Roundtable Regulatory Strategy & EU Pharmaceutical Policy track
S0904 - The Impact of Changes to the EU Regulatory Framework on its Ability to Oversee Future Innovation
Thu, Mar 20, 2025 · 10:30–11:40 AM CET Delhi Room, Congress Center Basel
About this session
The EU regulatory framework has been successful in ensuring that high quality, safe and efficacious medicines get to patients. However, the framework has become complex, inefficient and difficult to navigate. The revision of the general pharmaceutical legislation is an opportunity to address the shortcomings of the current framework, reinstate the EU system as world-leading, and ensure it keeps abreast of technological progress.
In this highly interactive session, participants will be able to join multistakeholder roundtable discussions reflecting on the impact of the changes to the EU Regulatory framework and how it allows and stimulates future innovation, with a focus on expedited pathways, compassionate use, scientific advice and qualification.
Programme:
- 1. GPL Innovation: A Focus on the General Regulatory Framework — Sini Eskola, Nick Sykes
- 0. Setting the Scene — Rebecca Lumsden, Tamara Di Carlantonio
- 2. GPL Innovation: A Focus on Expedited Pathways — Nad�ge Le Roux
- 3. GPL Innovation: A Focus on Compassionate Use — Nina Heiss
- 4. GPL Innovation: A Focus on Scientific Advice — Laura Oliveira, Alexa Hunter
- 5. GPL Innovation: A Focus on Qualification — Cathelijne de Gram
Speakers
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Head of International Regulatory Policy and Innovation, Executive Director · Takeda
Chair
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Senior Director Science and Regulatory Policy · MSD
Speaker
