{"id":27107,"date":"2026-07-21T10:56:36","date_gmt":"2026-07-21T08:56:36","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/la-farmacovigilanza-entra-nellera-predittiva\/"},"modified":"2026-07-21T11:10:27","modified_gmt":"2026-07-21T09:10:27","slug":"la-farmacovigilanza-entra-nellera-predittiva","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/regulatory\/pharmacovigilance\/la-farmacovigilanza-entra-nellera-predittiva\/","title":{"rendered":"Pharmacovigilance enters the predictive era"},"content":{"rendered":"

Pharmacovigilance<\/strong> is undergoing a transformation involving science, regulation, technology and organisational models. The growing availability of data, the introduction of artificial intelligence into operational processes, the development of advanced therapies and evolving regulatory expectations are broadening the scope of activities dedicated to medicine safety<\/strong>.<\/p>\n

This is the context for the tenth edition of the European Pharmacovigilance Congress<\/strong>, organised by Pharma Education Center. The event will follow a hybrid format, with virtual sessions on 18 and 19 November 2026<\/strong>, followed by the in-person programme on 3 and 4 December<\/strong> at the NH Milano Congress Centre. The first day in Milan will conclude with a networking aperitif and specialist workshops.<\/p>\n

The programme includes 27 topics, 24 round tables, seven virtual parallel sessions, one keynote lecture and three face-to-face workshops. Speakers will represent regulatory authorities, international organisations, the pharmaceutical industry, academia and patient associations. The previous edition brought together 645 participants from 143 companies, 50 countries and five continents.<\/p>\n

MakingLife is taking part in the 2026 edition as a media partner<\/strong>.<\/p>\n

Iscriviti Register for the Congress<\/span><\/a><\/p>\n

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From surveillance to risk prediction<\/h2>\n

One of the main themes running through the congress will be the shift from predominantly reactive pharmacovigilance towards a safety science increasingly able to anticipate risks<\/strong>. This approach emerges from the first sessions, dedicated to safety during clinical development, from first-in-human studies through to the marketing authorisation application.<\/p>\n

The safety profile of an investigational medicine is built progressively. The ability to integrate non-clinical data, signals emerging from clinical trials, pharmacological knowledge and information about exposed populations is therefore essential to support decisions throughout development.<\/p>\n

A dedicated session will explore translational safety<\/strong>, including the use of artificial intelligence, real-world evidence and New Approach Methodologies. The aim is to create stronger links between evidence generated in vitro and outcomes observed in humans, supporting risk strategies based on prediction and prevention.<\/p>\n

This perspective extends to precision safety, which seeks to understand why the same treatment may produce different risk profiles in different patients. Biomarkers, clinical data and knowledge of biological mechanisms may help identify more vulnerable individuals at an earlier stage and support more targeted risk-minimisation measures.<\/p>\n

Artificial intelligence between applications and regulation<\/h2>\n

Artificial intelligence<\/strong> will occupy a prominent place in the programme, with separate sessions devoted to regulatory requirements and practical applications.<\/p>\n

The discussion will involve representatives from the FDA, AEMPS and MHRA and will examine the conditions required to introduce AI systems into pharmacovigilance processes while maintaining control, transparency and reliability. The issue goes beyond algorithm performance. Companies must be able to demonstrate the quality of the data used, system validation, output traceability and the effective presence of human oversight.<\/p>\n

The regulatory perspective will be complemented by operational case studies covering multimodal pharmacovigilance, process interoperability and the use of AI agents in case intake. A further session will examine the use of large language models in the initial management of safety reports.<\/p>\n

The programme makes an important distinction between automating individual activities and redesigning entire processes. Applying an algorithm to an existing procedure may shorten certain processing times, but it does not automatically improve the system as a whole. The interactions between technology, operators, information systems, quality controls and decision-making responsibilities must also be considered.<\/p>\n

This dimension will be explored further during the workshop on the human\u2013machine interface in pharmacovigilance<\/strong>, dedicated to the integration of technological capabilities and human supervision. A system can only be considered fit for purpose when it functions effectively within its operational environment, supporting professionals without making the criteria used to generate an output opaque.<\/p>\n

The value of real-world data<\/h2>\n

The growing availability of health data is strengthening the role of pharmacoepidemiology and real-world evidence in safety assessment.<\/p>\n

Electronic health records, registries, administrative databases and other observational sources make it possible to study broader and more diverse populations than those usually included in clinical trials. These data may help identify signals, quantify risks, characterise patient subgroups and assess the effectiveness of risk-minimisation measures.<\/p>\n

The congress will examine the entire pathway from data to regulatory decision-making. A larger volume of information does not remove challenges related to quality, representativeness and interpretation. Bias, missing data, differences between healthcare systems and limited interoperability may all weaken the reliability of the conclusions.<\/p>\n

