Are you part of a research project under the Innovative Medicines Initiative (IMI) or the Innovative Health Initiative (IHI)? Do you want to understand what regulatory impact is and how to achieve it? Then join us on 10 December at 14:00 for this online event and seize the opportunity to hear from the EMA experts about the best ways for IHI projects to engage with regulators.
Why attend?
Regulatory endorsement can significantly enhance the credibility and applicability of your research results. During this event, you will hear from the EMA and from previous IMI projects and you will:
- Hear about what regulatory science and innovation is
- Understand why regulatory endorsement matters for project outputs
- Learn about the importance of defining a regulatory strategy from the outset
- Find out about the support services offered by the European Medicines Agency (EMA) for applicants and consortia
- Gain insights from lessons learned by other previous IMI projects that have successfully navigated regulatory processes
- See how maximising regulatory impact can benefit your project and consortium, and beyond.
Remember! This is an interactive event with opportunity to directly ask your questions to the experts. You can even send them ahead of time, via the registration form.
Who should attend?
This event is open to everyone, but it is particularly relevant for academic researchers, SMEs, patients organisation, healthcare providers and private companies involved in IMI/IHI projects and more broadly in public-private collaborative research projects:
Whether you are new to regulatory processes or looking to refine your approach, this event will provide valuable guidance and practical tips.
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
Scientific Advice, Scientific Evidence Generation Department, Human Medicines Division
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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Head of Workstream Real-world Evidence, Task Force Data Analytics and Methods
European Medicines Agency
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Workstream Regulatory Science and Academia, Task Force Regulatory Science and Innovation
European Medicines Agency
Head of the Task Force on Data Analytics and Methods
European Medicines Agency
Senior Scientific Project Manager
Innovative Health Initiative
Reading material