The XII session of the 64th AFI Symposium, entitled “Educational Materials: Effective Management in the Digital Era,” addresses a topic of great scientific and regulatory significance: educational materials and the Risk Management Plan (RMP) as central tools for pharmacovigilance and the protection of public health. The session, coordinated by Andrea Oliva, takes place within a constantly evolving context, in which new European guidelines and emerging data require continuous updates of strategies to ensure the safe and appropriate use of medicines.
Introductory framework: the evolving landscape
Educational materials – so-called “educational tools” – represent a crucial component of modern pharmacovigilance. These materials, aimed at physicians, pharmacists, and patients, are designed to provide clear and precise information on the correct use of medicines, reducing associated risks and improving clinical management. Their importance has grown in parallel with the evolution of increasingly complex and targeted drugs.
In recent years, the revision of European regulations – with Regulation (EU) No 1235/2010 and Directive 2010/84/EU – has emphasized the shared responsibility among pharmaceutical companies, regulatory authorities, and healthcare professionals. In Italy, AIFA has updated its guidelines on educational materials, promoting a more integrated and participatory approach. The result is a system that requires constant dialogue among all stakeholders, to ensure not only regulatory compliance but also the actual effectiveness of educational materials in clinical practice.
The topic of the XII session
As explained by Andrea Oliva in the introductory video, the session will begin with a presentation by the Pharmacovigilance Health Department of AIFA, outlining the current state of pharmacovigilance in Italy. This will be followed by a presentation from the person responsible for educational materials and the Risk Management Plan, providing an update on ongoing initiatives and future challenges.
A central moment will be the review of the AFRI project, which involves drafting a shared position paper among the main stakeholders. This document aims to define harmonized guidelines for the implementation of educational materials and RMPs, in line with the new legislation and best international practices. The comparison with experiences from other countries and other stakeholders (such as pharmaceutical companies and trade associations) will help identify areas for improvement and propose concrete solutions for the Italian context.
The involvement of pharmacists and patients
The session also includes an interview with a hospital pharmacist and a representative of a patient association, aimed at exploring the relevance of educational materials in daily practice. This moment of direct exchange will highlight the specific needs of the end-users of educational materials and will allow for an analysis of potential challenges that may arise in their implementation.
The goal is twofold: on one hand, to ensure that educational materials are understandable, up-to-date, and truly useful; on the other, to guarantee that they are actually utilized by healthcare professionals and patients. The pharmacist, in particular, plays a key role in this process: thanks to their direct proximity to the patient, they can translate the contents of educational materials into practical advice, thus promoting therapeutic adherence and reducing risk.
The final roundtable: a strategic discussion
The session will close with an internal roundtable featuring representatives from the pharmaceutical industry, health authorities, and other stakeholders. The focus will be on analyzing the impact of the new educational materials and risk management strategies, with the goal of identifying virtuous collaboration models.
The discussion will address the importance of shared and transparent processes that can leverage the expertise of each participant and foster more effective risk management. Indeed, open dialogue between companies, regulatory authorities, and associations is one of the keys to the success of any pharmacovigilance initiative, especially in a regulatory and scientific context that is constantly evolving.
Future challenges: from Plan to Practice
As Oliva highlighted, the session offers a valuable opportunity to discuss the new Risk Management Plans and recently released educational materials. In Italy, in fact, the revision of these tools is underway and represents a priority for AIFA and the entire pharmaceutical sector.
The main challenges concern the ability to:
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ensure consistency between educational materials and the characteristics of each product,
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guarantee clarity and accessibility of information for different target audiences,
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monitor the actual use of educational materials and their effectiveness,
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collect real-world data on the impact of educational activities on prescribing behaviors and therapeutic adherence.
These elements require a systematic approach, based on robust data and continuous dialogue with those working in the field. In this sense, the experience of the AFRI project and the collaboration with the AIRAE group offer a concrete example of how sharing expertise and responsibilities can translate into real improvements in patient safety.
Join the session
Educational materials are no longer just informational tools; they have become strategic levers to ensure the safe and appropriate use of medicines. The dialogue among health authorities, the pharmaceutical industry, pharmacists, and patient associations—at the heart of the session—forms the foundation for a concrete and sustainable evolution. In this context, the commitment of all stakeholders will be crucial in transforming regulatory indications into effective actions that can improve public health and the quality of care.