Masters In Medical Technology Regulatory Affairs
Masters inMedical TechnologyRegulatory Affairsirishmedtechskillnet.ie
IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSABOUT IRISH MEDTECH SKILLNETThe Irish Medtech Skillnetand contracting organisation,the Irish Medtech Association,the Ibec group that representsthe Medical Technology sectorand IT Sligo in collaborationwith NUI Galway are delightedto present the new Masters inMedical TechnologyRegulatory Affairs.Working in partnership with Skillnet Ireland and ourcontracting organisation, the Irish Medtech Association (Ibecsector), the Irish Medtech Skillnet has over the past numberof years grown substantially in direct response to the trainingneeds of Industry. Total expenditure (2008 - 2017) is over 6.3 million with 42% contribution from member companiesand the remaining 58% funded by the state. Targets of over8,900 trainees and 46,000 training days have been achieved.ABOUT IRISH MEDTECH ASSOCIATIONThe Irish Medtech Association is a business sector within Ibecthat represents the Medical Technology sector and is aproactive membership organisation with over 170 memberslocated throughout Ireland. It works directly with governmentand policy makers nationally and internationally, to shapebusiness conditions and drive economic growth. Led by aboard of 15 industry leaders, and facilitated by a dedicatedprofessional executive staff, our working groups, forums andtask forces are the primary enablers of our strategy.ENTRY REQUIREMENTSThis programme has been designed to meet the growingrequirements of companies in filling regulatory and qualityassurance roles. The impetus for the development of thisspecialist programme emerged from industry needs and thecontent has been developed in conjunction with a taskforcecomprised of regulatory experts from Irish MedtechAssociation’s Regulatory and Quality Working Group.The course will enable Regulatory Affairs personnel in theMedical Technology industry to understand all currentdevice and diagnostic regulations and to develop the skillsnecessary to address and prepare for the ever-changingglobal environment of regulatory affairs. This is aninternational programme available to students from allregions and provides a unique opportunity to study globalregulatory affairs. It provides access to online lecturesproduced exclusively for the programme by internationalexperts.Upon successful completion of the programme, participantsreceive an MSc award at NFQ Level 9.In collaboration with:Open to students who have obtained a Level 8 primary degreein a science/engineering subject related to the life sciences.Previous or current experience in regulatory affairs (minimumtwo years) may be taken into account in assessing entryqualifications for candidates with relevant Level 7 qualificationwith appropriate experience.Candidates who have completed modules in cognateprogramme areas may also enter the programme and gainexemptions as determined by the Programme Committee inaccordance with the partner Institutions’ guidelines. Caseswill be assessed on an individual basis by the ProgrammeCommittee. Students applying on the basis of formalqualifications and supplementary accredited prior learning(APL) for core pre-requisites will be required to submit fulldetails and references to the Programme Board forconsideration of educational equivalencies. Prior experientiallearning will be assessed using guidelines recommended bythe Academic Council of IT Sligo and NUI Galway.
1IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSassessment dates/times will be communicated to studentsat the start of each new semester. These lectures will be supplemented with additional reading material. Studentswill engage up to 5 hours independent learning per moduleper week.CERTIFICATIONNFQ Level 9 – 90 creditsPROGRAMME COSTSIrish Medtech Skillnet membersresiding and working in Ireland 8,100Non Members residing and working in Ireland 10,800Eligible EU-nationals residing and working inEurope (outside of Ireland) within the last 3 years 12,000Parent company staff of Irish MedtechAssociation member companies, outsideof Ireland, NON-EU nationals 18,000NON Irish Medtech Association membercompanies, outside of Ireland, NON-EU nationals 20,000This includes assessment times and assignments.The workload may vary slightly from week to week.Assessment of students will be based on 100% continuousassessment with assignments throughout the course inconjunction with submission of the final dissertation at theend of year 2.ASSESSMENT GRADING SYSTEMSDELIVERYThe programme will employ a blended learning approachinvolving synchronous and asynchronous online lectures.Lectures are delivered “Live” on a weekly basis to studentsusing the software package Adobe Connect. Studentswho cannot attend the live lectures may view the recordedlectures anytime, with links to the recordings placed on theMoodle page for the respective subject. Lecture recordingscan also be downloaded by students using Panopto software.Moodle acts as the virtual learning environment (VLE)whereby students enrol on a VLE page for a respective subjectand lecturers provide learning materials, notes and handoutsto them via the VLE.The VLE can also be used to assess students throughopen-book exams using multiple choices, matching questionsas well as short and long answer questions. The blendeddelivery format proposed for this programme includes online(synchronous and asynchronous learning), and E-moderateddiscussion boards, as well as workshops, group project work,case studies and variety of other teaching and learning tools.All assessments are assigned a percentage of the totalmodule marks and this is indicated to the students at thecommencement of each module or module part. Thesepercentages are also indicated in the assessment matrices.This is to ensure that the students can assign the appropriatelevel of commitment and energy to any given assessment.SAMPLE DELIVERY SCHEDULEYear 1 - Semester 1(September - December)Week 2 September1 day on campus student inductionMid-Late November1.5 days on campus workshop covering all 3 modules persemesterYear 1- Semester 2Semester 2(January - May)Mid - Late March1.5 days on campus workshop covering all 3 modules persemesterPROGRAMME TEAMPROPOSED STUDENT ENGAGEMENTThe educational elements will be provided by academic stafffrom the Institute of Technology Sligo and NUI Galway.Students will study 3 modules per semester. The studentswill typically have a 1 hour live lecture per week on each ofthe three modules. These lecture slots and associatedAdditional lecturing and workshop contributions, as required,will be provided by industry experts from the MedicalTechnology sector.The programme will be delivered over 2 years.YEAR 1 SEMESTER 1EU Medical Technology Regulatory Affairs - IntroductionUS Medical Technology Regulatory Affairs- IntroductionTechnical Report WritingYEAR 2 SEMESTER 1EU Medical Technology Regulatory Affairs - AdvancedUS Medical Technology Regulatory Affairs - AdvancedRisk Management, Labelling & PromotionYEAR 1 SEMESTER 2Global Medical Technology Regulatory Affairs - IntroductionClinical EvaluationQuality Management SystemYEAR 2 SEMESTER 2Global Medical Technology Regulatory Affairs - AdvancedDesign Assurance, Sterilisation and BiocompatabilityPost Market Surveillance
2IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 1 SEMESTER 1MODULE CONTENTMODULE CONTENTIntroduction to EU Medical TechnologyRegulatory AffairsIntroduction to US Medical TechnologyRegulatory AffairsMODULE DESCRIPTIONMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on the marketin the EU. It explains the legislation applicable and guidelinesavailable to medical device manufacturers.This module is taken by Level 9 students in Medical TechnologyRegulatory Affairs. It aims to provide students with a detailedknowledge and understanding of the regulatory pathway forplacing medical devices on the market in the US. It explainsthe legislation applicable and guidelines available to medicaldevice manufacturers.LEARNING OUTCOMESLEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:On completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of the main EU directives and theircontext within the EU legislative framework includingDirective 98/79/EC2. Source and interpret medical device directives currentlyregulating medical device classification within the EU anddemonstrate ability to classify devices, including complexcombination or novel devices appropriately3. Demonstrate they have detailed knowledge andunderstanding of the role and expectations of themanufacturer, authorized representative, Notified Bodyand Competent Authority4. Demonstrate they have detailed knowledge andunderstanding of current conformity assessmentprocedures5. Source and interpret ISO13485 and various other relevantstandards and guidance documents e.g. MEDDEVS, NBMEDS, GHTF guidance6. Demonstrate they have detailed knowledge andunderstanding of the essential requirements of eachdevice and how a manufacturer will address and meeteach essential requirement7. Identify the submission types involved in the EUregulatory system1. Demonstrate they have detailed knowledge andunderstanding of the US FDA administrative and legislativestructure (FD&C Act) and requirements2. Source and interpret regulations and guidance documentscurrently applicable to medical device classification withinthe US and demonstrate ability to classify devicesappropriately3. Critique FDA guidance documents, consensus standards,FDA forms etc.4. Illustrate an understanding of the steps required toachieve market clearance/approval for a US destinedmedical device including all aspects and types of 510(k),PMA, IDE and De Novo applications.5. Analyze requirements for device registration, device listingand establishment registration and post marketsurveillance requirements once a product is placed on themarket.
3IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 1 SEMESTER 2MODULE CONTENTMODULE CONTENTTechnical Report WritingIntroduction to Global MedicalTechnology Regulatory AffairsMODULE DESCRIPTIONMODULE DESCRIPTIONTechnical Report Writing teaches the participant not onlythe critical techniques a scientist needs to know whenconducting research but also how to write about his orher work. Not only is this relevant for a dissertation and assignments but also for generating formal reports suchas clinical evaluation reports.This module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide students witha detailed knowledge and understanding of the regulatorypathway for placing medical devices on the market outside ofthe US and EU, specifically Russia/CiS; Brazil/Latin America;Canada/Australia. It explains the legislation applicable andguidelines available to medical device manufacturers. It alsoaddresses emerging technologies.Professionals in industry require the skills to sharetheir work with others, to communicate their learning, theirdiscoveries and their failures, thus improving research andthus benefiting the industry as a whole and more importantly,the patient.LEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Appreciate the nature and importance of technical reportwriting and review in industry2. Evaluate the suitability of research methodologies for thepurpose of undertaking research3. Conduct and synthesise an academic literature searchrelevant to a proposed dissertation or topic4. Present the research findings in a critically reflectivemanner which acknowledges the limitations of theresearch methods5. Critically review the ethical issues involved in theundertaking of clinical research6. Formulate and compare methods for data analysis andthe presentation of results and compare differentmethods when presenting different results7. Present a comprehensive dissertation proposalLEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of the administrative and legislativestructure and requirements for medical devices in keyglobal markets to include Russia/CIS; Brazil/LatinAmerica; Canada/Australia2. Identify key differences between these regulatory systemsand that of the EU and US and outline methodology toensure a device can utilize key documentation from EUand US applications in achieving market approval in theabove defined jurisdictions3. Critique guidance, directives and legislation currentlyregulating medical device classification within these globalmarkets and demonstrate ability to classify devicesappropriately4. Articulate an understanding of how to define theregulatory pathway for medical devices in these globalmarkets including complex combination or novel devices5. Demonstrate they have detailed knowledge andunderstanding of how to manage change control from aglobal point of view.6. Source and interpret reimbursement requirements
4IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 1 SEMESTER 2MODULE CONTENTMODULE CONTENTClinical EvaluationQuality Management SystemMODULE DESCRIPTIONMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on themarket in the EU. It explains the legislation applicable andguidelines available to medical device manufacturers.This module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on themarket in the US. It explains the legislation applicable andguidelines available to medical device manufacturers.LEARNING OUTCOMESLEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:On completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of the key clinical terms, types of studies,key clinical requirements and associated standards2. Source and interpret, regulations, standards andguidances on how clinical requirements in chosenmarkets are achieved3. Critique the role of human factors studies and the impactof risk assessment4. Demonstrate an ability to prepare documentationassociated with clinical evaluations5. Demonstrate they have detailed knowledge andunderstanding of clinical investigations applicationprocess and reimbursement6. Illustrate an ability to prepare regulatory submissionsand clinical trial applications7. Formulate and communicate a competency in how tocomplete a full clinical evaluation plan, which will includeobjectives, methodology and literature searchingprocesses and resulting clinical evaluation reportincluding format, contents and layout8. Demonstrate an ability to prepare a clinical evaluationreport9. Identify the interaction between risk analysis and clinicalevaluation10. Evaluate and assess a medical device to determine what,if any, clinical studies are required based upon a criticalreview of existing data for comparable medical devices(consider strategy development, investigation design andclinical evaluation context)1. Demonstrate they have detailed knowledge andunderstanding of how a medical device is designed,developed and manufactured in line with 20 CFR 820and ISO134852. Source and interpret ISO13485, CFR 820 and variousother relevant