Skip to main content
SpringerLink
Log in

The Regulatory Situation for Academic Cell Therapy Facilities in Europe

  • Chapter
  • First Online:
Cell Therapy

  • 1375 Accesses

Abstract

The European Legal and Regulatory Affairs (LRA) Committee of the International Society for Cellular Therapy (ISCT) has in its mission statement (see http://www.cellulartherapy.org) to serve those working in the field of cellular and gene therapy by being a source of information regarding compliance with European Union (EU) directives, local and professional regulations and by being a voice in the moderation of external regulation. One of our main goals is to keep ISCT members up to date on potential and actual changes in regulatory affairs and to respond to the authorities in open consultations on behalf of the membership.

In this chapter we outline the current issues with regard to the European Directives (EUD) and the proposal for Advanced Cell Therapies, which are of importance to cellular therapy facilities in Europe. We recognize that not all of the legislation is finalized, so we recommend readers visit our website for more information.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Ashford P, Distler P, Gee A, Lankester A, Larsson S, Feller I, Loper K, Pamphilon D, Poston L, Rabe F, Slaper-Cortenbach I, Szczepiorkowski Z, Warkentin P. Standards for the terminology and labeling of cellular therapy products. Bone Marrow Transplantation. 2007 40(11): 1075–1083.

    Article  CAS  PubMed  Google Scholar 

  2. Ashford P, Distler P, Gee A, Lankester A, Larsson S, Feller I, Loper K, Pamphilon D, Poston L, Rabe F, Slaper-Cortenbach I, Szczepiorkowski Z, Warkentin P. ISBT 128 implementation plan for cellular therapy products. Bone Marrow Transplantation. 2007 40(11): 1085–1090.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Immunology, UMC Utrecht, The Utrecht Center for Gene and Cell Therapy, 3508, Utrecht, GA, The Netherlands

    I. Slaper-Cortenbach PhD

  2. Members of the European Legal and Regulatory Affairs (LRA) Committee of the International Society for Cellular Therapy (ISCT), V5Y 1J6, Vancouver, BC, Canada

    M. Scott PhD, FRCPath, D. Herrmann PhD, M. Introna MD, K. Theunissen MD, P. Theocharous BSc (Hon), MSc, PhD & C. Chabannon MD, PhD

Authors
  1. I. Slaper-Cortenbach PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. Scott PhD, FRCPath
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. D. Herrmann PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. M. Introna MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. K. Theunissen MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. P. Theocharous BSc (Hon), MSc, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. C. Chabannon MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to I. Slaper-Cortenbach PhD .

Editor information

Editors and Affiliations

  1. Baylor College of Medicine, Baylor Plaza 1, Houston, 77030, U.S.A.

    Adrian Gee

Rights and permissions

Reprints and permissions

Copyright information

© 2009 Springer Science+Business Media, LLC

About this chapter

Cite this chapter

Slaper-Cortenbach, I. et al. (2009). The Regulatory Situation for Academic Cell Therapy Facilities in Europe. In: Gee, A. (eds) Cell Therapy. Springer, Boston, MA. https://doi.org/10.1007/b102110_2

Download citation

Publish with us

Policies and ethics

Search

Navigation