Regulatory endorsement can significantly enhance the credibility and applicability of your research results. During this event, you heard from the EMA and from previous IMI projects and you:
- Heard about what regulatory science and innovation is
- Understood why regulatory endorsement matters for project outputs
- Learned about the importance of defining a regulatory strategy from the outset
- Found out about the support services offered by the European Medicines Agency (EMA) for applicants and consortia
- Gained insights from lessons learned by other previous IMI projects that have successfully navigated regulatory processes
- Saw how maximising regulatory impact can benefit your project and consortium, and beyond.
Session recording and Presentation
Agenda
- Welcome and opening remarks
- Introduction to regulatory science and innovation: how consortia can advance regulatory science and enable medical innovations
- How to engage with EMA: tips, advice and opportunities
- In the footsteps of our projects: learning from past successes
- From engaging with regulators to regulatory impact: benefits for the consortia and for health care and research systems
- Questions from the audience
- Closing remarks
Meet the speakers
Head of Workstream Regulatory Science and Academia,
Task Force Regulatory Science and Innovation
European Medicines Agency
Senior Scientific Officer
Innovative Health Initiative
Scientific Advice, Scientific Evidence Generation Department, Human Medicines Division
European Medicines Agency
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Workstream Innovation & Development Accelerator,
Task Force Regulatory Science and Innovation
European Medicines Agency
Head of Expert Panels and Groups, Committees and Quality Assurance Department, Human Medicines Division
European Medicines Agency
Workstream Regulatory Science and Academia, Task Force Regulatory Science and Innovation
European Medicines Agency
Project lead for the AMYPAD project
GE Healthcare
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Leader of the regulatory work package in the
MOBILISE-D project
University of Bologna
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Academic co-lead of the regulatory work package in the MOBILISE-D project
University of Bologna
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Academic leader for the work package on determination of drug transfer and infant drug exposure during lactation for the ConcePTION project
KU Leuven and BioNotus
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Workstream Regulatory Science and Academia, Task Force Regulatory Science and Innovation
European Medicines Agency
Reading material