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Regulating tissue and cells: our story 7 April 2006 - 25 March 2008

Regulating tissue and cells: our story 7 April 2006 - 25 March 2008. Dr Sandy Mather Director of Regulation. Aims. To share some of the highlights of the last two years in the life of HTA To explain our risk based regulatory system

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Regulating tissue and cells: our story 7 April 2006 - 25 March 2008

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  1. Regulating tissue and cells: our story 7 April 2006 - 25 March 2008 Dr Sandy Mather Director of Regulation

  2. Aims • To share some of the highlights of the last two years in the life of HTA • To explain our risk based regulatory system • To feedback lessons learned from implementing the EU Tissue and Cells Directives

  3. The highlights

  4. Programme planning approach Aug 2005 - April 2006 Phase 1a Phase 1b April 2006 – Sept 2006 Phase 2 Sept 2006 – March 2007 Phase 3 April 2007 – March 2008

  5. Phase 1a (Aug 2005 - Apr 2006)

  6. Develop the HTA’s regulatory aim - Set a clear goal To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence

  7. Workstreams Licensing Pilot methodology – any volunteers?? Standards Self assessment Designated Individual Inspections Fees EUTCD Advice and guidance Sectors to be licensed Anatomical examinations Post mortem examinations Removal of PM material Storage of PM material Storage of anatomical specimens Storage of material from a living person Public display A slide from our first workshop on the EUTCD (25 September 2005) Engage external expertise and recruit regulation team

  8. Developing a risk based regulatory system

  9. The role of the Designated Individual • How we developed our guidance • Code of Practice consultation • Telephone interviews, workshops and meetings • Letters and email • Hansard • Legal advice

  10. HTA framework - based on governance of institution Other people working on licensed premises and carrying out licensed activities do so under the direction of the Designated Individual or a Person Designated by the DI

  11. Compliance report licence application • Purpose • Allows applicant to reflect on progress against standards • Enables an evaluation of suitability for a licence

  12. Compliance report: Standards Four themes • Consent • Governance and quality systems • Premises, facilities and equipment • Disposal

  13. Two types of inspection • Phase 1 inspection: desk-based evaluation of information • All establishments • Phase 2 inspection: site visits • Scheduled according to risk

  14. Phase 1b (Apr – Sep 2006)

  15. Training programme of workshops for Designated Individuals

  16. Phase 2 (Sep 2006 – Mar 2007)

  17. Licensing and inspections programme • 400 phase 1 (desk based) inspections • Recruit regulation managers to inspect • Recruit and train interim specialist advisors • Risk based phase 2 (site visit) inspections

  18. Complete phase 1 inspections

  19. Regulating by geographical area • Scotland, East of England, North East of England and South East of England. Caroline Browne - caroline.browne@hta.gov.uk • Northern Ireland, Central England, South West England and South East England. Imogen Swann - imogen.swann@hta.gov.uk • Wales, North West England and South East England Kristi Adams - kristi.adams@hta.gov.uk

  20. Phase 3 (Apr 2007 – Mar 2008)

  21. Programme milestones – phase 3 (Apr 2007 – Mar 2008) • Advice and guidance • E-learning for Designated Individuals • HTA Conference on regulating tissues and cells • Complete 64 phase 2 inspections in human application sector

  22. Designated Individual e-learning 1. Learn it 2. Test it 3. Certification

  23. Regulating tissues and cells - the results so far

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