Health Products Regulatory Authority (HPRA)

The following role is now open for applications: - GMP Inspector - Inspections, Compliance Please see the link to the full job description details below https://lnkd.in/gqfjXeD The closing date for application is 19/01/2025 Táthar ag glacadh le hiarratais anois don ról seo a leanas: - Cigire Dea-Chleachtais Monaraíochta (GMP) - Cigireachtaí, Comhlíonadh Féach ar an nasc thíos do shonraí iomlána an tsainchuntais poist https://lnkd.in/gqfjXeD Is é 19/01/2025 an dáta deiridh a nglacfar le hiarratais

We are inviting you to participate in our public consultation on the development of our 2026 – 2028 Strategy. The consultation is an opportunity for you to help shape our organisation’s future direction and role in the regulatory landscape. Your feedback will help us assess our current strategy to highlight opportunities for improvement and identify emerging priorities in the regulatory environment. You can participate by completing the survey which is open until 17 January 2025. For more information and to complete the survey see: https://lnkd.in/e-Beb-TZ

The following role is now open for applications: - Interim National Licensing Manager - Human Products Authorisation & Registration Please see the link to the full job description details below https://lnkd.in/gqfjXeD The closing date for application is 08/01/2025 12:00pm

The following role is now open for applications: - Scientific Officer, Pharmaceutical Assessment – Veterinary Sciences Please see the link to the full job description details below https://lnkd.in/gqfjXeD The closing date for application is 12/01/2025 Táthar ag glacadh le hiarratais anois don ról seo a leanas: - Oifigeach Eolaíochta - Measúnú Cógaisíochta - Na hEolaíochtaí Tréidliachta Féach ar an nasc thíos do shonraí iomlána an tsainchuntais poist https://lnkd.in/gqfjXeD Is é 12/01/2025 an dáta deiridh a nglacfar le hiarratais

Due to late cancellations, we have a limited number of DCP slots available in January and February 2025 for the submission of suitable generic applications. If you have high-quality and complete dossiers ready for submission, we encourage you to submit an RMS request application. We aim to respond to your request as soon as possible. To find out how to submit an RMS request application, see our guide: https://lnkd.in/epnWXqwx

✨ Exciting news for developers of innovative therapies! Member State authorities have endorsed the COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme spans seven cross-sector projects to be rolled out over the coming years, focusing on: ✅ Piloting a single assessment process for multi-country combined studies under device and medicinal product regulations. ✅ Harmonizing serious adverse event reporting processes. ✅ Clarifying the interface between clinical trials and medical device regulations. ✅ Exploring ways to advise sponsors and foster knowledge exchange among national authorities. By fostering collaboration in an inclusive framework, the COMBINE programme brings together competent authorities for clinical trials and medical devices, the European Commission, the European Medicines Agency, ethics committees and key stakeholders like sponsors, clinicians, and patient representatives. 🔗 Learn more about the strategy here: https://lnkd.in/gV8Kya8m #HealthUnion

Today we were delighted to welcome back the members of our Patient Forum for our last meeting of the year. Colleagues from the PSI–The Pharmacy Regulator also joined us for the discussions. We focused on objectives for next year and looked at what key topics would be most effective for our workplan in 2025. This forum is an invaluable platform for us at the HPRA and we would like to thank all our members for their great contributions this year. We look forward to working together next year.

Our latest Drug Safety Newsletter provides healthcare professionals with information for using medicines safely and effectively. This edition includes: → Updates on pregnancy outcomes with fluconazole and advice for women who could become pregnant → EU review begins on the link between suicidal thoughts and behaviours with finasteride and dutasteride → Higher risk of atrial fibrillation in patients with heart disease or risk factors when using Omega-3-acid ethyl esters Download the newsletter: https://lnkd.in/eGF_JfNB

We are looking for Clinical Assessors to join our team in the areas of centralised marketing authorisations and clinical trials. As a Clinical Assessor within the area of human medicines regulation, your role is vital to the evaluation of medicines, ensuring their safety and efficacy for patient care. Working within the European medicines regulatory network, you will be at the forefront of advances in drug development, technological, and scientific innovations across diverse therapeutic areas, with opportunities to collaborate and partner with experts within our organisation and across the EU. - Assessor, Clinical Assessment (Centralised Medicines) - Human Products Authorisation and Registration The closing date for application is 8/12/2024 - Assessor, Clinical Assessment (Clinical Trials) - Human Products Authorisation and Registration The closing date for application is 4/12/2024 Please see the link to the full job description details below https://lnkd.in/gqfjXeD

📢 The European Shortages Monitoring Platform (#ESMP) is live! The platform is now available to marketing authorisation holders, who will be able to submit data on shortages of centrally authorised human medicines in the ESMP. ESMP is an important regulatory tool that will: 🔸 gather comprehensive information on the availability, supply and demand of human medicines 🔸 help to detect, prevent and manage shortages in the EU and the EEA 🔸 facilitate communication between EMA, national competent authorities and industry to ensure medicines are available for those who need them.   Learn more about what’s next for ESMP from our news announcement (link in comments). #publichealth #shortages #medicines #healthunion