The CataloniaBio & HealthTech Regulatory Affairs Workgroup invites you to participate in its third Hard Reg Café meeting on June 5 in Barcelona to share the key steps biomedical companies and start-ups have to follow in order to gain Food and Drug Administration (FDA) approval for new drugs. With the support of ACCIÓ (Government of Catalonia).

Keynote Speakers

Bruce Thompson, Principal of Reguliance (US)
Scott Freeman, Regulatory Affairs Specialist at Reguliance (US)

Agenda

9:15 am  Registration and welcoming coffee

9:30 am  Welcome and introduction of speakers

CataloniaBioHT board members Lidia Cánovas, general manager of Asphalion, and Lluís Chico, managing partner of NEOS Surgery

9:45 am  FDA regulatory affairs during drug development

• Overview of key regulatory topics during product development phases
• Agent requirements and formal meetings with FDA

10:30 am  Orphan Drug Designation (ODD)

• US ODD requirements 
• Comparison EU vs USA 

11:15 am  Coffee Break

11:45 am  Expedited pathways 

• Comprehensive overview of alternative pathways that speed up registration 
• Breakthrough therapy, fast track, accelerated approval, and priority review overview of FDA incentives: Vouchers, Waivers and Designations 

12:45 pm  Question-and-answer session

Capacity: limited spots

Language: English

Registration fees:

• CataloniaBioHT members: free
• Non-members: €50 (VAT included). You will be invoiced €50/person

What is Hard Reg Café?

It is a series of coffee work meetings, held once a quarter, to share concerns regarding regulatory issues, debate topics of interest or bring a prestigious guest in this strategic field for CataloniaBio & HealthTech biopharmaceutical, medical technology and digital health start-ups and companies.

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