The HPRA recently (29 April 2014) hosted a clinical trials seminar for academic sponsors and investigators at its offices in Earlsfort Terrace, Dublin 2. This important initiative was aimed at enhancing awareness of the knowledge and skills required to be actively involved in conducting clinical trials in Ireland.
Following on from the success of a previous seminar in June 2012, the HPRA invited experienced investigators to present on different aspects of the clinical trials process including experience in making clinical trial applications, the Voluntary Harmonisation Procedure (VHP) and the management of a clinical trial.
Workshops were held on the following topics:
- Good Clinical Practice (GCP) requirements;
- Advanced therapy clinical trials;
- Investigational medicinal product (IMP) – quality requirements, safety reporting and protocol preparation.
There were over 70 participants including pharmacists, medical practitioners and site staff from academic centres. The IMB received very positive feedback and suggestions from those in attendance and these will be used in the planning for future events.
Further information on this and future events is available from clinical.trials@hpra.ie
Clinical Trials Seminar 2014 – Responses to Participants Queries.