The debate session at the ESTIV2024 Congress, scheduled for Wednesday, June 5 from 15:00 to 16:00, focuses on the future of the validation process. This session aims to delve into the recent developments and sustainability of concepts surrounding validation studies. It promises an engaging dialogue among experts from various sectors, including industry professionals, regulatory authorities, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM), and non-governmental organizations (NGOs).

This discussion is particularly significant because it addresses the evolving landscape of validation studies, which are fundamental to the acceptance and implementation of new methodologies in toxicology and safety assessment. The debate is expected to cover a range of topics, including:

• Current Status: Assessing the present state of validation processes and their alignment with scientific advancements and regulatory requirements.
• Challenges and Opportunities: Identifying key challenges faced in validation studies and exploring opportunities for improvement and innovation.
• Sustainability: Discussing the sustainability of current validation concepts, considering factors such as technological advancements, regulatory acceptance, and the need for flexibility in the validation framework.
• Collaboration and Harmonization: Emphasizing the importance of collaboration among stakeholders from different sectors and the potential for harmonizing validation standards and practices across regions and disciplines.
• Future Directions: Speculating on future directions for validation processes, including the integration of novel technologies, computational models, and non-animal testing methodologies.

This session represents a vital platform for stakeholders from across the toxicology and safety assessment community to share insights, debate, and collaboratively shape the future of validation studies. The outcomes of this discussion could have significant implications for the development, acceptance, and application of new approach methodologies (NAMs) and other innovative techniques in the field.

The panel’s composition, featuring representatives from industry, regulatory bodies, EURL-ECVAM, and NGOs, ensures a comprehensive perspective on the validation process, encompassing scientific, regulatory, ethical, and practical considerations. This diversity of viewpoints is crucial for addressing the complex challenges associated with validating new toxicological methods and ensuring they meet the high standards required for regulatory acceptance and real-world application.

Participants and attendees can look forward to a rich exchange of ideas and perspectives, contributing to a deeper understanding of the current landscape and future potential of validation studies in toxicology. This session underscores the ESTIV2024 Congress’s role as a leading forum for advancing the discourse on critical issues at the intersection of science, regulation, and ethical considerations in toxicology.