standards3. Understand and evaluate the key elements of 21 CFR820 including but not exclusive to Quality ManagementSystem, Management responsibility, ResourceManagement, Product Realization, MeasurementAnalysis and Improvement4. Demonstrate they have detailed knowledge andunderstanding of a QMS as specified by CFR8205. Illustrate a thorough understanding of the underlyingprinciples involved in regulatory compliance, theimportance of auditing, best practice on dealing withauditors, Supplier and vendor approach, auditprogramme, preparation, audit management, dealingwith regulatory agencies , audit response process,internal quality standards communication, effective lineclearance, training, process flow charts, Part 11compliance etc.6. Conduct a systematic and independent examinationof the effectiveness of a quality system or of its partsand demonstrate an awareness of the importance ofauditor training and the internal auditing programmeand how to deal with unannounced audits7. Formulate and communicate an ability to implementquality and technical agreements8. Demonstrate they have a detailed knowledge andunderstanding of the required actions to release productpost regulatory approval9. Demonstrate they have detailed knowledge andunderstanding of the regulatory role and requirementsthroughout the product development process
5IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 2 SEMESTER 1MODULE CONTENTMODULE CONTENTEU Medical Technology RegulatoryAffairs AdvancedUS Medical Technology RegulatoryAffairs AdvancedMODULE DESCRIPTIONMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on themarket in the EU, the essential requirements of devices andsubmission types & emerging technologies.This module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on themarket in the US, the essential requirements of devices,submission types and change control and emergingtechnologies.LEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of how to manage change control from aEU regulatory perspective throughout the entire medicaldevice lifecycle2. Demonstrate they have detailed knowledge andunderstanding of how to define the regulatory pathwayfor medical devices including complex combination ornovel devices and devise appropriate regulatorystrategies for a number of theoretical devices3. Demonstrate they have detailed knowledge andunderstanding of the submission types involved bycompletion of mock technical documentation fromclassification through to commercialisation4. Demonstrate they have detailed knowledge andunderstanding of CE Mark renewal process andDirective 98/79/EC5. Demonstrate they have detailed knowledge andunderstanding of additional country specificrequirements prior and post placement on market6. Source and interpret reimbursement requirements ineach member stateLEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of the submission types involved bycompletion of mock submission documentation fromclassification through to commercialization2. Formulate and communicate judgements with regard toregulatory decision making process for devices anddemonstrate ability to interact effectively with FDA agents3. Analyse and evaluate data from US FDA MAUDE(Manufacturer and user facility device experience)database4. Demonstrate they have detailed knowledge andunderstanding of how to manage change control fora product destined for US market5. Source and interpret relevant reimbursementrequirements
6IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 2 SEMESTER 1SYLLABUS YEAR 2 SEMESTER 2MODULE CONTENTMODULE CONTENTRisk Management, Labelling &PromotionGlobal Medical Technology RegulatoryAffairs AdvancedMODULE DESCRIPTIONMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of thelabelling, sale and supply regulatory requirements formedical devices. The module also covers the application ofrisk management to medical devices.LEARNING OUTCOMESThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of theregulatory pathway for placing medical devices on themarket outside of the US and EU, specifically China, Japan,SE Asia (Taiwan/Korea etc). It explains the legislationapplicable and guidelines available to medical devicemanufacturers. It also addresses emerging technologies.On completion of this module the learner will/shouldbe able to:LEARNING OUTCOMES1. Demonstrate they have detailed knowledge andunderstanding of the content and application of ISO14971: Medical devices - application of risk managementto medical devices & risk management planning and thekey components of a risk management file.2. Implement a risk management plan including riskanalysis, risk evaluation, implementation of appropriaterisk controls and conduct a risk/benefit analysis.3. Communicate they have a detailed knowledge andunderstanding of the EU/US/Global legislation andregulations associated with medical device labelling andglobal perspectives on UDI, harmonised symbols,structure of IFU, intended use, contraindications, label /IFU review best