Programme Specification

Transcription

1 School of Life and Medical Sciences Title of Programme: Regulatory Affairs Programme Code: LMTOPRAM For Collaborative: External Validation The Organisation for Professionals in Regulatory Affairs (TOPRA) Programme Specification This programme specification is relevant to students entering: 01 January 2018 Stefanie Schmeer Associate Dean of School (Academic Quality Assurance): Signature A programme specification is a collection of key information about a programme of study (or course). It identifies the aims and learning outcomes of the programme, lists the modules that make up each stage (or year) of the programme, and the teaching, learning and assessment methods used by teaching staff. It also describes the structure of the programme, its progression requirements and any programme-specific regulations. This information is therefore useful to potential students to help them choose the right programme of study, to current students on the programme, and to staff teaching and administering the programme. Summary of amendments to the programme Date Section Amendment If you have any queries regarding the changes please AQO@herts.ac.uk

2 Programme Specification Master of Science Regulatory Affairs (Medicines)/ Master of Science Regulatory Affairs (Medical )/ This programme specification (PS) is designed for prospective students, enrolled students, academic staff and potential employers. It provides a concise summary of the main features of the programme and the intended learning outcomes that a typical student might reasonably be expected to achieve and demonstrate if he/she takes full advantage of the learning opportunities that are provided. More detailed information on the teaching, learning and assessment methods, learning outcomes and content for each module can be found in Definitive Module Documents (DMDs) and Module Guides. Section 1 Awarding Institution/Body University of Hertfordshire Teaching Institution The Organisation for Professionals in Regulatory Affairs (TOPRA) University/partner campuses Approved Study Centres Programme accredited by N/A Final Award (Qualification) MSc, PgDip, PgCert All Final Award titles (Qualification and Subject) Regulatory Affairs (Medicines); Regulatory Affairs (Medical ); Regulatory Affairs (PgCert only) FHEQ level of award Language of Delivery 7 English A. Programme Rationale TOPRA is the professional body for individuals working at all levels of regulatory affairs. It has been running a collaborative, externally validated, Master of Science Regulatory Affairs with the University of Hertfordshire since TOPRA has run an MSc programme for more than 25 years. TOPRA courses are widely recognised and respected in the healthcare regulatory affairs sector, and TOPRA sets appropriate standards for regulatory professionals. This part-time, flexible programme is designed for regulatory affairs professionals who have already gained first-hand experience of regulatory affairs but wish to increase the breadth or depth of their knowledge. The well-established programme is continually adapted to meet the ever-changing demands of the regulatory healthcare environment. Candidates can choose from a portfolio of available modules to ensure the overall programme is tailored to their own professional practice and provides development opportunities whatever the stage of their career. The programme is unique in that all content is designed, structured and delivered by TOPRA members who are senior professionals from both the industry and relevant regulatory bodies. This ensures that the MSc always covers the most up-to-date and relevant issues facing regulatory affairs professionals in their everyday practice and ensures all graduates have an indepth knowledge and appreciation of various subjects directly relevant to them. The course provides regulatory knowledge as well as the skills required to be a highly effective regulatory professional, such as leadership, strategic thinking, management and negotiating. The MSc Regulatory Affairs programme includes two pathways Regulatory Affairs (Medicines) and Regulatory Affairs (Medical ). The Medicines Pathway has a primary focus on the registration and regulation of medicines and covers regulatory strategy, quality, nonclinical and clinical requirements. It also addresses regulatory strategy for established active substances and the data requirements for abridged

