Articol
Adopting a strategic approach to managing PV activities for the mature portfolio
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Monica Buchberger
As the next major pharma patent cliff looms, putting between $200 billion and $350 billion of revenue at risk1, companies are assessing how best to maintain at least some profitability level from their mature product portfolios. To mitigate these losses, proactive companies employ a wide range of strategies to manage the mature product portfolio in the most budget- and resource-efficient way.
One approach many adopt is to work with outsourcing partners to support the regulatory (RA), pharmacovigilance (PV), and quality activities (QA) that are crucial to keeping the product on global markets while reducing the product maintenance costs involved.
One approach many adopt is to work with outsourcing partners to support the regulatory (RA), pharmacovigilance (PV), and quality activities (QA) that are crucial to keeping the product on global markets while reducing the product maintenance costs involved.
Thinking global, acting local with pharmacovigilance expertise
Biopharma companies must meet a wide range of PV requirements to ensure a positive risk-benefit balance and keep their products on the market – from signal management to preparing individual case safety reports (ICSR) to carrying out aggregate safety reports to managing the safety database to specific biopharma pharmacovigilance requirements and carrying out local affiliate services.
Additionally, companies with products on the market in Europe must follow dedicated European pharmacovigilance regulations, e.g. they must have fully compliant and functional PV systems, overseen by a Qualified Person for Pharmacovigilance (QPPV).2
Rather than having full-time personnel on the ground in multiple global markets, companies often turn to outsourcing partners to support crucial regulatory and safety activities from a central hub, while also ensuring on-the-ground support for local activities.
Additionally, companies with products on the market in Europe must follow dedicated European pharmacovigilance regulations, e.g. they must have fully compliant and functional PV systems, overseen by a Qualified Person for Pharmacovigilance (QPPV).2
Rather than having full-time personnel on the ground in multiple global markets, companies often turn to outsourcing partners to support crucial regulatory and safety activities from a central hub, while also ensuring on-the-ground support for local activities.
Not only does this reduce costs of maintaining a full-time workforce in multiple markets, but it also addresses the increasingly difficult challenge of finding the right PV expertise needed for each country in which the company has its products.
Adopting a harmonized, forward-looking approach to PV
A common issue for biopharma companies is that each local office has its own way of managing processes. Outsourcing these activities to a single service provider enables a more harmonized approach, by leveraging intelligence between different countries, regions, and teams.
It also helps companies achieve strategic oversight of all pharmacovigilance responsibilities and paves the way for expanding into new markets without the need to bring on additional staff in those regions.
Another key consideration for companies is the ability to leverage digital innovation tools, such as artificial intelligence, to support key safety activities such as signal management. At the same time, however, investing in digital capabilities is cost-intensive and hard to justify for mature products. Outsourcing management of the mature portfolio, including essential PV activities, to a partner with digital capabilities and expertise gives biopharma companies access to those solutions, as and where it makes business sense.
It also helps companies achieve strategic oversight of all pharmacovigilance responsibilities and paves the way for expanding into new markets without the need to bring on additional staff in those regions.
Another key consideration for companies is the ability to leverage digital innovation tools, such as artificial intelligence, to support key safety activities such as signal management. At the same time, however, investing in digital capabilities is cost-intensive and hard to justify for mature products. Outsourcing management of the mature portfolio, including essential PV activities, to a partner with digital capabilities and expertise gives biopharma companies access to those solutions, as and where it makes business sense.
Reducing complexity with an integrated PV approach
The reasons biopharma companies seek a partner to manage the essential PV activities for their mature products varies, but in all cases top priorities include compliance and operational efficiency.
In one example, a German biopharmaceutical organization needed a comprehensive outsourced solution for PV tasks for its large portfolio of marketing authorizations. Key requirements included fully outsourced pharmacovigilance system administration, including a fully validated safety database, support for all operational PV activities, and effective coordination of its worldwide network of strategic partners.
The company turned to Cencora for a PV system that would consolidate its pharmacovigilance responsibilities under a single provider, serving multi-territory needs and providing strategic oversight. The partnership resulted in reduced complexity and streamlined safety activities – from management of the PV system to end-to-end pharmacovigilance oversight to audit and inspection readiness to ongoing intelligence for all drug safety and cross-functional issues.
In one example, a German biopharmaceutical organization needed a comprehensive outsourced solution for PV tasks for its large portfolio of marketing authorizations. Key requirements included fully outsourced pharmacovigilance system administration, including a fully validated safety database, support for all operational PV activities, and effective coordination of its worldwide network of strategic partners.
The company turned to Cencora for a PV system that would consolidate its pharmacovigilance responsibilities under a single provider, serving multi-territory needs and providing strategic oversight. The partnership resulted in reduced complexity and streamlined safety activities – from management of the PV system to end-to-end pharmacovigilance oversight to audit and inspection readiness to ongoing intelligence for all drug safety and cross-functional issues.
Adopting an adaptable approach to pharmacovigilance outsourcing
As biopharma companies consider their approach to managing PV outsourcing, especially for the mature portfolio, many choose to start small and expand as needed.
For example, a U.S.-based company may seek a partner to support the QPPV requirements in Europe, leaving that partner to manage PV activities there. Alternatively, if the company has a European office to support central activities (such as the QPPV) but has no local expertise, it might seek a partner to cover local affiliate services rather than having to employ local contact personnel for each market to carry out local literature screening and perform local risk assessments, case intakes, and other local activities. As needs grow and as the portfolio matures, companies may choose to extend the outsourcing engagement to other service lines.
The emphasis is to seek support where it makes greatest strategic sense, such as where the company lacks resources to manage essential activities or where local expertise is required.
As products mature and the company’s focus shifts to new product development, the opportunity to expand the outsourcing relationship to achieve global holistic support across PV, regulatory, and quality can be leveraged – how, when and where it makes strategic business sense.
For example, a U.S.-based company may seek a partner to support the QPPV requirements in Europe, leaving that partner to manage PV activities there. Alternatively, if the company has a European office to support central activities (such as the QPPV) but has no local expertise, it might seek a partner to cover local affiliate services rather than having to employ local contact personnel for each market to carry out local literature screening and perform local risk assessments, case intakes, and other local activities. As needs grow and as the portfolio matures, companies may choose to extend the outsourcing engagement to other service lines.
The emphasis is to seek support where it makes greatest strategic sense, such as where the company lacks resources to manage essential activities or where local expertise is required.
As products mature and the company’s focus shifts to new product development, the opportunity to expand the outsourcing relationship to achieve global holistic support across PV, regulatory, and quality can be leveraged – how, when and where it makes strategic business sense.
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About the author:
Dr. Monica Buchberger is Practice Area Lead, PV System Governance, at Cencora. She has more than 25 years of experience in the pharmaceutical industry in functions with global and local accountability spanning pharmacovigilance, regulatory affairs, and quality assurance. Her key areas of focus include international pharmacovigilance and regulatory legislation, mergers/acquisitions and spin-offs (portfolio integration, divestments), setup of pharmacovigilance systems
Precizare:
Informațiile furnizate în acest articol nu constituie consultanță juridică. Cencora, Inc. încurajează insistent cititorii să revizuiască informațiile disponibile legate de subiectele discutate și să se bazeze pe propria experiență și expertiză în luarea deciziilor legate de acestea.
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Sources
1. Big Pharma race to snap up biotech assets as $170 billion patent cliff looms, CNBC, 7 January 2026. Accessed 12 March 2026. https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html
2. Pharmacovigilance system: questions and answers, EMA. Accessed 12 March 2026. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/pharmacovigilance-system-questions-answers
