Featured courseFundamentals in Regulatory Affairs (Level 8 on NFQ)
23 24 Mar, 6 7 April, 27 28 April, 11 12 May, 26 27 (Sat) May, 8 9 June
Fundamentals in Regulatory Affairs
This programme has been designed to meet the growing requirements of Irish companies in filling regulatory assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a taskforce comprised of regulatory experts from Irish Medtech Association’s Regulatory and Quality Working Group. In particular, this industry led programme will assist companies as they prepare for the new EU regulatory framework and offer unique flexibility to companies to adapt rapidly to changing regulatory workloads ahead of the entry into force of the new EU Medical Device and IVD Medical Device Regulations.The course will enable personnel in the medical technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive an award of 9 ECTS at NFQ Level 8.