Legal and Regulatory Affairs Committee: Europe

 Charter

 

The European Legal and Regulatory Affairs Committee (EU LRA) of the ISCT serves the membership and others working in cellular therapy by providing information regarding European regulations, standards and guidance documents, and presenting the regulatory concerns of the membership back to the regulatory agencies.  


Projects and Objectives

  • ISCT Annual Meeting: The EU LRA is actively involved in the organization of the ISCT Annual Meeting. The EU LRA topic interests are included in the the Quality and Operations Track. This committee also participates in the review of abstract submissions.
  • ISCT Global Regulatory Perspectives (GRP) Workshop: The EU LRA is actively involved in the development of the annual GRP Pre-Conference Workshop that runs in conjunction with the annual meeting.
  • Educational Webinars: The EU LRA is involved in the planning of online webinar seminars.
  • EU LRA Watchdog: The committee develops frequent watchdog notifications of relevant EMA/EU Commission and related regulatory news updates to the membership. These watchdog announcements are featured in the Telegraft.

Publications:

The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholder's concerns (Cytotherapy 2014, 16: 1597-1600)


 


Committee Members:


 

Natividad Cuende, MD, MPH, PhD
Chair
Andalusian Initiative for Advanced Therapies
Sevilla, Spain

Mohamed Abou-El- Enein
Charité - Universit√§tsmedizin Berlin
Berlin, Germany

Tina Amini, PharmD, PhD
BSI Group
London, United Kingdom
Christelle Boniface
TxCell
Valbonne, France
Christopher Bravery, PhD
Consulting on Advanced Biologicals Ltd
London, United Kingdom
Massimo Dominici, MD
University Hospital of Modena
Modena, Italy 
Miguel Forte, MD, PhD
TxCell SA
Valbonne, France
Rosaria Giordano, MD
Fondazione Ospedale Maggiore Policlinico
Milan, Italy 
Rosa M. Gonzalo, PhD
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain 
Karin Hoogendoorn, PharmD
Quality RA
Leiden, Netherlands 
Gerno Schmiedeknecht, PhD
Fraunhofer IZI
Leipzig, Germany
Jean-Hugues Trouvin, PharmD
University Paris Descartes and Assistance
Publique Hopitaux de Paris
Paris, France
Ulrike Verzetnitsch, MSc
Apceth GmbH & Co. KG
Munich, Germany

Edwin Wagena, PhD
Rexgenero
United Kingdom 
Maarten Zandvliet, PharmD, PhD
Leiden University Medical center
Leiden, Netherlands

 

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