The CataloniaBio & HealthTech Regulatory Affairs Workgroup is holding its 9th Hard Reg Café entitled A multi-faceted view of the ATMPs' regulatory challenges on 28 April, online, with the support of ACCIÓ (Government of Catalonia).

Advanced Therapy Medicinal Products (ATMPs) are highly innovative drugs based on the use of genes (gene therapy), tissues (tissue engineering) and cells (cell therapy). They offer ground-breaking new opportunities for personalised treatment, but the regulatory pathways for their developments are not simple.

In this open discussion session, the speakers will share experiences about the classification of ATMPs (including combined ATMPs), global regulatory requirements, and the often-challenging regulatory problems that ATMPs face from multiple points of view, including regulator, clinician, product-development company and advisor.

Welcome by Lluís Chico, managing partner of NEOS Surgery and first vice-president of CataloniaBio & HealthTech.

Speakers:

• Christopher Mann, Scientific & Regulatory Affairs Director at Asphalion
• Jürgen Bednarz, head of Regulatory Affairs of TETEC (a BBraun Group company)
• Manel Juan, head of Immunology at the Biomedical Diagnostic Centre of Hospital Clinic Barcelona and head of the Immunotherapy Platform at SJD Barcelona Children’s Hospital-Hospital Clinic

• Sol Ruiz, Head of Biologics, Biotechnology and Advanced Therapies at the Spanish Agency of Medicines and Medical Devices (AEMPS)

Closing remarks by Lidia Cánovas, general manager for Regulatory Affairs at Asphalion and CataloniaBio & HealthTech board member.

PROGRAMME

Follow us on Twitter with the hashtag #RegulatoryATMP

For: product development managers, regulatory managers and consultants to startups and companies focusing on biotechnology, pharmaceuticals and medical technology. 

Language: English

Registration fees: 

• CataloniaBio & HealthTech members: free 
• Non-members: €50 (VAT not included). You will be invoiced €50/person.

This session will be in a Zoom webinar. Access will be activated 5 minutes before the session (the link will be sent to the participants registered).

Questions: secretaria@cataloniabioht.org

Related information:

Report: "Advanced therapies: the complicated regulatory pathway"

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 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"