CATALONIA.HEALTH, in collaboration with Ingecal and AENOR, organises the next Hard Reg Café on innovation management certification in a face-to-face workshop format.

ISO 56001:2024 (formerly UNE 166002) is an international standard that sets out the requirements for the implementation and improvement of an innovation management system within an organization. It provides a structured framework to foster an innovative culture, manage ideas and transform them into real value while integrating processes that ensure the sustainability and effectiveness of innovation. This certification helps organizations to be more competitive by systematizing innovation and aligning it with their strategic objectives.

The session, promoted by the Internal Innovation Committee of CATALONIA.HEALTH, is designed to inform both experts in this certification, and those interested in exploring whether it could be a valuable opportunity for their company or organization.

Speakers:

• Evaristo Gutiérrez is the CEO and founder of INGECAL, an industrial technical engineer, and holds a master’s in operations management from ESADE. With extensive experience as a consultant, trainer, and auditor in innovation management systems, he has led INGECAL since 2000, offering consulting, training, and internal auditing services to companies and organizations across various sectors.
• Malvido Gerardo, after years dedicated to Research and Development in the Automotive and Health sectors across several European countries, has been contributing since 2002 as an expert in drafting technical standards, designing audit schemes, and certification processes within AENOR's R&D&I unit.

Program

8:45 - 9:00 | Registration

9:00 - 9:50 | Informative session

• Welcome by Anna Riera, Head of Innovation at the Josep Carreras Leukaemia Research Institute (IJC) and member of the Internal Innovation Committee of CATALONIA.HEALTH. 
• Explanation of the ISO regulation by Ingecal, and its certification by AENOR.
• Q&A session.

9:50 - 10:30 | Workshop: Defining an Innovation Culture in an organization 

• There will be a group exercise, and a sharing of the conclusions obtained from the exercise.

10:30 - 11:00 | Coffee & Networking

For: The entire healthcare sector, including hospitals, managers, biotech, and tech companies, with a practical approach to understanding and applying innovation best practices.

Language: Catalan/Spanish

Registration: 

• CATALONIA.HEALTH member: free
• CATALONIA.HEALTH non-members: €50 (VAT not included)

Questions: Roser Alba (Project Manager) · roser.alba@catalonia.health

What is Hard Reg Café?

It is a series of coffee work meetings to share concerns regarding regulatory issues, debate topics of interest or bring a prestigious guest in this strategic field for CATALONIA.HEALTH startups and companies.

Previous meetings:

• 1st Hard Reg Café "Briefing Meeting" 
• 2nd Hard Reg Café "Briefing Meeting"
• 3rd Hard Reg Café "FDA, ODD and Expedited pathways"
• 4th Hard Reg Café: "The new EU MDR"
• 5th Hard Reg Café:  "Understanding EUDAMED" 
• 6th Hard Reg Café: "Experiències i procediments d'excepció per a producte sanitari i EPIs en la crisi de la Covid-19"
• 7th Hard Reg Café "Open talk with EU Notified Bodies about the extra transition year to implement MDR"
• 8th Hard Reg Café "Regulatory and clinical evaluations in digital health solutions"
• 9th Hard Reg Café: "Regulatory and clinical evaluations in digital health solutions"
• 10th Hard Reg Café: "The ISO IDMP regulatory framework in relation to the SPOR programme"

With the support of