- Pharmacovigilance
- Adverse Event Reporting Across Clinical Trials and Post-Market
- Comprehensive ICSR Management for Global Compliance
- Proactive Signal Detection and Risk Management in Drug Safety
- Pharmacovigilance Gap Analysis: Strengthening Your Compliance Framework
- Post-Market Surveillance: Ensuring Ongoing Drug Safety
- Literature Surveillance for Pharmacovigilance: Tracking Emerging Risks
- Preparing for Pharmacovigilance Audits: Best Practices for Compliance
- Internal Pharmacovigilance Audits: Ensuring Regulatory Readiness
- The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance
- Meeting European Pharmacovigilance Standards with QPPV Oversight
- Observational Studies and Real-World Evidence in Drug Safety
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Meeting European Pharmacovigilance Standards with QPPV Oversight
Why is QPPV Oversight Required?
The role of the QPPV is a mandatory regulatory requirement for any company that markets pharmaceuticals in the EU. This is outlined under EU pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). These regulations require that the company designates a QPPV who is responsible for ensuring that the company meets all pharmacovigilance obligations.
Specific Requirements for QPPV Involvement:
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Pharmacovigilance System Master File (PSMF): The QPPV must maintain and update the PSMF, ensuring that it reflects the current state of the company’s pharmacovigilance system. This document must be readily accessible to regulatory authorities during audits or inspections.
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Risk Management Plans (RMPs): The QPPV must oversee the creation and implementation of Risk Management Plans for each marketed product, ensuring that risks are monitored and mitigated according to EU standards.
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Periodic Safety Update Reports (PSURs): The QPPV is responsible for the submission of PSURs, which provide a comprehensive evaluation of the product’s risk-benefit profile during its lifecycle. Timely submission is essential to maintaining compliance.
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Safety Data Submission: The QPPV ensures that all relevant safety data, including ICSRs and safety signals, are submitted to the EudraVigilance database, which collects and manages information on adverse drug reactions in the EU.
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Ongoing Safety Monitoring: Continuous monitoring of the product's safety profile is required. The QPPV must oversee signal detection and risk assessment activities to ensure that any new risks are promptly identified and reported.
Ensuring Compliance through QPPV Oversight
A QPPV plays a central role in ensuring compliance with European pharmacovigilance standards. Companies without a qualified QPPV or with gaps in their pharmacovigilance system can face significant regulatory penalties, including fines, product recalls, or loss of market authorization. Viltis provides outsourced QPPV services to help companies meet these regulatory demands while ensuring drug safety and compliance.
Conclusion:
By leveraging the expertise of a Qualified Person for Pharmacovigilance (QPPV), pharmaceutical companies can ensure that their pharmacovigilance systems are compliant, efficient, and responsive to safety concerns. Whether you need a dedicated QPPV or support in managing your pharmacovigilance system, Viltis offers tailored services to help you navigate the complexities of global pharmacovigilance.