In this session, Carmen Martín González — CEO and founder of CMG MedDev — will provide a practical and strategic overview of the regulatory pathway for innovative paediatric health solutions. Aimed at startups, researchers, and entrepreneurs, the training will explore how to approach regulatory planning from the earliest stages of development.
Key topics will include how to define the intended purpose of your product and why this single sentence can critically influence your product’s risk classification, development strategy, and approval route. Carmen will walk through the essential steps of the regulatory process, offering insights into typical timelines, required investments, and common pitfalls to avoid.
Special attention will be given to the unique regulatory challenges and opportunities in paediatrics, including updates on the regulatory framework for Orphan Medical Devices and the requirements of Paediatric Investigation Plans (PIPs) in clinical trials for paediatric medicines.
Whether you're developing a medical device, digital health solution, or a paediatric drug therapy, this session will help you understand what it takes to successfully navigate the regulatory landscape and bring your innovation to market.
IMPORTANT: Please note that this session will be conducted in Spanish.
