1 / 7

EU ODD Workshop on Serious Adverse Event and Reaction reporting 11 October 2011

EU ODD Workshop on Serious Adverse Event and Reaction reporting 11 October 2011. Aim of today’s workshop. To develop the criteria for serious adverse event and reaction reporting under the EU ODD To get input from stakeholders to ensure the reporting criteria are fit for purpose and clear.

chars
Download Presentation

EU ODD Workshop on Serious Adverse Event and Reaction reporting 11 October 2011

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. EU ODD Workshop on Serious Adverse Event and Reaction reporting 11 October 2011

  2. Aim of today’s workshop • To develop the criteria for serious adverse event and reaction reporting under the EU ODD • To get input from stakeholders to ensure the reporting criteria are fit for purpose and clear

  3. Update on implementing the Organ Donation Directive 11 October 2011 Imogen Swann

  4. The EU ODD – a brief recap • DIRECTIVE 2010/45/EU sets minimum standards that must be met across all Member States, ensuring the quality and safety of human organs for transplantation, with the aim of: • increasing organ availability; • enhancing the efficiency and accessibility of transplantation systems; • improving quality and safety • Must be implemented in Member States by August 2012 • HTA appointed as Competent Authority in the UK

  5. Where we are today... • DH drafted implementing Regulations (SI), which are going through committee stage • HTA & NHSBT have contributed to the policy decisions to inform the drafting • HTA has drafted a ‘Framework’ document to accompany the Regulations • NHSBT will assist HTA in certain functions

  6. National set-up pre organ donation directive National set-up post organ donation directive Human Tissue Authority – CA Framework – Inspections - Enforcement - Licensing National Health Service Blood and Transplant (NHSBT) • Commission services for organs from deceased • Allocate organs • Annual activity report • Investigate SAE/SAR NHSBT Assisted (delegated) CA functions) • Investigation of SAE/SARs • Data collection • Register of living donors • Annual activity report • European Exchange, and a licensed PO Procurement &Transplant centres 35-40 • Employ NORs & living donor co-ordinators • Transplant organs from deceased • Procure & transplant organs from the living • Procurement (living) &Transplant centres 35-40 Licensed for • Organ/donor characterisation • Retrieval • Preservation • Transport • Transplant • Commissioned Services • Transportation • Testing labs • National organ retrieval teams (NORS) • NHSBT • Employ ‘specialist nurse - organ donation’ (SN-ODs) x 280 • SN-ODs based in 12 regional offices Procurement - deceased Any UK hospital NHSBT licence

  7. www.hta.gov.uk http://twitter.com/HTA_UK http://www.Facebook.com/HumanTissueAuthority

More Related