Written by Sandra Jankovic (ESR 5) & Laura Henze (ESR 9)
As part of PEARRL we had the opportunity of getting three months experience in the regulatory environment within the Health Products Regulatory Authority (HPRA) in Dublin. HPRA is the national competent authority that regulates human medicines, veterinary medicines, medical devices and other health products in Ireland. We were the second PEARRL students in the HPRA after Felix Ditzinger and Niklas Koehl, who worked at the HPRA at the beginning of this year.
As part of PEARRL we had the opportunity of getting three months experience in the regulatory environment within the Health Products Regulatory Authority (HPRA) in Dublin. HPRA is the national competent authority that regulates human medicines, veterinary medicines, medical devices and other health products in Ireland. We were the second PEARRL students in the HPRA after Felix Ditzinger and Niklas Koehl, who worked at the HPRA at the beginning of this year.
During the three months we were at the HPRA, we were based in the Pharmaceutical Assessment Team. We were supported by our supervisors in our day to day work and able to join various team meetings where several pharmaceutical topics were discussed. Furthermore, we were involved in two projects, in collaboration with two Sections with the Human Products Authorisation and Registration Department: Clinical Assessment & Pharmaceutical Assessment. We analysed internal HPRA databases and presented our findings to the relevant teams.
Overall, we got an impressive insight into regulatory procedures for medicines. We were able to join, not only the internal training program of the Pharmaceutical Assessment Section focusing on interchangeable medicines, variations, renewals & clinical trial applications, but also several training courses from different departments within the HPRA such as the Veterinary Science and the Pharmacovigilance & Risk Management Departments. We were then able to implement our knowledge through the assessment of Product Information and renewals for marketing authorisations of human medicinal products.
As PEARRL brings together a multi-national network of European Pharma Industry, Academia and the Regulatory Agencies, it gives all Early Stage Researchers the opportunity to get familiar with each area and be trained on various innovative topics. The regulatory environment was a completely new world for us - during team meetings we were able to get a deeper insight into the risk-benefit evaluation involved in the pre and post-licensing activities for medicinal products and its importance in the protection of public health.
Thanks to the support of our supervisors we were able to gain a deeper understanding of the pharmaceutical regulatory activities, not only within the Irish market, but also throughout the European Regulatory framework. Despite our short stay at the HPRA, it was a great experience and an essential piece in our future careers, perhaps as Regulatory Scientists!
Overall, we got an impressive insight into regulatory procedures for medicines. We were able to join, not only the internal training program of the Pharmaceutical Assessment Section focusing on interchangeable medicines, variations, renewals & clinical trial applications, but also several training courses from different departments within the HPRA such as the Veterinary Science and the Pharmacovigilance & Risk Management Departments. We were then able to implement our knowledge through the assessment of Product Information and renewals for marketing authorisations of human medicinal products.
As PEARRL brings together a multi-national network of European Pharma Industry, Academia and the Regulatory Agencies, it gives all Early Stage Researchers the opportunity to get familiar with each area and be trained on various innovative topics. The regulatory environment was a completely new world for us - during team meetings we were able to get a deeper insight into the risk-benefit evaluation involved in the pre and post-licensing activities for medicinal products and its importance in the protection of public health.
Thanks to the support of our supervisors we were able to gain a deeper understanding of the pharmaceutical regulatory activities, not only within the Irish market, but also throughout the European Regulatory framework. Despite our short stay at the HPRA, it was a great experience and an essential piece in our future careers, perhaps as Regulatory Scientists!
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