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 & 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)
  
  

The Committee

Chair

Christopher Bravery, PhD
Consulting on Advanced Biologicals Ltd.
London, United Kingdom

Members

Alejandro Barquero, MPharm, MSc
Almirall
Barcelona, Spain

Björn Carlsson, PhD
NDA Group
Sweden

Rosaria Giordano, MD
Fondazione Ospedale Maggiore Policlinico
Milan, Italy

Geeta Jotwani, PhD
Indian Council of Medical Research
New Delhi, India

Sharon Longhurst, PhD
Advanced Biologics Consulting
United Kingdom

Laura Mendieta, PhD
ESP Leadership Development Program
Asphalion
Barcelona, Spain

Christiane Niederlaender, PhD
Parexel
Germany

Bernd Schröder, PhD
Miltenyi Biotec B.V. & Co. KG
Germany

Simona Stankeviciute, MD, MSc
Parexel
Lithuania