3 applications, cosmetics and herbal products. It provides a module on the registration of biological, biotechnology and advanced therapy products. There is a strong focus on EU requirements, but throughout the course requirements for other markets are considered and there is a module focusing specifically on the US requirements. Data management and digitalisation are important issues in regulatory affairs and this is also covered in the programme. Although the primary focus of this pathway is medicines, up to 30 credits can be drawn from the Medical Pathway, eg there is an introductory module providing an overview of the regulation of medical devices and modules on drug-device combination products and electrical, electronic and software devices. The Medical Pathway has a primary focus on the regulation of medical devices and covers regulatory strategy, design, development, certification and clinical evaluation of devices as well as surveillance and vigilance. The main focus of the course is the EU requirements but a number of other markets are considered, including a module on the US requirements. More specialist topics, such as drug-device combination products, in vitro diagnostic devices, electrical, electronic and software devices and other technologies, are also covered. In addition up to 30 credits can be taken from the Medicines Pathway, for example an overview of the regulation of medicines in the EU; registration of biological, biotechnology and advanced therapy products; data management and digitalisation in regulatory affairs. Students not wishing to commit to the full MSc are able to register for a postgraduate diploma (requires eight modules) or a postgraduate certificate (requires four modules). Students registering for the postgraduate certificate may take any four modules from either the Medicines or Medical Device pathways. B. Educational Aims of the Programme The programme has been devised in accordance with the University's graduate attributes of programmes of study as set out in UPR TL03. Additionally this programme aims to: Prepare regulatory affairs professionals as students to participate in informed debate and discussion regarding regulatory strategy. Enable students to react and respond to changing guidelines and regulatory systems. Construct regulatory strategies and communicate them to colleagues. Critically analyse relevant research literature and data to inform development of the documentation required at various stages of the product approval process. The Medicines pathway aims to: Enable the students to interpret and critically analyse the complex regulatory requirements, legal and ethical obligations required to gain marketing authorisation and maintain medicines on the market. Communicate with, and interpret communications from, regulatory agencies. The Medical pathway aims to: Enable the students to interpret and critically analyse the complex regulatory requirements, legal and ethical obligations to gain certification and marketing authorisation for medical devices. Communicate with, and interpret communications from both notified bodies and competent authorities. C. Intended Learning Outcomes The programme provides opportunities for students to develop and demonstrate knowledge and understanding, skills and other attributes in the following areas. The programme outcomes are referenced the Frameworks for

4 Higher Education Qualifications of UK Degree-Awarding Bodies (2014), and relate to the typical student. Additionally, the SEEC Credit Level Descriptors for Further and Higher Education (2016) have been used as a guiding framework for curriculum design. Knowledge and Understanding: A1- A critical understanding of the diverse regulatory requirements governing the process of development and design for regulated products. A2- Critically evaluate the international dimension to regulatory processes including global and regional regulatory strategies for healthcare product use or testing. For MSc Regulatory Affairs (Medicines) A3- A critical knowledge of legal directives, regulations, harmonized standards and ethical considerations for development, commercialisation, and marketing of medicines. A4- Critically evaluate the technical documentation and data requirements for submission to, and review by, the competent authorities covering the diverse stages of product development. A5- A critical understanding of the Regulatory and business planning strategies of relevance to the development, approval and compliance of regulated products. Teaching/learning methods & strategies Acquisition of knowledge and understanding is through a combination of lectures, small group case studies, guided and self-directed study. Throughout, the learner is encouraged to undertake independent study both to supplement and consolidate what is being taught/learnt and to broaden their individual knowledge and understanding of the subject. Work related experiential learning is utilised through the course journal in order to contextualize learning and relate to current practice where possible. Assessment Knowledge and understanding are assessed through a range of in module assessments, including in class formatively assessed group work and summatively assessed written coursework (including course journals, posters, briefing documents written essays). Feedback on the coursework for one module can be used in following modules which use similar assessments, for instance the course journal features in all modules and although the content is different the structure is the same. A final dissertation is also required for the award of the MSc. Through the critical review of the subject area knowledge and understanding of the various legislation and regulatory requirements can be demonstrated. The conclusions of the research must also demonstrate an understanding of how to apply the theory to practical examples or questions. For MSc Regulatory Affairs (Medical ) A6- A critical knowledge of the legal directives, regulations, harmonized standards and ethical considerations for development, commercialisation, and marketing of medical devices. A7- Critically evaluate the

5 technical documentation and data requirements for review by Notified Bodies and Competent Authorities covering the diverse stages of product development and the design process for medical devices. A8- A critical understanding of the Regulatory, product management and business planning strategies of relevance to the design and conformance of regulated medical devices. Intellectual skills: B1- Critical evaluation, appraisal and use of regulatory and technical documentation and systems. B2- Ability to critically evaluate research or evidence and propose development strategies/pathways in the field of product development. B3- Interpret, synthesise and apply legal and regulatory directives, regulations and standards pertaining to manufacture, non-clinical and clinical evaluation of products. Practical skills: C1- Provision and appropriate reporting of insightful guidance to colleagues on regulatory and legal directives, regulations and standards. C2-Implementation and evaluation of improvements in performance drawing on innovative or best practice. Teaching/learning methods & strategies Intellectual skills are developed through the methods and strategies outlined above. Analytic, evaluative and problem solving skills are further enhanced through practical application in the workplace and through undertaking the Dissertation module. Throughout, the learner is encouraged to develop intellectual skills further by independent study. Teaching/learning methods & strategies Practical skills are developed through the methods and strategies outlined in section A, specifically these practical skills in C2 are further developed through the use of case studies. Assessment Intellectual skills are assessed through the assessment strategy outlined above. There is a particular emphasis on the assessment of these skills in the Dissertation module. Assessment Practical skills are assessed through the written coursework assessments outlined in section A and specifically through the formative in class reports on case studies and group work. Transferable skills: D1- Determination of appropriate methods to Teaching/learning methods & strategies Transferable skills are developed through the methods and Assessment Transferable skills are assessed through the

