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Courses Courses Choosing a course is one of the most important decisions you'll ever make! View our courses and see what our students and lecturers have to say about the courses you are interested in at the links below. University Life University Life Each year more than 4,000 choose NUI Galway as their University of choice. Find out what life at NUI Galway is all about here. About NUI Galway About NUI Galway Since 1845, NUI Galway has been sharing the highest quality teaching and research with Ireland and the world. Find out what makes our University so special – from our distinguished history to the latest news and campus developments. Colleges & Schools Colleges & Schools NUI Galway has earned international recognition as a research-led university with a commitment to top quality teaching across a range of key areas of expertise. Research Research NUI Galway’s vibrant research community take on some of the most pressing challenges of our times. Business & Industry Guiding Breakthrough Research at NUI Galway We explore and facilitate commercial opportunities for the research community at NUI Galway, as well as facilitating industry partnership. Alumni, Friends & Supporters Alumni, Friends & Supporters There are over 90,000 NUI Galway graduates Worldwide, connect with us and tap into the online community. Community Engagement Community Engagement At NUI Galway, we believe that the best learning takes place when you apply what you learn in a real world context. That's why many of our courses include work placements or community projects. Medical Technology Regulatory Affairs and Quality (Higher Diploma) Expand all Course Overview The Level 8 Higher Diploma in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional. The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality. The Higher Diploma in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of 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 external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards. The course will link the existing regulations to regulatory requirements and how those requirements are executed across the medical device lifecycle, for example; how to develop technical documentation for regulatory submissions (regulatory affairs professionals), how to perform vigilance post market surveillance requirements (Vigilance specialist), core quality management standards and requirements (QA or Compliance Specialist) and testing requirements to demonstrate safety and efficacy of a medical device (R&D Engineer). Regulatory Affairs and Quality personnel within the medical technology products sector are 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 healthcare system. Given the evolving nature of international regulations regulatory affairs and quality assurance professionals must continually grow their knowledge and skills to be effective and to advance in their careers. This course will ensure the development and enhancement of those skills. The programme aims are to: - Provide participants with a fundamental grounding in medical device regulatory and quality requirements. - Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles. - To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment - Foster participants’ intellectual development and develop skills to work and communicate effectively through various media - 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 appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world. The course will enable Regulatory Affairs and Quality Assurance 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 and Quality Assurance. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits. Upon successful completion of the programme, participants receive an NFQ Level 8 Higher Diploma award of 60 credits. Applications and Selections Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme. International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test e.g. IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent. International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation. Who Teaches this Course The programme will be delivered by academic staff from NUI Galway and IT Sligo, with expertise in Regulatory Affairs and Quality, with guest lectures and workshops involving Regulatory Affairs experts and practitioners from the Medical technology industry sector. The staff associated with the programme development and delivery include: - Prof. Terry Smith (NUI Galway)—Co-Director - Ms Mary Butler (IT Sligo)—Co-Director - Ms Deidre Barrow (Med Tech Regulatory Affairs Consultant)—Lecturer - Dr Olivia McDermott (NUI