European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



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Irish Paediatric Clinical Research Network (IPCRN) National Children's Research Centre (NCRC)

Evidence of collaboration with regulatory authorities Yes All interventiomal clinical trials will seek favourable opinion form the Irish Medicines Board The Clinical Research Project Manager is in regular contact with the IMB with regards to the implementation of regulatory guidelines
Capacity to provide competent consultation to regulatory authorities Yes
Formal meetings for clinical trials Yes Formal investigator and study management meetings are underway for the ezcema and allergy, emergency medicine, respiratory medicine, neonatology, endocrinology and BASELINE studies.
Training courses given over the last 2 years Yes The National Children's Research Centre also provides structured training programmes for PhD and MD students, including a GCP course, a Data Protection course and workshops on elements of paediatric research.
Training courses received over the last 2 years Yes GCP training course BC/CLIN data management system training Risk Management course Project Management course
Promotion of participation in clinical trials in countries with limited resources No
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