6 communicate complex issues. D2- Adaptation and application of acquired skills and knowledge to different contexts. D3- Operate as an effective team member or leader as part of interprofessional teams or multi agency teams. D4- Solve intellectual and professional problems using the full range of learning and professional resources available. strategies outlined in A, B and C. Case studies are an essential part of the course and an opportunity to develop these transferable skills. The 2.5 day face to face residential nature of the taught sessions promotes informally interaction between students and staff and provides opportunities for question and answer sessions in which students can discuss their own experiences. methods and strategies outlined in A, B and C above. D. Programme Structures, Features, Levels, Modules, and Credits The programme is offered in part-time mode (1-6 years), and leads to the award of an MSc Regulatory Affairs (Medicines) or PgDip Regulatory Affairs (Medicines); or an MSc Regulatory Affairs (Medical ) or PgDip Regulatory Affairs (Medical ); or a PgCert Regulatory Affairs. Intake is 11 times yearly at the start of any of the scheduled modules and does not follow a traditional semester entry format. Modules run on a three-year cycle with a total of 5 medicines modules, including the Overview of EU regulatory affairs module (7FHH1138) which runs twice a year, and 4 medical devices modules taking place each year including the Principles of Medical Device Regulatory Affairs which will run annually. Professional and Statutory Regulatory Bodies No Accreditation. TOPRA is the professional body for regulatory affairs and is working in collaboration with the University to deliver this programme. Programme Structure The programme structure and progression information below (Table 1a and 1b) is provided for the final awards. The Programme Learning Outcomes detailed above are developed and assessed through the constituent modules. Table 2 identifies where each learning outcome is assessed. Table 1ai Outline Programme Structure MSc Regulatory Affairs (Medicines) Mode of study: Part time Entry point: Prior to the start of any module as specified above MSc Regulatory Affairs (Medicines) Module Code Credit Points Language of Delivery Compulsory Modules Module Title Dissertation 7FHH English ABC BCA CAB % Examination % Coursework % Practical Semesters

7 Module Code Core Modules Module Titles Overview of EU Regulatory Affairs 7FHH English AB, BC Strategic Planning in Regulatory Affairs 7FHH English AB, BC Credit Points Language of Delivery Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Nonclinical Development Regulatory Requirements for a New Active 7FHH English AB, BC Substance: Quality Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Global Clinical Development Regulatory Control of Clinical Operations 7FHH English AB, BC Regulatory Strategy: From Development to the 7FHH English AB, BC Market Place Regulatory Strategy for Established Active 7FHH English AB, BC Substances Data for Abridged Applications and Specialised Products 7FHH English AB, BC Registration of Biological, Biotechnology and Advanced Therapy Products Leadership and Strategic Management in Regulatory Affairs 7FHH1147 7FHH English English AB, BC AB, BC The US Regulatory Environment 7FHH English AB, BC Data Management and Digitalisation in Regulatory Affairs 7FHH English AB, BC Students must pass at least 6 modules from the list above for the MSc Regulatory Affairs (Medicines). % examination % coursework % Practical Semesters Module Code Optional Modules Module Titles Principles of Medical Device Regulatory Affairs 7FHH English AB, BC Design, Development and Certification of Medical 7FHH English AB, BC Clinical Evaluation of Medical 7FHH English AB, BC Post Market Surveillance and Vigilance for Medical 7FHH English AB, BC Regulatory Strategy in the Post Market Phase 7FHH English AB, BC Drug-device Combinations and Other Technologies 7FHH English AB, BC Regulation of In vitro Diagnostic Medical 7FHH English AB, BC Credit Points Language of Delivery Regulation of Electrical, Electronic and Software 7FHH English AB, BC US Regulation of Medical 7FHH English AB, BC % examination % coursework % Practical Semesters