Galway)— Lecturer - Dr Sandra Ganly (NUI Galway)—Lecturer - Dr Stephen Daly (IT Sligo)—Lecturer - Dr Ailish Breen (IT Sligo)—Lecturer - Dr Mary Garvey (IT Sligo)—Lecturer - Dr Yvonne Lang (IT Sligo) – Lecturer - Dr Tom Patton (IT Sligo) - Dr Colin Fowley (IT Sligo) Requirements and Assessment Key Facts Entry Requirements Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates’ suitability for the programme. International students, whose first language is not English, will be required to prove their English competency through their school leaving examination or matriculation examination or by achieving the minimum standard in a recognised English language test e.g. IELTS English language proficiency of 6.5 (with no band less than 6.0 in each element of the test) or equivalent. International students, whose first language is not English, will also need to provide evidence of their oral communication skills at interview. In addition to demonstrating their English language competency, they will need to provide evidence of having relevant experience in research (laboratory and/or computational desk based research) at undergraduate level or post-graduation. Additional Requirements Duration 2 years, part-time Next start date September 2018 A Level Grades () Average intake Closing Date 17 August 2018 Next start date September 2018 NFQ level Level 8 Mode of study PART-TIME—online distance learning ECTS weighting Award CAO PAC code Course Outline The Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality is a two year part-time programme (60 credits). The programme is made available online using a combination of distance-learning / e-learning technologies, with some optional workshops. The educational elements are provided by NUI Galway and Institute of Technology Sligo staff. Additional lecturing, as required, may be provided by industry specialists and practitioners. The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester. 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. Year 1 Semester 1 Modules (each module is 5 ECTS) - Introduction to Quality Management Systems - Fundamentals of EU Medical Device Regulations - Auditing and Compliance Semester 2 Modules (each module is 5 ECTS) - Fundamentals of US Medical Device Regulations - Risk Assessment - Validation and Calibration Year 2 Semester 3 Modules (each module is 5 ECTS) - Fundamentals of Global Medical Device Regulations - Sterilisation & Biocompatability - Operations Management. and GMP Semester 4 Modules (each module is 5 ECTS) - Fundamentals of Medical Device Clinical Trials - Introduction to Market Vigilance & Labelling - Technical Report Writing Further EducationFollowing completion of the Higher Diploma (60 credits) students are eligible to apply to undertake the MSc in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI Galway and IT Sligo. Why Choose This Course? Career Opportunities This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector, with over 30,000 people currently employed. It has been specifically designed to meet the growing requirements of 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 in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west. The Irish Medtech Association (IMA) Skillnet asked senior MedTech industry executives to identify the current number of employees required to meet current skills demand, as well as forecasted number of employees required in MedTech organisations up to 2020. The IMA report (2017) has estimated that 4,000 additional Medical Technologies jobs will be added by 2020, with a 43% increase in staff numbers in the regulatory affairs functions and 17% in Quality roles. Who’s Suited to This Course Learning Outcomes Work Placement Study Abroad Related Student Organisations Course Fees Fees: EU Fees: Tuition Fees: Student levy Fees: Non EU Find out More Course Co-Director: Prof. Terry Smith E: terry.smith@nuigalway.ie Course Co-Director: Ms Mary Butler E: butler.mary@itsligo.ie Lecturer and Quality and Regulatory Affairs Expert: Dr Olivia McDermott E: Olivia.mcdermott@nuigalway.ie Lecturer and Medical Technology Regulatory Affairs consultant: Deirdre Barrow E: Barrow.Deirdre@itsligo.ie
