From Research to Clinical Application-The Quality Concept

  • P. H. Roddie
Conference paper
Part of the Developments in Hematology and Immunology book series (DIHI, volume 38)

Abstract

For those involved in clinical research in Europe there will be fundamental changes in the way clinical trials are regulated as a consequence of the European Clinical Trials Directive. EU member states have until 1 May 2003 to draw up legislation implementing the Directive, whose purpose is to ensure that quality is a mandatory component of clinical trials. Research sponsor, host institutions and investigators will be responsible for ensuring clinical trials fulfill the requirements of Good Clinical Practice (GCP) and, where studies involve the use of investigational medicinal products (IMP), Good Manufacturing Practice (GMP). The Licensing authorities will act to ensure compliance with standards, which will include performing inspection of trial and manufacturing sites. These changes offer particular challenges to those involved in translational research as the cost and resource implications are likely to be high.

Keywords

Good Clinical Practice Quality System Good Manufacture Practice Medicine Control Agency Investigational Medicinal Product 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1996) ICH Tripartite Guideline. Guideline for Good Clinical Practice. Recommended for Adoption at Step 4 of the ICH Process on 1 May 1996 by the ICH Steering Committee.Google Scholar
  2. 2.
    Medical Research Council. (1998) MRC Guidelines for Good Clinical Practice in Clinical Trials. Medical Research Council, London United KingdomGoogle Scholar
  3. 3.
    http://www.mrc.ac.uk/txt/pdf-ctg.pdf.
  4. 4.
    The Clinical Trials Directive 2001/20/EC Official Journal of the European Communities” (L121, pp34–44). http://www.europa.eu.int/eur-lex/en/search/search_lif.html
  5. 5.
    Medicines Control Agency. (2002) EU Directive on Good Clinical Practice in Clinical Trials, DH and MCA Briefing Note, MCAGoogle Scholar
  6. 6.
    EU Guide to Good Manufacturing Practice-Annex 13. (2001) Manufacture of investigational medicinal products 2001. http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/anx13en.pdf.Google Scholar
  7. 7.
    EU Guide to Good Manufacturing Practice-Annex 14. (2000) Manufacture of medicinal products derived from human blood and plasma 2000. http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/gmpanl4_en.pdf.Google Scholar
  8. 8.
    A Code of Practice for Tissue Banks, DOH, 2001. http://www.doh.gov.uk/humantissuebanking/tissuebank.pdf.
  9. 9.
    Roddie PH, Turner ML. Cellular therapy for haematological malignancies. Vox Sang 2002;83:294–304.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2003

Authors and Affiliations

  • P. H. Roddie
    • 1
  1. 1.Western General HospitalEdinburghScotland

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