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A regulatory sandbox establishes a time-limited framework in which developers can design, validate, and test innovative medicines or methodologies in a controlled, real-world environment, under strict regulatory oversight.
The reform of the EU pharmaceutical legislation includes regulatory sandboxes as a tool to test, under the direct supervision of the competent authorities, adapted requirements for innovative medicines that cannot be developed under current rules.
The aim of this workshop is to discuss aspects of the implementation of EU regulatory sandboxes as laid out in the revised pharmaceutical legislation, how sandboxes work, and what is necessary to implement and execute them effectively.
Registration by invitation only.
Video recording is published after the event.