About the i4Kids-Europe Pediatric Innovation Training  Capsules

i4Kids-Europe is a european project that aims at establishing an efficient, perdurable and inclusive European pediatric innovation ecosystem that integrates all pertinent stakeholders from emerging, moderate and strong innovator countries, offering the necessary services and resources to improve the pediatric innovation capacity of the EU countries. 
To tackle the identified gaps and barriers within the european pediatric ecosystem, we will provide 12 modules to decrease access barriers and reach a wide and diverse stakeholders.
Each module will focus on a specific identified challenge to provide the tools needed to take advantage of innovation opportunities in the pediatric field, including first-hand experiences from key actors of the European ecosystem.

Next training: 17th April 2024, 13:00-14:00

Capsule 4: MDR and drugs for pediatrics: how to navigate within the regulatory ocean? 

Regulatory has been identified as the second most important barrier in Europe in the situation report and needs analysis that we've published as i4KIDS-EUROPE. Indeed, 60% of respondents "agree" or "strongly agree" that regulatory & reimbursement barriers pose an impediment to their innovation in paediatrics. Additionnaly, 78%  indicated that staying financially viable during the clinical development phase is a key struggle, both for research institutions and start-ups.


Regulation is perceived as a significant burden and the regulatory pathways in pediatrics can be more challenging: the pediatric population is diverse, spanning newborns to adolescents, necessitating the adaptation of clinical research based on age groups. 

Xavier Luria, an expert in Medical Devices and Drugs regulation, with extended experience at EMA, will shed light on how to navigate the regulatory scheme and landscape existing in Europe. 
He will help us drive innovation through the regulatory roadmaps for both Medical Devices Regulation (MDR) and Drugs Regulation.

 

Following this master class, we will open up a 15-minute Q&A session, providing the audience with the opportunity to exhange ideas. We look forward to an interactive and insightful discussion.

First-hand experiences of innovative pediatric start-ups

Women innovators and female leadership in pediatrics

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