In this training session, Carmen Martín, CEO and Founder of CMGMedDev, explores the key regulatory aspects for paediatric medical devices – from how to define your product’s intended purpose to how this affects classification and regulatory strategy.
Key topics:
✅ Defining the product’s intended purpose
✅ Impact on classification and regulatory strategy
✅ Expected processes, timelines, and investment
✅ Specific paediatric regulations: Orphan Medical Devices, PIPs, and more
Aimed at innovators, entrepreneurs, and regulatory professionals working in paediatric and maternal healthcare.
Session in Spanish.
Training session with Dr. Gearóid McGauran, Medical Officer at the Health Products Regulatory Authority (HPRA), Ireland, lead author of MDCG 2024-10—the essential EU guidance on orphan medical devices—and a key member of the MDCG Orphan Device Taskforce and CIE Working Group.
INSIGHTS:
- Understand EU regulatory pathways for orphan medical devices
- Learn directly from one of Europe’s leading regulatory experts
- Ask your questions and get expert insights in real-time
Discover more about the projects, activities, and proposals of i4KIDS and i4KIDS-EUROPE, as well as the current state of innovation in paediatric and maternal health in Europe.
Additionally, we will explore the strategic actions presented in our White Paper, aimed at overcoming the barriers affecting the development of innovation in Europe.
🎤 Speakers:
✅ Arnau Valls Esteve – Sant Joan de Déu Barcelona Children’s Hospital
✅ Charlotte Bertaud – EIT Health Spain
✅ Guillem Figueras Manzanares – Inveniam Group
✅ Ilona Platonova – Bērnu klīniskā universitātes slimnīca
i4KIDS Training Capsule that dives into funding options and investment strategies for paediatric projects, highlighting successful models (private and public) and uncovering exciting opportunities.
Panel of Experts:
- David Cole, MBA – Director and CCHO, TOO Futures Ltd (UK)
- John Parker – Founder and Managing Partner, Springhood Ventures (US)
- Kerstin Papenfuss, PhD MBA – Director Pharma at Deep Science Ventures (UK)
- Marc Ramis Castelltort – Managing Partner, Montana Impact Fund (Spain)
The discussion leverages insights from the i4KIDSEUROPE report: “Europe Paediatric Innovation Situation Report and Needs Analysis” to offer guidance for founders and start-ups navigating the paediatric funding landscape.
i4KIDS Training Capsule that analyses the adoption process that took place at Sant Joan de Déu Barcelona Children’s Hospital and its diabetes unit. Speakers:
- Luisa Martinez Colom: Head of Research at the Directorate of Research, Innovation and Learning, specialist in innovative public procurement and Value Health Care.
- Roque Cardona-Hernandez: Paediatric endocrinologist, clinical researcher, and head of the Diabetes Unit. Roque leads the largest paediatric diabetes centre in Spain and focuses on new therapies and technologies for type 1 diabetes.
In this training session, Carmen Martín, CEO and Founder of CMGMedDev, explores the key regulatory aspects for paediatric medical devices – from how to define your product’s intended purpose to how this affects classification and regulatory strategy.
Key topics:
✅ Defining the product’s intended purpose
✅ Impact on classification and regulatory strategy
✅ Expected processes, timelines, and investment
✅ Specific paediatric regulations: Orphan Medical Devices, PIPs, and more
Aimed at innovators, entrepreneurs, and regulatory professionals working in paediatric and maternal healthcare.
Session in Spanish.
Training session focused on learning about three groundbreaking projects—DeCODe, ORPHADEV4KIDS, and i4KIDS-4RARE—who are working together to build a supportive ecosystem for rare diseases paediatric medical innovation across Europe, supported by the EU4Health Programme.
- Sandra Brasil, Scientific and Communications Manager at EPTRI, coordinator of the ORPHADEV4KIDS Project
- Anneliene Jonker, Assistant Professor, University of Twente and Coordinator of the DeCODe Project
- Sofía Ferreira, Innovation Manager, SJD Barcelona Children’s Hospital and Coordinator of the i4KIDS-4RARE Project
Training session focused on learning about three groundbreaking projects—DeCODe, ORPHADEV4KIDS, and i4KIDS-4RARE—who are working together to build a supportive ecosystem for rare diseases paediatric medical innovation across Europe, supported by the EU4Health Programme.
- Sandra Brasil, Scientific and Communications Manager at EPTRI, coordinator of the ORPHADEV4KIDS Project
- Anneliene Jonker, Assistant Professor, University of Twente and Coordinator of the DeCODe Project
- Sofía Ferreira, Innovation Manager, SJD Barcelona Children’s Hospital and Coordinator of the i4KIDS-4RARE Project
Training session with Silvia Pérez García, Head of Life Sciences at Inveniam Group focused on “Willingness to Pay in Paediatrics: a strategic tool for early health economic analysis”.
