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Why Every Firm Needs A Pharmacovigilace Strategy

Why Every Firm Needs A Pharmacovigilace Strategy

Pharmacovigilance  is about continuously monitoring the safety of a drug throughout its lifecycle, from clinical trials to its widespread use by the public. 

It's a legal, regulatory and ethical obligation that underpins public trust, ensures regulatory compliance, and protects a company's most valuable asset: its reputation.

National Drug Authority’s key expectations in regards to Pharmacovigilance in Uganda include:

  • Mandatory adverse event reporting.
  • Ongoing safety monitoring post-trial.
  • Inspection ready PV systems that can be audited during NDA inspections.

Benefits of a Strong Pharmacovigilance System:

  • Builds public trust.
  • Ensures faster regulatory approvals.
  • Protects company reputation.

Firms that integrate PV from day one of trials meet NDA compliance and build long-term value and meet compliance requirements. 

By proactively making patient safety a priority, pharmaceutical companies can foster public confidence, secure faster market approvals, and ultimately, thrive in the complex global pharmaceutical landscape. 

Regulix Team
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Regulix Team

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