Upcoming Events

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.

Discover the key differences in EMA and US FDA eCTD v4 requirements and learn what they mean for your regulatory submissions. Join this session for a concise look at the practical nuances between EMA and US FDA eCTD v4 - and how they impact your submission strategy!

The upcoming revision of EU GMP Annex 11 will bring changes that could significantly impact regulated IT systems in Life Sciences. Join this complimentary webinar for a focused session comparing the current effective version with the revised draft, exploring selected topics in depth, and sharing practical recommendations to help you prepare.

Identify the key players driving the ePI ecosystem and learn how their roles and collaboration shape its future. shaping the ePI landscape and learn how their collaboration drives progress – with insights straight from seasoned experts.

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

Understand the unique impact ePI has on different stakeholders and gain fresh perspectives on its value and implications.

Discover how ePI influences organisations, streamlines processes, enhances systems, and builds essential skills for the future.

Learn the practical steps and strategies to prepare for ePI, ensuring your organisation is ready to adapt and thrive

Explore how to design a robust ePI strategy that ensures a smooth, future‑proof implementation.

Celebrate your progress and join a thriving ePI community that fosters ongoing learning, collaboration, and growth.