practice, elabelling.4. Demonstrate they have a detailed knowledge andunderstanding of the legislation and regulationsassociated with medical device advertising and promotionfrom EU/US and Gobal perspective and also countryspecific requirements.5. Communicate a detailed knowledge of context of off labeluse/on label use and particular requirements for websitecontent.6. Evaluate the relevance of social media (twitter, blogs.)and future directions for advertising and promotion.Evaluate the place of physician /customer contact anddirect to consumer advertising in promotion strategy.7. Formulate and communicate judgements from aregulatory standpoint in each step of the riskmanagement process and demonstrate ability to interacteffectively withregulatory agents.On completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of the administrative and legislativestructure and requirements for medical devices in keyglobal markets to include but not limited to China, Japan,SE Asia (Taiwan/Korea etc)2. Identify key differences between these regulatorysystems and that of the EU and US and outlinemethodology to ensure a device can utilize keydocumentation from EU and US applications in achievingmarket approval in the above defined jurisdictions3. Source and interpret guidance, directives and legislationcurrently regulating medical device classificationwithin these global markets and demonstrate ability toclassify devices appropriately4. Source and interpret local global market standards5. Demonstrate they have detailed knowledge andunderstanding of how to define the regulatory pathwayfor medical devices in these global markets includingcomplex combination or novel devices6. Demonstrate they have detailed knowledge andunderstanding of how to achieve market clearance/approval for a medical device destined for a globalmarketplace and how to address post marketsurveillance requirements once a product is placed onthe market7. Demonstrate they have detailed knowledge andunderstanding of the submission types involved bycompletion of mock technical documentation fromclassification through to commercialization8. Formulate and communicate judgements with regard toregulatory issues for devices such as country specificnuances connected with entry/exit from each countryand demonstrate ability to interacteffectively with appropriate authorities9. Demonstrate they have detailed knowledge andunderstanding of how to manage change control from aglobal point of view10. Source and interpret reimbursement requirements
7IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSSYLLABUS YEAR 2 SEMESTER 2MODULE CONTENTMODULE CONTENTDesign Assurance, Sterilisation andBiocompatabilityPost Market SurveillanceMODULE DESCRIPTIONMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. It aims to provide studentswith a detailed knowledge and understanding of the designassurance process, common sterilization techniques formedical devices, associated standards and validation.It aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.This module is taken by Level 9 students in MedicalTechnology Regulatory Affairs and it aims to providestudents with a detailed knowledge and understanding ofpost market requirements for medical devices. Specificallythis module aims to develop the student’s ability to createand implement a comprehensive post market surveillanceplan to collect, evaluate and respond to data on devicesafety and performance after market approval.LEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Demonstrate an ability to develop verifiable designinputs and understand the links to risk managementactivities2. Demonstrate an ability to design a test protocolincluding risk based acceptance criteria, sample sizesand use of appropriate statistical methods3. Develop a test report strategy and demonstrate ability togenerate reports4. Critically assess the use of standard and non standardtest reports5. Demonstrate they have a detailed knowledge andunderstanding of the common sterilization techniquesfor medical devices6. Source and interpret procedures and standardscurrently regulating medical device sterilization andvalidation requirements7. Source and interpret ISO10993 1 for evaluation of thebiocompatibility of medical devices. Apply classificationof the device as outlined in the standard8. Demonstrate an understanding of the commonbiocompatibility testing methods and interpretationof the test results9. Formulate and communicate an understanding of therationale and benefit of product characterization10. Evaluate sterilization methods under various headingsto include packaging, products effects, costs etc11. Formulate and communicate an ability to generatebiocompatibility reports to meet regulatoryrequirementsLEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Demonstrate they have detailed knowledge andunderstanding of global statutory reporting requirementsincluding local interpretation and current expectationswith particular emphasis on EU and US requirements2. Demonstrate