Navarra Health Cluster and its member entity Asphalion organised the fourth specialised training session within their series on regulatory challenges, entitled “Nonclinical and Clinical Development: From Discovery to Market for Small Molecules and Biologics in Europe.”
This session, held on 1 July 2025 at the CEIN auditorium, was led by Marta Rayo Lunar, Director of Scientific and Regulatory Affairs at Asphalion.
The training session was attended by 20 participants from 10 different organisations, including Asphalion, CIMA, Geiser Pharma, InnoUp Farma, Nanogrow Biotech, Navarrabiomed, la Universidad de Navarra, Telum Therapeutics, Trimerbody Pharma.
During the session, participants had the opportunity to delve into the essential aspects of nonclinical and clinical development of small molecules and biologics. The importance of a robust nonclinical strategy as a foundation for successful clinical development was highlighted, addressing the critical development phases and the regulatory expectations at both European and international levels.
In addition, the session explored the guidelines and regulations governing nonclinical and clinical development, focusing on how to meet regulatory requirements, accelerate approval timelines, and leverage innovation in the pharmaceutical sector. Participants also learned about the implementation of data management systems and the preparation of regulatory dossiers, as well as the importance of pharmacovigilance and drug safety during clinical trials.
Finally, the training included a review of case studies and practical examples that illustrated how to apply the knowledge gained in real-life situations. Attendees left the session with a deeper understanding of the steps required to bring a therapy from discovery to market, along with practical tools to enhance their ability to meet regulatory requirements and foster innovation in drug development.
Interested in healthcare regulation topics? Don’t miss our upcoming sessions: Agenda • Navarra Health Cluster