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Courses Courses Choosing a course is one of the most important decisions you'll ever make! View our courses and see what our students and lecturers have to say about the courses you are interested in at the links below. University Life University Life Each year more than 4,000 choose NUI Galway as their University of choice. Find out what life at NUI Galway is all about here. About NUI Galway About NUI Galway Since 1845, NUI Galway has been sharing the highest quality teaching and research with Ireland and the world. Find out what makes our University so special – from our distinguished history to the latest news and campus developments. Colleges & Schools Colleges & Schools NUI Galway has earned international recognition as a research-led university with a commitment to top quality teaching across a range of key areas of expertise. Research Research NUI Galway’s vibrant research community take on some of the most pressing challenges of our times. Business & Industry Guiding Breakthrough Research at NUI Galway We explore and facilitate commercial opportunities for the research community at NUI Galway, as well as facilitating industry partnership. Alumni, Friends & Supporters Alumni, Friends & Supporters There are over 90,000 NUI Galway graduates Worldwide, connect with us and tap into the online community. Community Engagement Community Engagement At NUI Galway, we believe that the best learning takes place when you apply what you learn in a real world context. That's why many of our courses include work placements or community projects. Cleachtas Gairmiúil sna Meáin (MA/Diop) Expand all Course Overview Páirtnéireacht eisceachtúil idir Ollscoil na hÉireann, Gaillimh agus Raidió Teilifís Éireann is ea an MA (Cleachtas Gairmiúil sna Meáin) atá á chur ar fáil trí mheán na Gaeilge ag Acadamh na hOllscolaíochta Gaeilge san Ollscoil. Faoin bpáirtnéireacht seo, déanfaidh tú staidéar agus anailís chriticiúil ar na meáin agus ar chruinnscríobh na Gaeilge san Ollscoil agus ar líne; agus déanfaidh tú staidéar ar chleachtais ghairmiúla chomhaimseartha sna meáin in aonaid Ghaeilge éagsúla de chuid RTÉ i gConamara agus i mBaile Átha Cliath. Cur chuige nuálach agus tarraingteach é seo: beidh deis agat tréimhsí suntasacha a chaitheamh ar láithreacha oibre RTÉ le linn an chláir, ní mar ghnáth-intéirneach, ach mar mhac léinn a bheidh faoi stiúir acadúil leanúnach. Ar an gcaoi sin gheobhaidh tú taithí luachmhar san iriseoireacht, sa chraoltóireacht, agus i gcruthú ábhair d'ardáin ilmheán, agus tú ag feidhmiú mar 'chleachtóir machnamhach' sa mhórchraoltóir náisiúnta. Tá an clár 90 ECTS seo ar fáil in imeacht aon bhliain amháin (lánaimseartha) nó go páirtaimseartha in imeacht dhá bhliain. Is féidir tabhairt faoin gclár ar bhonn modúil. Beidh mic léinn i dteideal na cáilíochta Dioplóma Iarchéime ach 60 ECTS a bhaint amach sa chlár múinte, nó dul ar aghaidh agus an cháilíocht Máistir i gCleachtas Gairmiúil sna Meáin a bhaint trí thionscadal taighde féinstiúrtha a chur i gcrích go sásúil agus na creidiúintí 90 ECTS a bhaint. Láithreacha an Chláir Reáchtálfar an clár trí mheán na Gaeilge in ionaid éagsúla de chuid OÉ, Gaillimh, agus go cianda tríd an bhfoghlaim chumaisc. Sa chéad seimeastar beidh tú lonnaithe san iarthar: ar champais OÉ, Gaillimh; i stiúideonna RTÉ Raidió na Gaeltachta; agus i stiúideo nuachta RTÉ i mBaile na hAbhann. (Ag brath ar éileamh, d’fhéadfá a bheith lonnaithe ar feadh tréimhse i stiúideonna RTÉ Raidió na Gaeltachta i gCasla, sna Doirí Beaga nó i mBaile na nGall, de réir mar a fheileann.) Sa dara seimeastar beidh tú lonnaithe in oirthear na tíre, in aonaid Ghaeilge éagsúla de chuid RTÉ i nDomhnach Broc, Baile Átha Cliath. Sa tríú seimeastar cuirfidh tú tionscadal taighde féinstiúrtha (tráchtas scríofa nó tionscadal taighde praiticbhunaithe) i gcrích as láithreacha éagsúla. Mar chuid den fhoghlaim chumaisc agus ar líne cuirfear ceardlanna rialta ar fáil. Líon na Mac Léinn Beidh cúig áit déag ar a mhéid ar tairiscint in aghaidh na bliana. Deiseanna Staidéir Breise Beidh deis ag céimithe an chláir tabhairt faoi chlár taighde dochtúireachta sna Meáin, sna hEalaíona, sna Daonnachtaí agus sa Ghaeilge. Aidhmeanna agus Cuspóirí an Chláir - Staidéar a dhéanamh ar na comhthéacsanna agus ar na suíomhanna éagsúla ina bhfeidhmíonn na meáin chomhaimseartha d'fhonn anailís chriticiúil a dhéanamh ar a ról i múnlú na n-acmhainní siombalacha trína dtagann daoine ar thuiscintí faoin tsochaí mórthimpeall orthu. - Foghlaim ar an láthair oibre a chur ar fáil do mhic léinn maidir le cleachtais ghairmiúla iriseoirí, craoltóirí agus cruthaitheoirí ábhar ilmheán, d’fhonn tuiscint ghrinn agus taithí a thabhairt dóibh ar chleachtais ghairmiúla sna meáin chomhaimseartha. - Sintéis éifeachtach idir an teoiric agus an phraitic a aimsiú d'fhonn forbairt intleachtúil, acadúil agus ghairmiúil na mac léinn mar ‘chleachtóirí machnamhacha’ a chur chun cinn. - Cur le cumas an mhic léinn é/í féin a chur in iúl agus i láthair go héifeachtach agus go húdarásach trí mheán na Gaeilge ag imeachtaí poiblí agus os comhair ceamara nó micreafóin. Torthaí Foghlama an Chláir Ar chríochnú an chláir go