Build regulatory competence for FDA submissions.
In this module participants will learn to navigate through foreign regulatory frameworks. The module provides an overview of the global regulatory landscape and current developments, including practical applications and best practices. The module in particular covers an introduction to the US FDA regulatory infrastructure and framework, with a focus on the expectations in pre-market submissions, including the different types of medical device submission pathways.
On-site (in-person) events:
- 29.04.2026 (9-3pm) - Kickoff
- 12.06.2026 (9-5pm) - Wrap up and presentation
These dates might be subject to change
In between those two onsite events you will have access to our online learning-platform with extensive individual learning opportunities.