8 Students may take up to two modules from the list above for the MSc Regulatory Affairs (Medicines). The award of an MSc requires 180 credit points passed at level 7 including the Dissertation. Table 1aii Outline Programme Structure PgDip Regulatory Affairs (Medicines) PgDip Regulatory Affairs (Medicines) Core Modules Module Code Credit Points Language of Delivery % examination % coursework % Practical Semesters Overview of EU Regulatory Affairs 7FHH English AB, BC Strategic Planning in Regulatory Affairs 7FHH English AB, BC Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Nonclinical Development Regulatory Requirements for a New Active 7FHH English AB, BC Substance: Quality Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Global Clinical Development Regulatory Control of Clinical Operations 7FHH English AB, BC Regulatory Strategy: From Development to the 7FHH English AB, BC Market Place Regulatory Strategy for Established Active 7FHH English AB, BC Substances Data for Abridged Applications and Specialised Products 7FHH English AB, BC Registration of Biological, Biotechnology and Advanced Therapy Products Leadership and Strategic Management in Regulatory Affairs 7FHH1147 7FHH English English AB, BC AB, BC The US Regulatory Environment 7FHH English AB, BC Data Management and Digitalisation in Regulatory Affairs 7FHH English AB, BC Students must pass at least 6 modules from the list above for the PgDip Regulatory Affairs (Medicines) Module Code Optional Modules Module Titles Principles of Medical Device Regulatory Affairs 7FHH English AB, BC Design, Development and Certification of Medical 7FHH English AB, BC Clinical Evaluation of Medical 7FHH English AB, BC Post Market Surveillance and Vigilance for Medical 7FHH English AB, BC Regulatory Strategy in the Post Market Phase 7FHH English AB, BC Drug-device Combinations and Other Technologies 7FHH English AB, BC Regulation of In vitro Diagnostic Medical 7FHH English AB, BC Credit Points Language of Delivery % examination % coursework % Practical Semesters

9 Regulation of Electrical, Electronic and Software 7FHH English AB, BC US Regulation of Medical 7FHH English AB, BC Students may take up to two modules from the list above for the PgDip Regulatory Affairs (Medicines). The award of a PgDip requires 120 credit points passed at level 7. Table 1aiii Outline Programme Structure MSc Regulatory Affairs (Medical ) MSc Regulatory Affairs (Medical ) Module Code Credit Points Language of Delivery Compulsory Modules Module Title Dissertation 7FHH English ABC BCA CAB % Examination % Coursework % Practical Semesters Core Modules Module Titles Module Code Principles of Medical Device Regulatory Affairs 7FHH English AB, BC Design, Development and Certification of Medical 7FHH English AB, BC Clinical Evaluation of Medical 7FHH English AB, BC Post Market Surveillance and Vigilance for Medical 7FHH English AB, BC Regulatory Strategy in the Post Market Phase 7FHH English AB, BC Drug-device Combinations and Other Technologies 7FHH English AB, BC Regulation of In vitro Diagnostic Medical 7FHH English AB, BC Regulation of Electrical, Electronic and Software 7FHH English AB, BC US Regulation of Medical 7FHH English AB, BC Leadership and Strategic Management in Regulatory Affairs 7FHH English AB, BC Credit Points Language of Delivery Students must pass at least 6 modules from the list above for the MSc Regulatory Affairs (Medical ). % examination % coursework % Practical Semesters

10 Optional Modules Module Titles Module Code Overview of EU Regulatory Affairs 7FHH English AB, BC Strategic Planning in Regulatory Affairs 7FHH English AB, BC Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Nonclinical Development Regulatory Requirements for a New Active 7FHH English AB, BC Substance: Quality Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Global Clinical Development Regulatory Control of Clinical Operations 7FHH English AB, BC Regulatory Strategy: From Development to the 7FHH English AB, BC Market Place Regulatory Strategy for Established Active 7FHH English AB, BC Substances Data for Abridged Applications and Specialised Products 7FHH English AB, BC Registration of Biological, Biotechnology and Advanced Therapy Products 7FHH English AB, BC The US Regulatory Environment 7FHH English AB, BC Data Management and Digitalisation in Regulatory Affairs 7FHH English AB, BC Credit Points Language of Delivery Students may take up to two modules from the list above for the MSc Regulatory Affairs (Medical ). The award of an MSc requires 180 credit points passed at level 7 including the Dissertation. Table 1aiv Outline Programme Structure Pg Dip Regulatory Affairs (Medicines) PgDip Regulatory Affairs (Medical ) % examination % coursework % Practical Semesters Core Modules Module Code Credit Points Language of Delivery % examination % coursework % Practical Semesters Principles of Medical Device Regulatory Affairs 7FHH English AB, BC Design, Development and Certification of Medical 7FHH English AB, BC Clinical Evaluation of Medical 7FHH English AB, BC Post Market Surveillance and Vigilance for Medical 7FHH English AB, BC Regulatory Strategy in the Post Market Phase 7FHH English AB, BC Drug-device Combinations and Other Technologies 7FHH English AB, BC Regulation of In vitro Diagnostic Medical 7FHH English AB, BC Regulation of Electrical, Electronic and Software 7FHH English AB, BC US Regulation of Medical 7FHH English AB, BC Leadership and Strategic Management in Regulatory Affairs 7FHH English AB, BC

