CataloniaBio & HealthTech carries out its activities through the Board of Directors, executive team and Workgroups made up of executives, entrepreneurs and specialists from member companies and knowledge stakeholders. 

This way, we create spaces for active participation and debate, where participants share experiences and knowledge to promote key aspects for making companies more competitive, such as regulatory affairs.

Goals

The goals of the Regulatory Affairs Workgroup are to:

• Help CataloniaBio&HealthTech companies stay up to date on the latest regulatory changes.
• Foster institutional relationships with regulatory agencies.
• Help transfer experiences and know-how.
• Give participants the opportunity to express their concerns, propose activities and participate in executing them.

Coordinators

• Lluís Chico, first vice-president of CataloniaBio & HealthTech and managing partner of NEOS Surgery
• Lídia Cánovas, CataloniaBio & HealthTech boar member and general manager for Regulatory Affairs of Asphalion
• Melqui Calzado, general secretary of CataloniaBio & HealthTech

Previous activities

• Hard Reg Café "Regulatory and clinical evaluations in digital health solutions"
• Hard Reg Café "Open talk with EU Notified Bodies about the extra transition year to implement MDR"
• Hard Reg Café "Procediments d'excepció per a producte sanitari i EPIs en la crisi de la Covid-19"
• Hard Reg Café "Understanding EUDAMED"
• Hard Reg Café "The new EU MDR"
• Hard Reg Café "FDA, ODD and Expedited pathways"
• Hard Reg Café "Briefing Meeting" (II)
• Hard Reg Café "Briefing Meeting" (I)
• Presentation of Regulatory Affairs Workgroup