INSIGHTS:
- The concept of Willingness to Pay (WTP) in paediatric healthcare
- How WTP supports early health economic evaluation
- Methods to measure WTP: surveys, preference studies, DCEs
- A practical case: building a WTP survey for a new paediatric therapy
Training session with Dr. Gearóid McGauran, Medical Officer at the Health Products Regulatory Authority (HPRA), Ireland, lead author of MDCG 2024-10—the essential EU guidance on orphan medical devices—and a key member of the MDCG Orphan Device Taskforce and CIE Working Group.
INSIGHTS:
- Understand EU regulatory pathways for orphan medical devices
- Learn directly from one of Europe’s leading regulatory experts
- Ask your questions and get expert insights in real-time
Discover more about the projects, activities, and proposals of i4KIDS and i4KIDS-EUROPE, as well as the current state of innovation in paediatric and maternal health in Europe.
Additionally, we will explore the strategic actions presented in our White Paper, aimed at overcoming the barriers affecting the development of innovation in Europe.
🎤 Speakers:
✅ Arnau Valls Esteve – Sant Joan de Déu Barcelona Children’s Hospital
✅ Charlotte Bertaud – EIT Health Spain
✅ Guillem Figueras Manzanares – Inveniam Group
✅ Ilona Platonova – Bērnu klīniskā universitātes slimnīca
i4KIDS Training Capsule that dives into funding options and investment strategies for paediatric projects, highlighting successful models (private and public) and uncovering exciting opportunities.
Panel of Experts:
- David Cole, MBA – Director and CCHO, TOO Futures Ltd (UK)
- John Parker – Founder and Managing Partner, Springhood Ventures (US)
- Kerstin Papenfuss, PhD MBA – Director Pharma at Deep Science Ventures (UK)
- Marc Ramis Castelltort – Managing Partner, Montana Impact Fund (Spain)
The discussion leverages insights from the i4KIDSEUROPE report: “Europe Paediatric Innovation Situation Report and Needs Analysis” to offer guidance for founders and start-ups navigating the paediatric funding landscape.
i4KIDS Training Capsule that analyses the adoption process that took place at Sant Joan de Déu Barcelona Children’s Hospital and its diabetes unit. Speakers:
- Luisa Martinez Colom: Head of Research at the Directorate of Research, Innovation and Learning, specialist in innovative public procurement and Value Health Care.
- Roque Cardona-Hernandez: Paediatric endocrinologist, clinical researcher, and head of the Diabetes Unit. Roque leads the largest paediatric diabetes centre in Spain and focuses on new therapies and technologies for type 1 diabetes.
In this training session, Carmen Martín, CEO and Founder of CMGMedDev, explores the key regulatory aspects for paediatric medical devices – from how to define your product’s intended purpose to how this affects classification and regulatory strategy.
Key topics:
✅ Defining the product’s intended purpose
✅ Impact on classification and regulatory strategy
✅ Expected processes, timelines, and investment
✅ Specific paediatric regulations: Orphan Medical Devices, PIPs, and more
Aimed at innovators, entrepreneurs, and regulatory professionals working in paediatric and maternal healthcare.
Session in Spanish.
Training session focused on learning about three groundbreaking projects—DeCODe, ORPHADEV4KIDS, and i4KIDS-4RARE—who are working together to build a supportive ecosystem for rare diseases paediatric medical innovation across Europe, supported by the EU4Health Programme.
- Sandra Brasil, Scientific and Communications Manager at EPTRI, coordinator of the ORPHADEV4KIDS Project
- Anneliene Jonker, Assistant Professor, University of Twente and Coordinator of the DeCODe Project
- Sofía Ferreira, Innovation Manager, SJD Barcelona Children’s Hospital and Coordinator of the i4KIDS-4RARE Project
Training session focused on learning about three groundbreaking projects—DeCODe, ORPHADEV4KIDS, and i4KIDS-4RARE—who are working together to build a supportive ecosystem for rare diseases paediatric medical innovation across Europe, supported by the EU4Health Programme.
- Sandra Brasil, Scientific and Communications Manager at EPTRI, coordinator of the ORPHADEV4KIDS Project
- Anneliene Jonker, Assistant Professor, University of Twente and Coordinator of the DeCODe Project
- Sofía Ferreira, Innovation Manager, SJD Barcelona Children’s Hospital and Coordinator of the i4KIDS-4RARE Project
Training session with Silvia Pérez García, Head of Life Sciences at Inveniam Group focused on “Willingness to Pay in Paediatrics: a strategic tool for early health economic analysis”.
INSIGHTS:
- The concept of Willingness to Pay (WTP) in paediatric healthcare
- How WTP supports early health economic evaluation
- Methods to measure WTP: surveys, preference studies, DCEs
- A practical case: building a WTP survey for a new paediatric therapy