50 likes | 132 Views
Training event on DI roles, responsibilities, and regulations in the human application sector. Enhance skills, updates, discussions, and collaboration with HTA. Improve good practices.
E N D
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 • 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
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
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