Upcoming Events

China’s upcoming eCTD v1.1 update is set to reshape submission processes. Join our experts as they break down what’s changing, what it means for your organization, and how to prepare now to stay ahead. This live webinar will give you clarity on timelines and requiements, plus a sneak peek into our Submission Management Hub in action.

Regulatory deadlines are fixed, but eCTD v4 introduces new complexity and workload for submission teams. Join our Publishing Services experts to learn how dedicated eCTD v4 publishing support ensures compliant, on-time eCTD v4 submissions, e.g. to EMA or the US FDA.

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.

Together, we experience Sustainability, Innovation, and Collaboration - join us in Rotterdam!

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.

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