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Legal & Regulatory Affairs Committee

The Legal & Regulatory Affairs Committee was established in 2017 to guide the EBMT’s interactions with national and European regulatory authorities and other bodies.

The Committee anticipates a demanding workload and is happy to receive expressions of interest in joining from other EBMT colleagues with an interest in regulatory matters.
 
The LRAC is supported by Eoin McGrath, the JACIE Operations Manager. Please use the "Contact us" button below to communicate with us in relation to the committee's activities. Alternatively, telephone +34 93 453 8570.

LRAC Team

Committee Objectives

The LRAC will build on existing relationships and play a watchdog role in terms of reporting on changes in regulations and guidelines that affect our sector.

Activities

  • Contact EBMT members who are already acting in an expert capacity with the EU in order to bring their knowledge and experience into the LRAC.
  • Prepare the EBMT’s contribution to the EU’s evaluation of the Tissue and Cells Directives.

Recent activities with EBMT representation/participation

  • 17/05/2021 - EU Workshop Better Protection of Donors for Non-Reproductive Tissues and Cells
  • 06/05/2021 - EU Workshop Setting Technical Rules for BTC
  • 05/05/2021 - EU Workshop Regulating for Sufficiency – tissues and cells
  • 29/04/2021 - GAPP Joint Action Work Package 6 Technical Meeting
  • 22/04/2021 - RWE4Decisions meeting Co-Creating RWE Excellence for Decision-Making: Meeting Regulatory and HTA/Payer Needs
  • 16/04/2021 - DG SANTÉ NCAPR ‘pro-action’ coffee on CAR-T pricing and evidence
  • 15/04/2021 - Submitted EBMT response to the EU Targetted Consultation on the Blood, Tissues and Cells Framework
  • 08/02/2021 - MHRA (UK) Stakeholder Engagement Meeting on ATMP Centre Accreditation

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