The third session of the regulatory training series took place on 27 May 2025, focusing on “Key Aspects of Chemistry, Manufacturing and Controls (CMC) for Small Molecules and Biologics in Europe”. Organised by Navarra Health Cluster and Asphalion, the event brought together 22 participants from 7 different organisations to explore the regulatory challenges in biopharmaceutical and healthcare innovation.
During the session, key topics were covered, including the development and registration of medicinal products, emphasising the importance of safety, efficacy, and quality at every stage of the product lifecycle. Additionally, the EU regulatory frameworks for small molecules and biological products were presented, along with the ICH guidelines and the structure of the Common Technical Document (CTD).
The topics covered included an introduction to the key regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for small molecules and biologics in Europe. The session also addressed the structure and content of Modules 2.3 and 3 of the Common Technical Document (CTD), which are essential for the development and registration of medicinal products.
The active participation and knowledge exchange among attendees reflect our community’s commitment to excellence in regulation and the advancement of innovation in the healthcare sector. Participants had the opportunity to discuss and share experiences on best practices and strategies to meet regulatory requirements and ensure success in the development of new products.
This third session of the regulatory series was a resounding success, providing valuable insights and fostering collaboration among industry professionals. We look forward with great anticipation to the upcoming sessions, which will continue to address essential topics in biopharmaceutical and healthcare regulation and innovation.
Interested in healthcare regulation topics? Don’t miss our upcoming sessions: Agenda • Navarra Health Cluster
