Talk Regulatory Strategy & EU Pharmaceutical Policy track
S0905 - Regulatory Sandbox: Enabling factors on the road toward a successful implementation
Wed, Mar 19, 2025 · 3:00–4:10 PM CET Singapore Room, Congress Center Basel
About this session
A regulatory sandbox is a regulatory experimentation mechanism, which aims at learning about opportunities and risks that a particular innovation carries and to developing the right regulatory environment to accommodate when the latter do not fit with existing framework. The recent positive nod in the EU GPL endorsing the regulatory sandboxes as an important future-proofing element for innovation, signals a positive momentum to invite experimentation and adopt healthcare transformative solutions.
Building on the previous dedicated session at EU DIA 2023 and 2024, this session aims to further explore how Europe can best take advantage of the concept. The upcoming IHI regulatory sandbox project running from 2025 to 2028 to progress and successfully implement regulatory sandboxes offers a timely opportunity to discuss the necessary principles for the sandbox's effectiveness, sustainability, optimal integration within the broader regulatory toolbox and ability to make a difference in Europe.
Programme:
- 2. Sandboxes - The New Regulatory Tool Enabling Real-Life Testing of Innovative Concepts — Falk Ehmann
- 3. Regulatory Sandbox - Upcoming IHI Project — Magdalini Papadaki
- 1. Introduction — Francois Hebraud
- Panel Discussion — Francois Hebraud, Falk Ehmann, Magdalini Papadaki
