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Training event for Designated Individuals (DIs) in the human application sector

Training event for Designated Individuals (DIs) in the human application sector. 25 March 2009 Jodi Berg. Partnership. Role of the Human Tissue Authority under the 2004 Act To regulate the removal, storage, use and disposal of human bodies, organs and tissue for purposes set out in the Act

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Training event for Designated Individuals (DIs) in the human application sector

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  1. Training event for Designated Individuals (DIs) in the human application sector 25 March 2009 Jodi Berg

  2. Partnership • Role of the Human Tissue Authority under the 2004 Act • To regulate the removal, storage, use and disposal of human bodies, organs and tissue for purposes set out in the Act • Competent Authority under EU Tissue and Cells Directive • The Role of the DI • Key to regulation of licensing arrangements under the Act • Responsible for ensuring good practice is followed: • conditions of the licence are complied with • suitable practices are used • others who work under the licence are suitable • conditions of Third Party Agreements are complied with • recording and retention of data relating to licensable activities

  3. Purpose of this training event • Opportunity for DIs • to increase knowledge of DI role and responsibilities • to develop understanding and skills in workshops • to receive update on information relevant to the sector • to meet and discuss issues of interest with HTA staff and DIs • Opportunity for the HTA • to improve communication and understanding between the HTA and the regulated sector • to explore together how we can help to support good practice in human application establishments

  4. Agenda for today • Morning sessions – Updates on DI information and European Commission projects • Afternoon session – Workshops • Basic DI training (Executive Room 1) • Third Party Agreements (Executive Room 2) • Serious Adverse Events and Reactions (Hall) • Update on HTA licensing and arrangements and inspection process

  5. www.hta.gov.uk

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