European training for tissue bank personnel

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 personnels 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