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PV Regulatory Intelligence and its Growing Importance

Pharmacovigilance (PV) Regulatory Intelligence is the activity of gathering, summarising and interpreting available regulatory information relating to pharmacovigilance requirements. Its fundamental goal is to keep up to date and operate in line with the latest PV requirements implemented by governments and competent authorities. PV regulatory intelligence is a critical activity for any clinical trial Sponsor or medicinal product Marketing Authorisation Holder. It helps ensure product and patient safety compliance while developing or commercialising medicinal products or medical devices. Due to ever-changing legislation and guidelines, all safety-related changes must be continuously monitored and evaluated for potential impact on the PV system…

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