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Open in new tab Understanding Pharmacovigilance Compliance for MAH and Sponsors : The Global Pharmacovigilance strategy for US, UK, EU, TGA and APAC!
Achieving full Pharmacovigilance Compliance is a top priority for every MAH and Sponsor navigating the pathway from SDEA to PSMF. As regulatory landscapes evolve globally, maintaining a robust safety system is not just a legal requirement but a commitment to patient safety.
The Role of SDEA in Compliance
A Safety Data Exchange Agreement (SDEA) is the foundation of any partnership between an MAH and its vendors. Without a clear SDEA, Pharmacovigilance Compliance becomes impossible to track. It defines who is responsible for reporting, timelines for ICSRs, and the quality of safety data.
Moving from SDEA to PSMF
The Pharmacovigilance System Master File (PSMF) is the “bible” of your safety operations. To maintain Pharmacovigilance Compliance, your PSMF must be a living document that accurately reflects your current global strategy.
5 Key Pillars of Global PV Compliance:
Signal Detection: Proactively identifying risks before they become crises.
Quality Management: Ensuring every ICSR is accurate and timely.
Vendor Oversight: Rigorous due diligence for all outsourced activities.
Audit Readiness: Being prepared for regulatory inspections at any moment.
Regulatory Intelligence: Keeping up with US, EU, and APAC regional changes.
Conclusion
Investing in Pharmacovigilance Compliance today saves your organization from the heavy penalties of non-compliance tomorrow.
At Global Placo Solutions, we specialize in bridging the gap between clinical operations and global regulatory expectations.