Upcoming Events

Discover the key regulatory updates, technical differences, and best practices for implementing eCTD v4 in Japan. From navigating Japan-specific adaptations to mastering efficient submission workflows, this session equips life sciences companies with the insights they need to succeed.

EMA's move toward eCTD v4 is shaping the future of agency and industry alike. Learn the core concepts of the eCTD v4 model, explore the EMA’s approach, and gain valuable insights from eCTD v4 pilot projects.

Our new ePI Masterclass series kicks off with Anjana Pindoria-Rettenberger leading an insightful opening session. With the EU Pharma Package, electronic Patient Information (ePI) is moving from vision to reality and soon it will be mandatory across Europe. In Part I, Anjana sets the scene, defines what ePI is (and isn’t), and takes you through its layers, processes, and technical foundations. Join us at the starting line of this transformation – and be ready to lead the change.

We are happy to greet Noemi Fernández, Regulatory Affairs Specialist at Laboratorio Reig Jofre, in this session. She accompanies you through their journey to IDMP readiness with EXTEDO - from first hurdles to the results - and offers practical insights into the real-world impact of a RIM system.

Let's meet in London to drive Excellence in Drug Safety & Pharmacovigilance together.