Sustainability is an increasingly relevant issue in the pharmaceutical sector, bringing new challenges and shaping an evolving regulatory landscape.
The first session of the 64th AFI Symposium opens with an overview of the latest international regulations and obligations relevant to 2024 and 2025, including the omnibus package proposed by the European Community at the beginning of 2025, which is currently awaiting approval. This regulation is expected to affect the timing and implementation of several directives. Key directives under discussion include the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CSDD), with a focus on the concept of double materiality, which evaluates both the company’s environmental and social impact and the external environmental factors that may influence its business activities.
The session will also address the updated Environmental Risk Assessment (ERA) guidelines, issued in February 2024. These introduce new methodologies for conducting environmental studies and preparing documentation required for regulatory approval during the marketing authorization process of new drugs or significant variations to existing products.
The second part of the discussion is dedicated to company-led sustainability initiatives. Chiesi Group will present their roadmap for achieving net zero greenhouse gas emissions, based on an “avoid, reduce, compensate” strategy. Similarly, GSK Group will share their progress and commitment to their net zero nature positive program, outlining methodologies and results. Angelini Pharma will introduce the Life Green AAP project, co-financed by the EU LIFE program and developed in collaboration with Leiden University. This initiative aims to innovate pharmaceutical ingredient production by transitioning from traditional batch processes to more efficient and sustainable continuous flow processes.
The session will conclude with an interactive Q&A segment, allowing participants to engage directly with experts and delve deeper into regulatory frameworks and corporate sustainability strategies.
🎥 Watch the invitation from Pierfelice Ferrari, Coordinator of the A.F.I. Study Group on Energy and Sustainability.
📅 Save the date: June 11, 2025, in Rimini.