Irish Health Organisations
http://hdl.handle.net/10147/42489
2024-03-29T10:56:53ZBrexit Guide for Stakeholders Organisations Responsible for Human Application of Tissues and Cells - Hospitals
http://hdl.handle.net/10147/641318
Brexit Guide for Stakeholders Organisations Responsible for Human Application of Tissues and Cells - Hospitals
Health Products Regulatory Authority (HPRA)
As the UK will become a third country, following Brexit, we would like to draw your attention to the fact that import of tissues into Ireland from outside of the European Union (EU), i.e. a third country, must only take place under an authorisation by the HPRA. There is still uncertainty surrounding the content of the withdrawal agreement, but stakeholders should be prepared. It is important to consider the impact Brexit may have on your supply of tissues and cells.
The recently published Directive 2015/566 is an implementing Directive of 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells. It has been transposed into Irish legislation as S.I. No. 33 of 2019 European Communities (quality and safety of human tissues and cells) (amendment) Regulations 2019.
This legislation sets out the specific requirements in relation to an importing tissue establishment (ITE) authorisation, which is a requirement when importing tissues or cells from a supplier outside of the EU.
2020-11-20T00:00:00ZGuide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP)
http://hdl.handle.net/10147/641317
Guide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP)
Health Products Regulatory Authority (HPRA); National Office for Research Ethics Committee
The Clinical Trials Regulation-National Collaboration Project is a joint undertaking by the HPRA and the National Office for Research Ethics Committee (the National Office) to facilitate preparation for the implementation of the new Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014). The HPRA, the National Office, and sponsors of clinical trials will participate in the Collaboration Project to gain experience that will facilitate the implementation of the CTR in Ireland.
The CTR aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, across the EU. Intrinsic to this is the simplification of current rules. The CTR will impact the way that sponsors submit clinical trial documentation, and how the competent authority (the HPRA) and the NREC-CT review and approve clinical trials.
2021-03-29T00:00:00ZGuide to Good Distribution Practice of Medicinal Products for Human Use
http://hdl.handle.net/10147/641316
Guide to Good Distribution Practice of Medicinal Products for Human Use
Health Products Regulatory Authority (HPRA)
The purpose of this document is to provide additional clarification to wholesalers and brokers located in Ireland regarding the Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01). These guidelines, published by the European Commission, became effective on 8 September 2013. Due to some typographical errors in the guidelines, an updated version was published, Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), available on the European Commission website, (hereafter referred to as ‘the guidelines’).
Good distribution practice (GDP) requirements clearly outlined in the guidelines are not repeated within this guidance document as the requirements are deemed to be self-explanatory and do not need additional clarification within this document. Wholesalers should ensure that they comply in full with all requirements of both the guidelines and this HPRA guidance document. Wholesalers should ensure that documentation is made available to the HPRA to verify compliance with GDP requirements, when requested.
The licensing authority for the wholesaling of medicinal products for veterinary use is the Department of Agriculture, Food and the Marine; this guide does not relate to the wholesale of veterinary medicinal products.
For companies wishing to apply for a wholesale distribution authorisation (WDA) or to register as a broker, please refer to ‘Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland’ available in the ‘Publications and Forms’ section at www.hpra.ie.
2021-03-09T00:00:00ZMetagenomic assembled plasmids of the human microbiome vary across disease cohorts.
http://hdl.handle.net/10147/641315
Metagenomic assembled plasmids of the human microbiome vary across disease cohorts.
Harrington, R S; Khokhlova, E V; Daly, K M; McDonnell, S A; O'Reagan, O; Nolan, J A; Sheehan, D; Lavelle, A; Draper, L A; Ross, R P; Stockdale, Stephen; Hill, Colin; Shanahan, Fergus; Shkoporov, Andrey
We compiled a human metagenome assembled plasmid (MAP) database and interrogated differences across multiple studies that were originally designed to investigate the composition of the human microbiome across various lifestyles, life stages and events. This was performed as plasmids enable bacteria to rapidly expand their functional capacity through mobilisation, yet their contribution to human health and disease is poorly understood. We observed that inter-sample β-diversity differences of plasmid content (plasmidome) could distinguish cohorts across a multitude of conditions. We also show that reduced intra-sample plasmidome α-diversity is consistent amongst patients with inflammatory bowel disease (IBD) and Clostridioides difficile infections. We also show that faecal microbiota transplants can restore plasmidome diversity. Overall plasmidome diversity, specific plasmids, and plasmid-encoded functions can all potentially act as biomarkers of IBD or its severity. The human plasmidome is an overlooked facet of the microbiome and should be integrated into investigations regarding the role of the microbiome in promoting health or disease. Including MAP databases in analyses will enable a greater understanding of the roles of plasmid-encoded functions within the gut microbiome and will inform future human metagenome analyses.
