http://www.sollers.college

  Topics: RegulatoryAffairs, AggregateReporting

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