sásúil, beidh an mac léinn in ann: - Anailís a dhéanamh ar théacsanna meán agus ar ról na meán sa tsochaí; - Machnamh cruthaitheach a dhéanamh ar choincheapa scéalaíochta agus ábhair; - Léargas grinn a thabhairt, agus anailís chriticiúil a dhéanamh, ar chleachtais ghairmiúla iriseoirí, craoltóirí agus cruthaitheoirí ábhar ilmheán; - Ceisteanna eitice sna meáin chomhaimseartha a scrúdú agus a phlé go húdarásach; - Dioscúrsaí éagsúla a chur i láthair, a scrúdú, a cheistiú agus a phlé trí mheán na Gaeilge sa stiúideo teilifíse agus raidió, agus ag ócáidí poiblí; - Inniúlacht ar scileanna iriseoireachta, craoltóireachta agus cruthú ábhair a léiriú; - Tionscadal taighde féinstiúrtha a phleanáil, a dhearadh, a fhorbairt agus a chur i gcrích. Tréithe Céimithe an Chláir Ar thréithe céimithe an chláir beidh an cumas intleachtúil agus anailíse le léargas criticiúil a thabhairt ar na cúinsí sóisialta, eacnamaíocha, polaitiúla agus cultúrtha faoina bhfeidhmíonn na meáin sa tsochaí chomhaimseartha; chomh maith leis an gcruthaitheacht, an fhiosracht, an ghéarchúis, an fhísiúlacht agus an tsamhlaíocht atá ag teastáil le dul chun cinn suntasach a dhéanamh mar chleachtóirí machnamhacha sna meáin agus in earnálacha gaolmhara sa lá atá inniu ann. Anuas air sin déanfar a gcuid luachanna, eolas agus scileanna a chothú agus a fhorbairt. Applications and Selections Who Teaches this Course - An Dr. Uinsionn Mac Dubhghaill, BA, MA, PhD, A.Diop. in Oid. - Aodh Ó Coileáin, BA, LLB, LLM - Seán Breathnach BA, MA, A.Diop. i gCumarsáid Fheidhmeach - Dwyer BA, MA, A.Diop. i gCumarsáid Fheidhmeach - Carmel Ní Bhriain BA, MA, Diop. sa Ghaeilge - Fionn Ó Sealbhaigh BA, MA - Norita Ní Chartúir BA Requirements and Assessment Key Facts Entry Requirements Bunchéim Dara hOnóracha, Grád 2 ag leibhéal 8, nó Dara hOnóracha, Grád 2 i gclár iarchéime. Is féidir le hiarrthóirí nach bhfuil na cáilíochtaí acadúla cuí acu, ach a bhfuil ar a laghad cúig bliana de thaithí ghairmiúil acu i réimse na meán nó i réimse gaolmhar, iarratas a dhéanamh faoi chóras na hOllscoile d’Aitheantas don Réamhfhoghlaim (RPL). Is gá d’iarrthóirí Stiúrthóir Acadúil an chláir a shásamh go bhfuil an caighdeán seo acu sa Ghaeilge. Additional Requirements Duration 1MGM1 (lánaimseartha): 1 Bliain | 1MGM2 (páirtaimseartha): 2 Bhliain. Next start date Meán Fómhair 2019 A Level Grades () Average intake Closing Date Moltar iarratas a dhéanamh go luath ag súil le tairiscint luath. Tuilleadh eolais anseo. NFQ level Mode of study ECTS weighting Award CAO Course code 1MGM1 (lánaimseartha) | 1MGM2 (páirtaimseartha) Course Outline Sa chéad seimeastar den chlár lánaimseartha déanfaidh tú staidéar (ar champais na hOllscoile agus in aonaid réigiúnacha RTÉ) ar na modúil seo a leanas: - Cruinnscríobh na Gaeilge 1 (10 ECTS); - Gnéithe den Chraoltóireacht Chomhaimseartha (10 ECTS); - Iriseoireacht na Linne Seo (5 ECTS); - Modheolaíochtaí Tionscadail agus Taighde (5 ECTS). Sa dara seimeastar déanfaidh tú staidéar (agus tú lonnaithe i mBaile Átha Cliath) ar na modúil seo a leanas: - Cruinnscríobh na Gaeilge 2 (10 ECTS); - Cruthú Ábhair ar Ardáin Ilmheán (10 ECTS); - Na Meáin agus a Luchtanna Féachana (5 ECTS); - Eiticí agus Litearthacht na Meán (5 ECTS). Sa triú seimeastar cuirfidh tú Tionscadal Taighde Féinstiúrtha i gcrích (30 ECTS). Cuirfear an clár léinn ar fáil tríd an bhfoghlaim chumaisc, is é sin, beidh béim mhór ar an bhfoghlaim chianda ar líne ach beidh cuid den teagasc ar siúl le linn léachtaí agus ceardlanna ócáideacha ar champais na hOllscoile san iarthar, agus ar an láthair oibre in aonaid Ghaeilge éagsúla de chuid RTÉ. Tabhair faoi deara go mbeidh tú lonnaithe san iarthar sa chéad seimeastar agus i mBaile Átha Cliath sa dara seimeastar. Bainfidh an fhoghlaim ar an láthair oibre in RTÉ go dlúth leis an staidéar acadúil i modúil éagsúla. Más ag leanacht an chláir go páirtaimseartha tú, déanfaidh tú staidéar ar na modúil chéanna ach in imeacht dhá bhliain (15 ECTS in aghaidh an tseimeastair). Cuirfear leagan amach an chláir pháirtaimseartha ar fáil ach é a iarradh. Déanfar measúnóireacht ar an gclár múinte go príomha tríd an measúnóireacht leanúnach. Déanfar measúnóireacht ar an Tionscadal Taighde Féinstiúrtha ag deireadh an chláir. Struchtúr an Chláir Lánaimseartha in imeacht aon bhliain amháin: Páirtaimseartha in imeacht dhá bhliain:[an error occurred while processing this directive] Why Choose This Course? Career Opportunities Who’s Suited to This Course Learning Outcomes Work Placement Study Abroad Related Student Organisations Course Fees Fees: EU Fees: Tuition Fees: Student levy Fees: Non EU Find out More Comhordaitheoir MA (Cleachtas Gairmiúil sna Meáin) R: aodh.ocoileain@oegaillimh.ie