Hard Reg Café are sessions organised by the CATALONIA.HEALTH Regulatory Affairs Workgroup to address companies’ concerns and training needs associated with the regulatory framework for healthcare products (biopharmaceuticals, diagnostics, medical devices and digital health).

The sessions are held roughly once a quarter and feature international experts in this strategic field.

Between 2018 and 2020, nine sessions were held with 17 speakers and more than 200 professionals.

For members and non-members

Previous editions

• Hard Reg Café: "The ISO IDMP regulatory framework in relation to the SPOR programme" 
• Hard Reg Café "A multi-faceted view of the ATMPs regulatory challenges"
• 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 Cafè "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 the Regulatory Affairs Workgroup 

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