HEALTH PRODUCTS REGULATORY AUTHORITY [ HPRA ]

Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace Dublin 2 - Ireland

Mr Cathal Brennan

cathal.brennan@hpra.ie +35316764971 Website

Involved in the following projects during the 3rd programme

3rd Health Programme (2014-2020)
facilitatinG the Authorisation of Preparation Process for blood and tissues and cells [GAPP]
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to a...
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
Start date: 01/05/2018 - End date: 30/04/2021

Call: Joint Actions 2016
Topic: Authorisation of preparation processes in blood and tissues and cells
3rd Health Programme (2014-2020)
Joint Market Surveillance Actions on medical devices intended to be re-sterilized focusing on information in the Instruction for use and validation data necessary for the re-sterilisation by the user [COENJA2014]
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropr...
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropriate checks on the characteristics of products placed in the European Market. This joint action (JA) includes further development and expanding the coordination between MS, joint inspections by the Competent Authorities (CAs) shall be part of the project.
This Joint Action of European CAs will improve the transparency in the medical device market regarding compliance of medical devices to be reprocessed. It shall be investigated if the instruction for use (IFU) of medical devices intended to be re-used and resterilized conforms and contains all necessary information for safe and adequate re-processing. This will also allow an actual overview of the market related to these products and detecting deficiencies regarding re-processing posing a serious hazard to safety.
The market surveillance JA also contains additional elements, besides review of the IFU and sections of the technical documentation, such as inspections of manufacturers and other relevant actors. The outcome may also result in joint enforcement actions by the respective MS to be coordinated if needed and adequate. Meetings shall support harmonizing the processes to achieve a uniform action and to discuss and publish the final report.

Start date: 01/11/2015 - End date: 30/04/2017

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Coordination and resource sharing between Member States
3rd Health Programme (2014-2020)
Vigiliance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation [VISTART]
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantati...
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantation. 7 core work-packages (WP) have been defined. WP4 will explore commonalities between vigilance reporting in these fields, identifying opportunities for harmonising procedures. WP5 will increase the sharing of vigilance information of didactic value in order to achieve higher standards of quality and safety across blood, tissues and cells, as well as defining regulatory principles for short and long term follow up of recipients of blood, tissues and cells that have been prepared with newly developed and validated processes. WP6 will focus on the development of common Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorization of blood and tissue establishments. The main objective is the identification of a common framework for the conduct of inspections of blood and tissue establishments, developing a common approach with sharing of procedures across MS. The educational profile, basic competencies and specific skills required by MS for the respective inspectors in these fields will be defined in WP7. This action will include a number of initiatives aimed at increasing the interaction between inspectors from different MS including inspector training, a framework for joint inspections by multi-MS teams (WP8), a pilot for regional inspections and the creation of an inter-MS (WP9) inspection system auditing programme. The impact of these activities will be greatly increased by virtue of their conduct across the fields of blood, tissues and cells and ART. Greater inter-MS circulation of tissues and cells will also be facilitated by this action through support for the harmonised implementation of the Single European Code (WP10) and its associated compendia of tissue establishments and tissue and cell products.
Start date: 10/10/2015 - End date: 09/02/2019

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Blood transfusion and tissue and cell transplantation Joint Action
3rd Health Programme (2014-2020)
Market surveillance of medical devices [JAMS]
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical device...
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical devices sector. A key aim is to improve coordination and help lower-resourced Member States develop skills and capacity in the market surveillance network. It will help to ensure consistent and proportionate approach across all Member States in manufacturer inspections and clinical process and resource development.

Methods will be developed as follows:
1. Manufacturer inspections:
• Develop methods, agreed tools and guidance’s for a joint, consistent and proactive approach
• Establish specific inspection scopes and objectives to complement those conducted by conformity assessment bodies
• Develop different approaches and focus to manufacturer inspections
• Develop and deliver collaborating mechanisms designed to maximize the efficiency and effectiveness of resource deployment
• Develop an inspector training course to provide inspectors with basic skills and establish an inspectors expert group for ongoing collaborative approaches
2. Clinical process and resource development:
• Establish communication platforms and protocols
• Establish current practices and identify development and/or training needs and evaluation of clinical data by authorities
• Identify and prioritise medical devices which require development of common specifications to define clinical criteria for safety and performance.

In harmonising the European market surveillance system detection and reduction in the occurrence of safety issues will lead to increased public health protection by ensuring that medical devices conform especially to the requirements relating to safety and performance.


Start date: 17/10/2016 - End date: 16/10/2019

Call: Health Programme Adhoc Call for invited (named) beneficiaries
Topic: Market surveillance of medical devices