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 Chairs:


 

Christopher Bravery, PhD
Co-Chair
June 2019 - June 2021 
Consulting on Advanced Biologicals LtdLondon, United Kingdom 

Karin Hoogendoorn, PharmD
Co-Chair
June 2019 - June 2021
Quality RA
Utrecht, Netherlands 

 

Committee Members:

Mohamed Abou-El- Enein, MD, PhD
Charité - Universitätsmedizin Berlin
Berlin, Germany

Natividad Cuende, MD, MPH, PhD
Andalusian Initiative for Advanced Therapies
Sevilla, Spain
Massimo Dominici, MD
University Hospital of Modena
Modena, Italy 
Miguel Forte, MD, PhD
Zelluna Immunotherapy
Oslo, Norway
Paula Salmikangas, PhD
NDA Advisory Services
Klaukkala, Finland
Mariele Vigano, PhD
Fondazione IRCCS Ca' Granda Ospedale
Milan, Italy
Maarten Zandvliet, PharmD, PhD
CellPoint B.V
Leiden, Netherlands

 

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