Medical Information
Understanding PADER: A Key Pharmacovigilance Requirement for the US 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...
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...