Local Person for Pharmacovigilance (LPPV)
Local Contact Person for Pharmacovigilance services (LPPV/LCPPV) in Azerbaijan, Belarus, Georgia, Russia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Ukraine, Uzbekistan
In the ever-evolving landscape of healthcare, the importance of pharmacovigilance cannot be overstated. As the discipline dedicated to the safety monitoring of pharmaceutical products, pharmacovigilance plays a crucial role in protecting public health. At the heart of this process is the role of the Local Person for Pharmacovigilance, a pivotal figure in ensuring compliance with regulatory requirements related to drug safety.
What is Local Person for Pharmacovigilance (LPPV)?
The LPPV function also known as “Local Contact Person responsible for Pharmacovigilance” (LCPPV), “National Person Responsible for Pharmacovigilance” (NPRP), “Local PV Contact Person”, “Local Contact Person”, Local Safety Officer (LSO).
A Local Person for Pharmacovigilance (LPPV) is an individual appointed by a pharmaceutical company or their representative, local pharmacovigilance consulting services offering companies in a specific country or region. Their primary responsibility is to oversee and manage the pharmacovigilance activities required by local regulations. This includes monitoring adverse events, conducting risk assessments, and reporting findings to the relevant health authorities. The LPPV acts as the primary contact point for these activities, bridging the gap between the pharmaceutical company and the local regulatory environment.
PharmExpert LLC offers to marketing authorization holders (MAH) services on Local Person for Pharmacovigilance (LPPV). These services are provided in the territory of CIS сountries (post-Soviet states) and EEU, accordingly.
The Importance of an LPPV/LCPPV
Compliance with Regulatory Standards: Different countries have their own regulatory frameworks for pharmacovigilance. An LPPV ensures that the company’s practices align with local laws and requirements. This compliance is essential not only for maintaining market authorization but also for safeguarding patient safety.
Rapid Response to Adverse Events: In the event of adverse drug reactions or safety concerns, the LPPV is responsible for promptly collecting, assessing, and reporting these incidents. By having a dedicated LPPV, companies can ensure timely responses to potential safety issues, thereby minimizing risks to patients.
Cultural and Regional Expertise: An LPPV often possesses a deep understanding of local medical practices, cultural factors, and health trends. This insight is invaluable when assessing drug safety within the context of the local population. Their knowledge can enhance the effectiveness of pharmacovigilance activities and ensure that local concerns are appropriately addressed.
Building Relationships with Regulatory Authorities: The LPPV serves as a liaison between the pharmaceutical company and local regulatory bodies. By fostering strong relationships with these authorities, LPPVs can facilitate better communication and collaboration, ultimately leading to improved drug safety and efficacy monitoring.
Local Pharmacovigilance Activity Demo-Procedure
LPPV/LCPPV Key Roles and Responsibilities
– Performs representative functions of the LPPV, including notification of local regulatory authorities (RA) on the nomination of LPPV. Also, including registration in the database of local RAs (if applicable)
– Interacts with the local RA on behalf of the MAH/Third party in the Territory
– Keeps both accounting and reconciliation with MAH/Third party on received and submitted to the RA cases of adverse reactions (AR).
– Performs continuous monitoring of the safety lines, including 24/7 availability of the LPPV for RA and receiving information from the MAH/Third party
– Informs the MAH/Third party on the safety information received through the safety data monitoring channels (e.g., literature and internet sources, ICSRs safety databases of local RA, project specific mailbox, etc.) within required timeframes
– Performs regulatory intelligence and monitoring of updates pertaining to pharmacovigilance in the Territory
– Performs and documents monitoring of local literature and Internet resources in the Territory on a weekly basis to search for safety information. Furthermore providing the results of local literature monitoring to the MAH/Third party
– Translation ICSRs and/or other safety information from the local language into English (if required)
– Performs and collects follow up information on AE/AR cases (upon the request of MAH/Third party)
– Submits the ICSR/PSUR/DSUR to the local RA (upon request of MAH/Third party) in accordance with the local regulatory requirements of the Territory, documents the procedure and as well as provides the MAH/Third party with acknowledgement of successful submission
– Fulfills and documents safety information requests in RA’s database, transfer of the received data to the MAH/Third party with translation into English (if applicable)
– In close cooperation with MAH/Third party participates in the preparation of responses to requests from the RAs and submits the responses agreed with the MAH/Third party to the RAs
– Communicates with the MAH/Third party on issues that require immediate resolution regarding the medicinal products’ safety in the Territory
– Participates in teleconferences with the MAH/Third party (upon request)
– Completes and documents the results of training in accordance with the standard operating procedures of PharmExpert LLC, including trainings on the pharmacovigilance system and the safety profile of medicinal products of the MAH
– Participates in audits by the MAH/Third party and inspections by the RA as the auditee (upon request)
– Participates in the preparation and implementation of correction and corrective actions if nonconformities happen (upon request)
– Performs ad hoc pharmacovigilance activities (e.g., review of pharmacovigilance documentation), implementation of additional risk minimization measures)
– Handling of medical enquiries
– Other drug safety related tasks (upon request).
LPPV/LCPPV Qualification Requirements
- Medical/pharmaceutical education or higher education in biostatistics (university degree)
- 1 year + of pharmacovigilance experience in both clinical and post-marketing supervision.
The Future of LPPV/LCPPV in Pharmacovigilance
As the pharmaceutical industry continues to grow and evolve, so too will the role of the LPPV. Advances in technology, particularly in data analytics and real-time monitoring, are reshaping how pharmacovigilance is conducted. LPPVs will need to adapt to these changes, leveraging new tools and methodologies to enhance their effectiveness.
Furthermore, the growing emphasis on patient-centered care and the integration of real-world evidence into clinical decision-making will require LPPVs to engage more closely with patients and healthcare providers. Building trust and transparency will be essential in achieving the goal of optimal patient safety.
The role of a Local Person for Pharmacovigilance is critical in maintaining the integrity and safety of pharmaceuticals in a global marketplace. By ensuring compliance with local regulations, fostering relationships with regulatory authorities, and promoting awareness of drug safety, LPPVs are instrumental in protecting public health. As the industry evolves, so too will the responsibilities and importance of LPPVs, making them an integral part of the pharmacovigilance landscape.
