Medicine shortages are not sporadic events, but signals of a system under pressure. This will be the focus of the sixth session of the 64th AFI Symposium, which sheds light on a now structural issue in pharmaceutical manufacturing: ensuring the continuous availability of essential medicines.
The phenomenon is multifactorial and steadily growing. At its core are often non-compliance with GMP or GDP standards, supply chain disruptions, over-reliance on a limited number of suppliers, weaknesses in manufacturing processes, or poorly managed changes. Any weak link can trigger a crisis that reverberates throughout the system—all the way to the patient.
The public health risk is real. Chronic, oncological, or vulnerable patients cannot afford treatment interruptions. As emphasized in the symposium, drug availability is not just an industrial matter, but a health and ethical priority.
The panel’s message is clear: the industry needs stronger quality systems, capable not only of responding to crises but of preventing them. This means adopting digital technologies, real-time monitoring systems, lean procedures, and supplier diversification strategies. Most importantly, it calls for a cross-functional, deeply rooted culture of quality.
A key focus of the discussion is the need for ongoing and transparent dialogue with regulatory authorities, such as EMA and FDA, which have been invited to contribute to the session. Timely information sharing is crucial to anticipate shortages, coordinate responses, and mitigate risks.
Another critical issue is change management. Any modification to processes or suppliers can cause delays or disruptions if not rigorously planned. Likewise, the globalization of the supply chain exposes the system to external risks: a local issue in one region can have global consequences.
Why attend?
This session aims to present a clear vision: quality, resilience, and collaboration. Companies must strengthen supply chain control, adopt global risk management approaches, and build trustworthy relationships with suppliers. At the same time, authorities must uphold high standards while also supporting flexibility and responsiveness.
In short, preventing shortages means investing in quality as a strategic lever.
It is not only a regulatory requirement but also an ethical imperative.
The session is scheduled for June 12, and it will be introduced by Alessandro Regola, Vice President of AFI. Watch the video interview: