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Institute of Technology Sligo

Medical Technology Regulatory Affairs - Online

Course Overview
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.

Course outline
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.

Entry requirements

Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences. Previous or current experience in regulatory affairs (minimum 2 years) may be taken into account in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.

Candidates who have completed modules in cognate programme areas may also enter the programme and gain exemptions as determined by the Programme Committee in accordance with Institute's guidelines. Cases will be assessed on an individual basis by the Programme Committee. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of IT Sligo and NUI Galway.

Duration

The programme is delivered over 2-2.5 years, part-time. Online

Number of credits

Careers or further progression

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs environment within the highly successful and growing Irish Medical Technology industry sector.

The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world's top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 Medtech companies being indigenous. The sector is expected to continue to grow as stated in December 2014 by the Director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily…. with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff.

Regulatory Affairs within the medical technology products sector is a relatively young, multidimensional profession that is international in scope. Operationally, a Regulatory Affairs professional is responsible for assuring that pertinent government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system. Given the evolving nature of international regulations, a regulatory affairs professional must continually grow their knowledge and skills to be effective and to advance in their careers.

Regulatory professionals at all career and experience levels are involved in activities throughout the product lifecycle, and most are involved to some degree in bridging the gap between regulatory-related functions and organization and business activities.

Further enquiries

Further Information:
tel: 071 931 8511
E-Mail: admissions@itsligo.ie

Find out more:
Prof. Terry Smith
T: 353 91 492 022
E: terry.smith@nuigalway.ie

Ms Mary Butler
Institute of Technology, Sligo
E: butler.mary@itsligo.ie

Subjects taught

Semester 1
EU Medical Technology Regulatory Affairs – Introduction 5
US Medical Technology Regulatory Affairs- Introduction 5
Technical Report Writing 5

Semester 2
Global Medical Technology Regulatory Affairs Introduction 5
Clinical Evaluation 5
Quality Management System 5

Semester 3
EU Medical Technology Regulatory Affairs – Advanced 5
US Medical Technology Regulatory Affairs- Advanced 5
Risk Management, Labelling & Promotion 5

Semester 4
Global Medical Technology Regulatory Affairs – Advanced 5
Design Assurance, Sterilisation and Biocompatability 5
Post Market Surveillance 5

Semester 5/6
Dissertation 30

Comment

Who teaches this course?
The programme will be delivered by academic staff from NUI Galway and It Sligo, with expertise in Regulatory Affairs, with guest lectures and workshops involving Regulatory Affairs experts from the Medical technology industry sector.

Assessment method

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions. The Research Project thesis will also be assessed.