First PEARRL ESRs on their regulatory secondment at the HPRA

Written by Niklas Köhl (ESR 1) & Felix Ditzinger (ESR 2)

As the first PEARRL Early Stage Researchers we had the exceptional opportunity of getting three months first-hand experience on the regulatory working procedures within the Health Products Regulatory Authority (HPRA) in Dublin.

During several training courses, regulatory topics such as the Common Technical Document, Interchangeable Medicines, Clinical Trials, Assessment of Product Information and Enforcement were explained by the assessors or officers who evaluate these kinds of cases on a daily basis. All of this training was part of the established training program at the HPRA.
Within two projects we learned a lot about the lifecycle of a medicinal product from the approval of the clinical trials to the initial authorisation of the product and post-authorisation variations. Application of our recently acquired skills and findings to current issues on the European market resulted in two comprehensive reports.
Moreover, we had the opportunity to discuss, with various team members, how to assess different types of applications, for example, to appreciate the difference between the assessment of a clinical trial application and that of an application for a new marketing authorisation. We also attended various team meetings where pharmaceutical issues on a range of topics were discussed. Since we both have completed internships in pharmaceutical companies before, it was interesting to learn more about the opinion and views from a competent authority perspective on the framework of European Medicine Legislations. Due to the outstanding support of our supervisors, who were flexible on the topics of our learning plan and always provided us with the necessary information, we were able to obtain a better understanding of the links between our work at the university and the regulations in place for medicinal products on the Irish and wider EU markets. The secondment at the regulatory agency was an important step for the Early Stage Researcher within the PEARRL network to become a Regulatory Scientist.

HPRA, Dublin

From left to right: Una Moore, Niklas Köhl, Pauline Murray, Felix Ditzinger, Lauren Varešlija, Jayne Crowe