This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo in conjunction with an industry taskforce comprised of regulatory experts from IMDA's Regulatory and Quality Working Group. The development of the programme is supported by the Irish Medical Devices Association Skillnet and contracting organisation, the Irish Medical Devices Association, the IBEC group that represents the Medical Technology sector. The IMDA skillnet will also support the participation of 15 students undertaking the MSc. degree programme.
The course will enable Regulatory Affairs 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 MSc award at NFQ Level 9.
Programme objectives are:
•To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function as a regulatory affairs professional in the medical device industry and to be capable of an immediate contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
•To ensure that participants have sufficient skills and knowledge to employ appropriate advanced data analysing, synthesising, summarising and research skills in a regulatory environment.
•To ensure that participants can effectively communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
•To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.
•To ensure the participants can provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.
The programme consists of a two year part-time Level 9 MSc in Medical Technology Regulatory Affairs (90 credits). The programme shall be made available online using a combination of distance-learning / e-learning technologies and some face to face workshops for an overall blended learning approach. The educational elements will be provided by the Institute of Technology Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.
The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over 2-2.5 years. Three modules are delivered per semester. A dissertation (30ECTS) is also carried out over year 1 and year 2.