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European training for tissue bank personnel

European training for tissue bank personnel. 25 March 2009 Emyr Harries. Aim of the session . Provide feedback from the workshop for Education and Certification of Tissue Processing Professionals. Education and Certification of Tissue Processing Professionals.

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European training for tissue bank personnel

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  1. European training for tissue bank personnel 25 March 2009 Emyr Harries

  2. Aim of the session • Provide feedback from the workshop for Education and Certification of Tissue Processing Professionals

  3. Education and Certification of Tissue Processing Professionals • Workshop held in Brussels 21-24 October 2008 • 40 delegates • Tissue banking personnel and representatives from Competent Authorities • Bone banks, eye banks, skin banks

  4. Aim of the workshop • Design and validate a specialised training model among tissue establishment personnel • Approved education recommended by the European Union members • Based on the banking personnel’s profile • Based on knowledge and training needs detected in a recently finished European coordinated EQSBT Programme • Develop method for qualifying personnel and certify their knowledge. Complete European certification system

  5. Content of workshop • Legal aspects, legal base for tissues and cells directive • DG SANCO, EU projects • ALCIMED • EUSTITE • EUROCET • Donor and tissue evaluation • Tissue procurement and conditions • Disease transmission through tissue transplantation

  6. Content of workshop • Organisational and quality aspects • Quality management system, quality control • Risk assessment and management • Quality risk management, Annex 20 of GMP guide. Failure Mode and Effects Analysis (FMEA) and Failure Mode Effects and Criticality Analysis (FMECA) • Process validation • Transport, packaging, process • Audit and inspections • Setting up an inspectorate. Inspection process • Operational conditions • Procurement, processing and clinical use. Design and plan

  7. Content of workshop • Biovigilance and surveillance • c.f. pharmacovigilance, haemovigilance • SAEARs • Practical cases • Design of the processing unit • Biovigilance analysis and tissue recall • Cases of adverse events and reactions to work on, provide rationale • Tissue banking throughout Europe • Cross-border cooperation on tissue transplantation • European cooperation on tissue transplantation • European Association of Tissue Banks (EATB) • Single European coding system

  8. Course evaluation and closing remarks • Exam performed to test level of knowledge among participants • 40 multiple choice questions • Different backgrounds of the participants. Some highly technical questions • General results were very positive and the average score was 65% • Feedback of course to EU • Future similar workshops • http://taiex.ec.europa.eu/ • Choose on the left-hand side of the screen "Library" and filter the events by number IM 30319. It will appear ‘Workshop on Tissues and Cells’ please click on "more" and you will find all available presentations

  9. www.hta.gov.uk

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