ROUNDTABLE How will the EU SoHo Regulation Impact your Cell Collection?
Wednesday, May 31, 2023 01:00 PM - 02:00 PM
Room 243
Regulation & Reimbursement
Roundtable
What are the implications for cell collection based on the European Commission's proposal to combine directives for blood, tissue, and cells?
Moderator
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd., UK
Alejandro Barquero, MSc, DanausGT Biotechnology Ltd, Spain
Panelists
Stefaan Van der Spiegel, MD, Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE), European Commission, Belgium
Marta López Fraga, PhD, European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe, France
Ingrid Seidel, Senior Director GMP Services, Cellex Cell Professionals, Germany
Session Description
The European Commission is currently revising the existing Directives for blood and tissues and cells. The new draft Regulation proposes to combine both as Substances of Human Origin (SoHo). This roundtable will discuss the potential impact on this for those who collect cells for therapeutic uses, including cell/tissue transplantation and ATMP.
Learning Objectives
Moderator
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd., UK
Alejandro Barquero, MSc, DanausGT Biotechnology Ltd, Spain
Panelists
Stefaan Van der Spiegel, MD, Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE), European Commission, Belgium
Marta López Fraga, PhD, European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe, France
Ingrid Seidel, Senior Director GMP Services, Cellex Cell Professionals, Germany
Session Description
The European Commission is currently revising the existing Directives for blood and tissues and cells. The new draft Regulation proposes to combine both as Substances of Human Origin (SoHo). This roundtable will discuss the potential impact on this for those who collect cells for therapeutic uses, including cell/tissue transplantation and ATMP.
Learning Objectives
- To understand how the new SoHo regulation will impact the collection of human cells and tissues for transplantation or manufacturing of ATMP
- To understand the future role of EDQM in setting standards
Marta Lopez-Fraga PhD
Scientific Officer
European Directorate for the Quality of Medicines and HealthCare (EDQM)
Panelist
Scientific Officer
European Directorate for the Quality of Medicines and HealthCare (EDQM)
Panelist
Ingrid Maria Seidel
Senior Director GMP Services
GMP Cellex Manufacturing Transport and Logistics GmbH
Panelist
Senior Director GMP Services
GMP Cellex Manufacturing Transport and Logistics GmbH
Panelist
Stefaan Van der Spiegel MD
Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)
European Commission
Panelist
Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)
European Commission
Panelist