Medical Technology Regulatory Affairs

Course Summary
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.

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.

Applications are made online via IT Sligo admission: https://www.itsligo.ie/onlinelearning/apply/apply-to-it-sligo/

Key Course Information
Applications are made online via IT Sligo admission: https://www.itsligo.ie/onlinelearning/apply/apply-to-it-sligo/???????
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.

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

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

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.

Applications for online programmes are accepted on the atu sligo website.

All programmes advertised will run subject to sufficient student numbers.

ATU sligo online has two intakes per year, the main one being in September with a smaller listing of programmes for January. For confirmation on start dates check www.itsligo.ie/online

For September, applications open from 1st February each year. Closing date for receipt of applications is 31st august.

For January, applications open from 1st November each year. Closing date for applications is mid-January.

The online application form requires personal details, previous qualifications, professional accreditations, employment history and a personal statement. We recommend collating all the necessary paperwork i.e. Transcripts of previous qualifications, academic certificates before you submit an application.

Once submitted, our admissions team will contact you to confirm eligibility and request copies of any previous qualifications.

Academic staff review every application and approve eligible candidates for the programme.

Admissions team will notify you if you are accepted onto the course and will request deposit to confirm your place.

Places are limited, so please apply early.

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.

90

Most of our online courses have about 2-3 hours of live lectures per week (but this can vary per programme). The rest of your study time consists of independent learning, communicating with your lecturers and classmates and carrying out assignments.

Live lectures normally take place between 6pm and 10pm, Monday to Thursday but this may vary depending on the availability of specific lecturers. If the Live Classroom scheduled times for the live online lectures do not suit you, recordings will be made available through Moodle and other accessible platforms. These recordings can be downloaded and watched later, at a time that suits you.

Please note, you may be required to take some time off work for the below:

• Exams Christmas Exams: 2 – 4 days in January each year. Summer Exams: 2 – 4 days in May each year.

• Workshops/Practical Classes: Approximately 2 – 4 days per year depending on the course you are studying. You will receive notification of the dates from your lecturer for each specific subject requirement.

During our Online & Flexible Learning Induction, you will meet with your Course Co-ordinator who will be available to answer any questions you might have, and they will give you your timetable for the upcoming academic year.

If you have any further questions, please contact our Admissions Team on admissions@itsligo.ie.

To help balance work, life, and online learning, it is important to understand the time that you will have to dedicate to your studies. This will help you to stay focused, reduce stress, and achieve your goals while also working full-time.

For part-time online or blended learning, it is recommended that you should try to allow for 5-6 hours per week per 5 credit module to your studies.

EU students: MSc €12,000. Individual modules €900. Dissertation €2,500.

Non EU fees: €18,000 for MSc

Anyone living / working outside of Ireland and the EU for over 3 years pays non-EU Fees

http://www.nuigalway.ie/student-fees/international/​

Contact the college for the next start date.

Career Opportunities
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.