Health Products Regulatory Authority (HPRA)

This week, we hosted a Veterinary Medicines Information Day for marketing authorisation holders. Our team shared key updates on legislation and regulations affecting veterinary medicines in Ireland. We also discussed our plans to improve our responsiveness and our focus on safeguarding the availability of veterinary medicines. Thank you to everyone who joined us online and in person. We provide information about the regulation of veterinary medicines on our website: https://lnkd.in/eeYZugE6 #VeterinaryMedicines 

Today we were delighted to host our second annual Patient Speaker Programme event at the HPRA. We were joined by members of Cancer Trials Ireland's Patient Consultants Committee who shared their experiences with us. This Patient Speaker Programme is an initiative developed as part of our Patient Forum. It helps ensure we continue to understand and incorporate patient perspectives in the work we do. For more information on the Patient Forum visit www.hpra.ie/patientforum

Health institutions that manufacture and use in-house IVDs are now required to notify us of their activities. To assist this, we have published a notification form and a supporting FAQ to answer common questions about this notification process. This includes: → Why notifications have to be submitted → How to submit a notification → What information to include For more information and to access the form and FAQ document see:  https://lnkd.in/eDcYNC8h

We have become aware of a safety issue relating to Defibtech AED pads.   Unauthorised labels have been applied to some affected pads. This could lead to expired AED pads being used.   If you have been supplied with these pads, please take urgent action and read the manufacturer’s Field Safety Notice linked on our website https://lnkd.in/e_B8K5KX

Sponsors are reminded that the deadline to transition clinical trials to the Clinical Trials Regulation (CTR) is fast approaching. We recommend that sponsors submit transition applications to CTIS without delay to ensure review and authorisation is complete before the final deadline of 30 January 2025. For further information and guidance see https://lnkd.in/dnUqAsp7 #ClinicalTrialsRegulation #ClinicalTrialsInformationSystem #CTIS

This year the HPRA is offering two different streams for our graduate programme. Find out more details about each below.   🔗 Stream 1: Medical Devices Here you will learn about how medical devices are placed on the market and how they are maintained through their lifecycle. You will also learn about their different legal requirements. https://lnkd.in/ePMMXSks 🔗 Stream 2: Medicines on our Market Here you will learn about how we monitor the safety of medicines and the regulations that impact how they are distributed and manufactured.  https://lnkd.in/e2UcAsvx

We were delighted to participate in the Medtech Advance workshop hosted by the HRB National Clinical Trials Office (NCTO) this week.   Our Medical Devices team took part in the event to communicate to commercial and academic sponsors of clinical investigations about the supports we offer.   We offer preliminary and pre-submission meetings to outline the regulatory requirements and answer any queries before applying to run a clinical investigation.   We invite manufacturers, medical device innovators and both clinical and academic sponsors to request a meeting with us.   For further information: https://lnkd.in/e5fYrUzt 

And we're off! A fantastic start to the Medtech Advance workshop! So far this morning we'd had fantastic speakers such as Dr. Donal O'Connor of the Health Products Regulatory Authority (HPRA), Ronan Rodgers and John Kilmartin of Medtronic, Dr. Emer Sherry of Irish Medtech and many more to come. We're truly greatful and delighted to welcome so many leading experts to share their knowledge and expertise! #networking #Medtech Enterprise Ireland, Health Research Board (HRB), National Office for Research Ethics Committees

We’re at Stand 8  today at the gradireland Careers Fair in the RDS. Come visit us to find out about our graduate programme and have a chance to speak to some past graduates. Look forward to seeing you! Visit www.hpra.ie/grad for more information about our programme. #gradfair24 #gradireland#gradprogramme

The following roles are now open for applications: - Education Development Specialist – Digital Learning - Human Products Authorisation and Registration (the closing date for application is 20/10/2024) - Planning and Authorisations Manager, Planning and Authorisations – Veterinary Sciences (the closing date for application is 13/10/2024) Please see the link to the full job description details below https://lnkd.in/gqfjXeD To apply please send your CV and completed application form to jobs@hpra.ie