A round table involving members of the EMA Pharmacovigilance Risk Assessment Committee will focus on the combined use of AI, real-world data and real-world evidence in signal detection and management. The discussion will also address the limitations of these tools and the conditions required for analytical innovation to generate evidence that regulators can use.<\/p>\n

Another emerging topic will be synthetic data<\/strong>, artificially generated to reproduce the statistical characteristics of real datasets. In pharmacovigilance, they could facilitate information sharing, model development and the testing of new solutions while reducing some privacy-related concerns. Questions nevertheless remain regarding representativeness, the risk of introducing bias and regulatory acceptability.<\/p>\n

New therapies and new responsibilities<\/h2>\n

The evolution of medicinal products is also making benefit\u2013risk assessment more complex. Gene therapies, antisense oligonucleotides and other advanced therapy medicinal products present specific challenges related to small patient populations, long-lasting effects and the need for extended monitoring.<\/p>\n

A dedicated session will address the safety of gene therapies and medicines for rare diseases, with particular attention to predicting liver injury and long-term surveillance. Another discussion will focus on risk-management systems for treatments administered only once but potentially associated with effects lasting many years.<\/p>\n

The congress will also examine safety in early access and compassionate-use programmes. These pathways allow patients with serious conditions to receive promising treatments before formal authorisation, but require robust procedures for collecting reports, evaluating cases and communicating safety information promptly.<\/p>\n

A separate session will be devoted to combination products. The presence of both a medicinal product and a medical device may create two vigilance systems with different responsibilities, information flows and regulatory counterparts. Safety therefore depends on collaboration between pharmacovigilance, quality, regulatory affairs, device manufacturers and notified bodies.<\/p>\n

An increasingly global regulatory environment<\/h2>\n

Companies operating across multiple markets must manage a fragmented and continually evolving regulatory landscape. The programme will examine pharmacovigilance requirements in Africa, Asia, the United Kingdom and Latin America, with contributions focusing on Rwanda, Egypt, Japan, Brazil and other LATAM countries.<\/p>\n

Although many core principles have been harmonised, differences remain in reporting timelines, event classification, periodic documentation and local responsibilities. Integrating these requirements into a global system is one of the main operational challenges facing pharmacovigilance departments.<\/p>\n

The topic will also be addressed in a workshop on Gulf Cooperation Council countries, in light of changes to Saudi guidelines and the introduction of new national obligations across the region.<\/p>\n

From a European perspective, the congress will cover updates from CIOMS, developments in Good Pharmacovigilance Practices<\/strong> and the impact of Commission Implementing Regulation (EU) 2025\/1466<\/strong>. One workshop will examine lessons learned after its first year of application, with particular attention to signal management, EudraVigilance monitoring, risk-based audits and oversight of outsourced activities.<\/p>\n

Patients, the environment and the expanding scope of vigilance<\/h2>\n

Contemporary pharmacovigilance is also broadening the sources and subjects of its observation. One session will be dedicated to the patient perspective and to the contribution that lived experience can make to understanding the benefits and risks of medicines.<\/p>\n

The involvement of patient associations and patient experts may help identify effects that are difficult to capture through clinical classifications alone, assess the impact of adverse reactions on daily life and improve the communication of safety measures.<\/p>\n

The programme will also cover cosmetovigilance, the safety of nutraceutical products and ecopharmacovigilance. The latter examines the environmental effects of medicines across their life cycle, as well as initiatives developed to monitor their presence and impact on ecosystems.<\/p>\n

As in previous editions, the congress will close with a session devoted to audits and inspections. The discussion will focus on the inspection readiness of outsourced activities, oversight of service providers and the preparation of pharmacovigilance systems for regulatory inspections.<\/p>\n

The programme of the European Pharmacovigilance Congress reflects a discipline that is becoming increasingly integrated with clinical development, regulatory affairs, quality, epidemiology, digital technologies and environmental sciences. This transformation requires new tools and a stronger ability to connect data, responsibilities and decisions throughout the medicine life cycle.<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Pharmacovigilance Congress 2026 will take place online on 18\u201319 November and in Milan on 3\u20134 December. The programme will cover artificial intelligence, real-world evidence, advanced therapies, international regulation, device safety and risk management. MakingLife is a media partner of the event.<\/p>\n","protected":false},"author":32,"featured_media":27105,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[804,819],"tags":[],"class_list":{"0":"post-27107","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-events","8":"category-pharmacovigilance"},"yoast_head":"\nPharmacovigilance enters the predictive era - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"The European Pharmacovigilance Congress returns in November and December, focusing on AI, RWE, advanced therapies and risk management.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/makingpharmaindustry.it\/en\/regulatory\/pharmacovigilance\/la-farmacovigilanza-entra-nellera-predittiva\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance enters the predictive era - 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