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Ensuring safety and compliance: the essentials of outsourcing pharmacovigilance

Navigating the intricate landscape of pharmacovigilance at the affiliate level requires a strategic approach to ensure compliance, patient safety, and operational efficiency. In this blog, we delve into the rationale behind outsourcing pharmacovigilance activities at the affiliate level and explore the essential requirements for appointing local persons for pharmacovigilance (LPPVs). As we examine the potential challenges inherent in managing pharmacovigilance locally, we uncover the complexities arising from geographical diversity, streamlined processes, and oversight by marketing authorisation holder (MAH) headquarters. Furthermore, we shed light on the pivotal role LPPVs play in aligning with regulatory expectations and facilitating robust pharmacovigilance systems. Join us on this exploration of how outsourcing, standardised procedures, and strategic resource allocation can optimise affiliate pharmacovigilance activities and elevate regulatory compliance.

Requirements for local and qualified persons for pharmacovigilance

In many jurisdictions, the appointment of a LPPV is a mandatory requirement for the authorisation and launch of pharmaceutical products. The timing of this appointment may vary, occurring either at the time of application or approval. The term LPPV is more commonly used in the EU/EEA, where there is an EU qualified person responsible for pharmacovigilance (QPPV). Outside of the EU/EEA (e.g., in the UK) the LPPV is referred to as a QPPV. The legal foundation for this appointment varies across jurisdictions, encompassing expectations such as proficiency in the local language, residency, specific qualifications, notification to the Member State or local authority, 24/7 availability (with backup arrangements), and personal liability.

The LPPV assumes a pivotal role in ensuring that the MAH adheres to pharmacovigilance requirements during product launches in each country. This encompasses establishing and maintaining mechanisms, systems, and processes for the collection, reporting, and follow-up on adverse reactions. Beyond these responsibilities, the LPPV is often tasked with overseeing the local PV system, providing valuable insights into the local market, competitive landscape, and regulatory agency preferences. Serving as the primary point of contact for regulatory agencies, the LPPV bears the ultimate responsibility for ensuring safety and compliance while supporting initiatives for risk minimisation and overall success.

Potential challenges with local pharmacovigilance activities

Effectively managing pharmacovigilance activities at the local level requires careful consideration of several potential challenges. One significant obstacle is geographical diversity, where different regions may have distinct regulatory requirements and reporting mechanisms, posing a challenge in maintaining uniformity. Additionally, the lack of emphasis on local pharmacovigilance activities and the absence of streamlined processes can result in inefficiencies, hindering the timely identification and reporting of adverse events. The reduced oversight by the MAH headquarters in the pharmacovigilance activities of the local affiliate may lead to poor compliance metrics, potentially jeopardising patient safety. Failure to address and control the pharmacovigilance activities of local affiliates can result in time-consuming and costly repercussions. Moreover, the heightened likelihood of regulatory authorities inspecting a complex pharmacovigilance system adds another layer of complexity, underscoring the crucial importance of establishing robust local processes to ensure compliance and patient well-being.

The MAH bears the responsibility of ensuring that appropriately qualified LPPVs are in place, meeting the minimum requirements of the Member State/local authority and possessing adequate training and experience. Failure to fulfil this responsibility could lead to non-compliance with regulations and inspection findings. Finite resources within existing local affiliate offices of the MAH may impose limitations, potentially causing service disruptions.

A potential "silo" mentality among local affiliates may result in disparate pharmacovigilance activities and procedures, lacking a common organisational and governance framework and placing increased demands on the MAH. Establishing a set of procedures and key performance indicators (KPIs) agreed upon by each LPPV through a service provider ensures that safety responsibilities are consistently carried out in accordance with global policies. Harmonising procedures and quality standards among all LPPVs not only align pharmacovigilance processes, including risk management, but also provides access to metrics at individual, country, and global levels.

How to get the best outcome from an outsourced affiliate model

Outsourcing affiliate pharmacovigilance activities to a service provider streamlines operations by consolidating responsibilities into a single interface. This centralised approach entails the delivery of affiliate pharmacovigilance activities through a centrally managed service, fostering global harmonisation of pharmacovigilance processes. The service provider establishes a robust infrastructure leveraging a network of established LPPVs, acting as a liaison between the Member State/local authority, the MAH, and local and front-line staff, including pharmacovigilance and the medical call centre. This ensures effective communication of queries, locally generated product safety information, safety emerging issues, product recalls, and safety profile monitoring within stipulated timeframes in compliance with local regulations.

An outsourced solution offers access to readily available resources within an established LPPV network, allowing LPPVs to cover multiple projects efficiently. This strategic resourcing aligns with geographical and linguistic requirements, optimising in-country resource allocation. The outsourced model also centralises resources, enhancing efficiency and reducing costs. The single outsourced interface managing the medical information call centre team for different regions facilitates information sharing during key events of a product’s lifecycle, promoting process alignment, and providing insights on reported safety events, product complaints, and medical requests.

The outsourced provider conducts rigorous selection processes, reviewing IT security, business continuity, code of conduct, and pharmacovigilance SOPs. Transferring responsibility to the service provider ensures accountability for ongoing pharmacovigilance training throughout the partnership lifecycle with the MAH. Experienced LPPVs utilise their network to stay informed on the latest local regulations, contributing to the global pharmacovigilance system's compliance with local regulations. Additionally, the MAH gains access to an overview of local regulations from the service provider.

Financial management in an outsourced solution occurs through a single interface, consolidating multiple invoices into one transparent invoice. Leveraging the LPPV network allows for swift billing adjustments to meet evolving pharmacovigilance requirements and enables the expansion of pharmacovigilance services to new countries. The existing network's flexibility and dynamism optimise infrastructure for quick deployment of pharmacovigilance services in new countries and emerging markets. These aspects collectively lead to cost efficiencies, resource optimisation, and enhanced flexibility when deploying an outsourced solution.

An outsourced affiliate model empowers the MAH with access to skilled resources specialising in local pharmacovigilance, providing scalability, transparency, and the standardisation necessary for improved regulatory compliance and effective MAH oversight.

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