they have detailed knowledge andunderstanding of post market surveillance requirementsand development of a post market surveillance plan thatis consistent with the risk associated with the devicebased on its intended use3. Demonstrate they have detailed knowledge andunderstanding of complaint management includingassessment, evaluation and response to post market data4. Demonstrate they have detailed knowledge andunderstanding of risk management principles andrequirements including the role of detailed riskassessment in the evaluation and response to postmarket data5. Demonstrate they have detailed knowledge andunderstanding of requirements for all types of potentialfield actions including field safety corrective actions,advisory notices and recalls. This shall include anunderstanding of the critical components of effectivefield action management6. Understand the links between CER and risk managementand other documentation to proactively incorporate theseinto routine post market surveillance activities7. Analyse and evaluate post market surveillance datawithin a risk management process to achieve a lowerrisk/better product, e.g. data from US FDA MAUDE(Manufacturer and user facility device experience)database8. Formulate and communicate a post marketingsurveillance strategy which meets appropriate regulatoryrequirements
8IRISH MEDTECH SKILLNETMASTERS IN MEDICAL TECHNOLOGYREGULATORY AFFAIRSYEAR 2MODULE CONTENTMedical Technology Regulatory AffairsDissertationMODULE DESCRIPTIONThis module is taken by Level 9 students in MedicalTechnology Regulatory Affairs. This module aims to equipparticipants with the requisite advanced knowledge,understanding and skills to perform medical device relatedresearch using traditional and emerging research designsinformed by a critical awareness of developments at theforefront of legislation and practice in the medical deviceindustry.LEARNING OUTCOMESOn completion of this module the learner will/shouldbe able to:1. Articulate and elaborate an understanding of currentthinking on the nature of medical device industrychallenges and the value of related research in thatcontext2. Articulate and elaborate an awareness of the ethicaldimensions and philosophical consideration relating tothe device industry in a range of context3. Manage a research project combining independent study,support sessions and supervision effectively4. Write a coherent research proposal with an acceptableresearch question or hypothesis5. Conduct a critically focused literature review6. Analyse data according to accepted models of analysis,showing awareness of alternative models of analysis andtheoretical frameworks7. Sustain from the evidence obtained, a reasoned argumentand draw consistent and coherent conclusions from theresearch evidence8. Express the relevance and significance of theoutcomes/ conclusions of the research project9. Reflect self critically on the outcomes/conclusions ofthe enquiry and on the research process itself10. Write a dissertation which meets postgraduatestandards of technical expertise investigating thesubject area or testing the hypothesis outlined in theresearch proposal11. Devel
Previous or current experience in regulatory affairs (minimum two years) may be taken into account in assessing entry . requirements of companies in filling regulatory and quality assurance roles. The impetus for the development of this . MASTERS IN MEDICAL TECHNOLOGY REGULATORY AFFAIRS. CERTIFICATION NFQ Level 9 - 90 credits PROGRAMME COSTS
A formal Regulatory Management System [RMS] can help with: reduction of regulatory burden on citizens and firms improvement of regulatory quality identification of best choice of policy options Comprised of four elements: 1. regulatory quality tools 2. regulatory processes 3. regulatory institutions 4. regulatory policies 16
Page 1 of 9 Rapid Regulatory Courses in HealthStream Getting Started Tip Sheet Please note: Everyone is required to take two compliance trainings titled: Rapid Regulatory Compliance: Non-clinical I Rapid Regulatory Compliance: Non-clinical II Depending on your position at CHA, you may have more courses on your list. One must complete them all.File Size: 1MBPage Count: 9Explore furtherRapid Regulatory Compliance: Clinical II - KnowledgeQ .quizlet.comRapid Regulatory Compliance: Clinical I - An HCCS .quizlet.comRapid Regulatory Compliance: Non-clinical II-KnowledgeQ .quizlet.comThe Provider Compliance Tip fact sheets are now available .www.cms.govRapid Regulatory Compliance - Non-Clinical - Part Istudyres.comRecommended to you b
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Key words: regulation, regulatory quality, regulatory burden, regulatory management system, regulatory impact analysis, regulatory impact statement, cost of doing business . P a g e 792 . competitiveness, erodes public trust in government and encourages corruption in public institutions and public processes [OECD 2010].
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