
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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