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Medical Information

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Pharmacovigilance is a global responsibility, and regulatory requirements may differ significantly depending on the region. One such region-specific requirement is the Periodic Adverse Drug...

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Pharmacovigilance

Understanding the PSUR and PBRER

Periodic Safety Update Reports (PSURs) play a pivotal role in ensuring the ongoing safety and efficacy of medicinal products once they've entered the market. While initial clinical trials provide...