2022-06-02T00:00:00ZGuide to Performance Studies Conducted in Ireland
http://hdl.handle.net/10147/641310
Guide to Performance Studies Conducted in Ireland
Health Products Regulatory Authority (HPRA)
The purpose of this guide is to provide an overview of legislation and key concepts relevant to performance studies (PS) involving in vitro diagnostic medical devices (IVDs). In addition, information is provided on how to submit applications or notifications to the Health Products Regulatory Authority (HPRA).
This guide is targeted at PS sponsors (e.g. manufacturers, academic groups, clinical research organisations) who wish to conduct PS involving IVDs in Ireland. The information may also prove useful for ethics committees and other stakeholders.
This guidance does not purport to be the definite interpretation of the law and/or regulations and is for guidance purposes only. Relevant legislation relating to in vitro diagnostic medical devices should be consulted in addition to this guide.
2022-06-15T00:00:00ZInspectorate of Mental Health Services: Child And Adolescent Mental Health Services 2013: Admissions of Children to Adult Units In 2013
http://hdl.handle.net/10147/641309
Inspectorate of Mental Health Services: Child And Adolescent Mental Health Services 2013: Admissions of Children to Adult Units In 2013
Mental Health Commission (MHC)
The Inspectorate of Mental Health Services remains concerned about the high number of children being admitted to adult in-patient units, although this number has decreased since 2009. In 2013 there were 91 admissions to adult units, relating to 83 children. A Vision for Change (2006) recommended that mental health in-patient services for children up to the age of 18 years be provided by dedicated child and adolescent in-patient units. Up until then, the majority of children aged 16 to 17 years were admitted to adult in-patient units.
2014-06-05T00:00:00ZAudit of Risk Assessment in Approved Centres in 2013
http://hdl.handle.net/10147/641308
Audit of Risk Assessment in Approved Centres in 2013
Mental Health Commission (MHC)
In 2013, a brief audit of risk assessment in a number of approved centres nationally was carried out by the Inspectorate during the course of inspections. As part of the inspection process, inspectors completed a short template which identified a number of issues related to risk assessment.
2014-06-05T00:00:00ZInspectorate of mental health services: a review of 24-hour supervised residences 2009-2013
http://hdl.handle.net/10147/641307
Inspectorate of mental health services: a review of 24-hour supervised residences 2009-2013
Finnerty, Susan
In 2005 the Inspectorate inspected all 24-hour supervised residences under the care
of the mental health services, of which there were 127. The list of these residences
was provided by the Health Service Executive.
The main findings of inspections of these 24-hour supervised residences in 2005
were:
There were approximately 1700 residents in 24-hour supervised residences.
There were only a small number under the care of rehabilitation and recovery
teams (only six teams nationally).
There was a lack of available accommodation for residents who were ready to
be discharged from 24-hour supervised residences.
The majority of residences were too large, having up to 20 residents, some
with up to 30 residents.
A significant number were located in isolated areas.
There was little input from the multidisciplinary team.
Establishment of these residences was related to hospital closure rather than
rehabilitation.
In conclusion, the majority were long-stay wards in the community.
2014-06-05T00:00:00ZApproved Centre Inspection Report: Avonmore & Glencree Units, Newcastle Hospital 14 – 1 6 March 2017
http://hdl.handle.net/10147/641305
Approved Centre Inspection Report: Avonmore & Glencree Units, Newcastle Hospital 14 – 1 6 March 2017
Mental Health Commission (MHC)
Section 51(1)(a) of the Mental Health Act 2001 (the 2001 Act) states that the principal function of the Inspector shall be to “visit and inspect every approved centre at least once a year in which the commencement of this section falls and to visit and inspect any other premises where mental health services are being provided as he or she thinks appropriate”.
Each approved centre will be assessed against all regulations, rules, codes of practice, and Part 4 of the 2001 Act as applicable, at least once on an annual basis. Inspectors will use the triangulation process of documentation review, observation and interview to assess compliance with the requirements. Where non-compliance is determined, the risk level of the non-compliance will be assessed.
2018-07-30T00:00:00ZApproved Centre Inspection Report: Avonmore & Glencree Units, Newcastle Hospital 5 – 8 February 2019
http://hdl.handle.net/10147/641303
Approved Centre Inspection Report: Avonmore & Glencree Units, Newcastle Hospital 5 – 8 February 2019
Mental Health Commission (MHC)
The approved centre was located on the outskirts of Newtownmountkennedy, Co. Wicklow. It comprised of two wards in single storey style, with an activities centre located in the grounds. Glencree Ward, the acute admission unit had capacity for 26 residents. Five sector teams Psychiatry of Old Age and a Mental Health Intellectual Disability team had admitting rights to the approved centre. Avonmore Ward provided continuing care and a long stay facility, with capacity for 26 residents. It also provided assessment and treatment for residents aged over 65 years from the Psychiatry of Old Age team or any of the sector teams.
Compliance with regulations, rules and codes of practice had decreased from 77% in 2018 to 69% in this inspection (2019). Seven (64%) of these non-compliances were rated as high risk, including a breach of Part 4 of the Mental Health Act 2001. Ten individual areas of compliance with regulations were rated excellent.
2019-10-22T00:00:00Z