- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
Local Qualified Persons for Pharmacovigilance (LQPPVs) are pivotal in maintaining a compliant, effective, and safe, country-specific pharmacovigilance system.
The position of Local Qualified Person for Pharmacovigilance (LQPPV) is mandated by regulatory authorities to oversee the pharmacovigilance systems within a specific country or region and is based on regulatory frameworks like the European Union’s Directive 2001/83/EC and Regulation (EC) No 726/2004, as well as guidelines from the International Council for Harmonisation (ICH), particularly ICH E2E.
The LQPPV role is therefore critical for protecting public health, ensuring that medicinal products are safe and effective throughout their lifecycle by closely monitoring and managing the risks associated with them.
The title "Local Qualified Person Responsible for Pharmacovigilance" is commonly used in the European Union, but variations or equivalent roles exist in other legislations with similar responsibilities, such as:
Collecting, evaluating, and reporting Adverse Drug Reactions (ADRs) to the relevant regulatory authorities, with follow-ups as required.
Monitoring regulatory authority websites to assess any relevant changes to local PV/Regulatory legislation.
Implementing Risk Management strategies to identify, assess, minimize, and communicate risks associated with pharmaceutical products (Direct Healthcare Professional Communications (DHPCs), assistance with the translation, revision, and submission of local educational materials, etc.).
Ensuring all pharmacovigilance activities comply with local regulations and guidelines.
Monitoring drug safety data to detect any potential safety signals or trends.
Acting as the primary contact point for pharmacovigilance requests including documentation and communications with local regulatory authorities.
Handling all Product Quality Complaints (PQCs), and Medical Information Enquiries (MIEs).
Ensuring all personal data in pharmacovigilance documents meets applicable regional and national regulations.
Supporting audits and inspections as required.
iVigee is a world leader in local pharmacovigilance, combining global expertise, local knowledge, and the latest in Regulatory Intelligence technology.
We have an extensive network of Local QPPVs or Local PV Persons in 120+ countries across the world and for each one we also nominate a deputy to ensure business continuity. We also have dedicated iViNetwork Managers to ensure a tailored solution for each client.
Our Local QPPVs and Local PV persons are already recruited and contracted, enabling us to deploy a complete local pharmacovigilance service within two months on average, during which we prepare all client-specific documentation and notify local regulatory agencies of the local QPPV or Local PV Person who will be in place.
Regulatory Intelligence collected from our Local QPPVs, and Local PV persons is validated and published in our iViReg knowledge management center, providing a comprehensive and up to date system that provides real, actionable insights into local level legislative change and its potential impacts.
And our Local Literature Monitoring service searches for case reports and relevant safety information according to the agreed journal review selectin and strategy.
iVigee provides a dedicated, efficient, and rigorous approach to your local pharmacovigilance needs. Our dedicated team, with its in-depth training and years of experience, offers unrivalled support and advice for changing regulations, making us a preferred partner in the industry.