11 Students must pass at least 6 modules from the list above for the Pg Dip Regulatory Affairs (Medical ). Module Code Optional Modules Module Titles Overview of EU Regulatory Affairs 7FHH English AB, BC Strategic Planning in Regulatory Affairs 7FHH English AB, BC Credit Points Language of Delivery Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Nonclinical Development Regulatory Requirements for a New Active 7FHH English AB, BC Substance: Quality Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Global Clinical Development Regulatory Control of Clinical Operations 7FHH English AB, BC Regulatory Strategy: From Development to the 7FHH English AB, BC Market Place Regulatory Strategy for Established Active 7FHH English AB, BC Substances Data for Abridged Applications and Specialised Products 7FHH English AB, BC Registration of Biological, Biotechnology and Advanced Therapy Products 7FHH English AB, BC The US Regulatory Environment 7FHH English AB, BC Data Management and Digitalisation in Regulatory Affairs 7FHH English AB, BC % examination % coursework % Practical Semesters Students may take up to two modules from the list above for the MSc Regulatory Affairs (Medical ). The award of a PgDip requires 120 credit points passed at level 7. Table 1av Outline Programme Structure Pg Cert Regulatory Affairs PgCert Regulatory Affairs Module Code Optional Modules Module Titles Overview of EU Regulatory Affairs 7FHH English AB, BC Strategic Planning in Regulatory Affairs 7FHH English AB, BC Credit Points Language of Delivery Regulatory Strategy for a New Active Substance: 7FHH English AB, BC Nonclinical Development Regulatory Requirements for a New Active 7FHH English AB, BC Substance: Quality Regulatory Strategy for a New Active Substance: 7FHH English AB, BC % examination % coursework % Practical Semesters

12 Global Clinical Development Regulatory Control of Clinical Operations 7FHH English AB, BC Regulatory Strategy: From Development to the 7FHH English AB, BC Market Place Regulatory Strategy for Established Active 7FHH English AB, BC Substances Data for Abridged Applications and Specialised Products 7FHH English AB, BC Registration of Biological, Biotechnology and Advanced Therapy Products Leadership and Strategic Management in Regulatory Affairs 7FHH1147 7FHH English English AB, BC AB, BC The US Regulatory Environment 7FHH English AB, BC Data Management and Digitalisation in Regulatory 7FHH English AB, BC Affairs Principles of Medical Device Regulatory Affairs 7FHH English AB, BC Design, Development and Certification of Medical 7FHH English AB, BC Clinical Evaluation of Medical 7FHH English AB, BC Post Market Surveillance and Vigilance for Medical 7FHH English AB, BC Regulatory Strategy in the Post Market Phase 7FHH English AB, BC Drug-device Combinations and Other Technologies 7FHH English AB, BC Regulation of In vitro Diagnostic Medical 7FHH English AB, BC Regulation of Electrical, Electronic and Software 7FHH English AB, BC US Regulation of Medical 7FHH English AB, BC The award of a PgCert requires 60 credit points passed at level 7 from Table 1av above. Table 1b Final and interim awards available The programme provides the following final and interim awards: Final Award Masters Masters Postgraduate Diploma Postgraduate Diploma Award Title MSc Regulatory Affairs (Medicines) MSc Regulatory Affairs (Medical ) PgDip Regulatory Affairs (Medicines) PgDip Regulatory Minimum requirements 180 credit points including at least 150 at level credit points including at least 150 at level credit points, including at least 90 at level credit points, including Available at end of Programme Learning Outcomes developed (normally): (see above) 2-6 years A1, A2, A3, A4, A5, B1, B2, B3, C1, C2, D1, D2, D3, D4 2-6 years A1, A2, A6, A7, A8, B1, B2, B3, C1, C2, D1, D2, D3, D4 2-6 years A1, A2, A3, A4, A5, B1, B2, B3, C1, C2, D1, D2, D3, D4 2-6 years A1, A2, A6, A7, A8, B1, B2, B3, C1, C2, D1, D2, D3, D4

13 Postgraduate Certificate Affairs (Medical ) PgCert Regulatory Affairs at least 90 at level 7 60 credit points, including at least 45 at level Years The knowledge and understanding gained will depend on the topics chosen but at least four of the eight knowledge and understanding learning outcomes will be met. In addition the following learning outcomes will be met B1, B2, B3, C1, C2, D1, D2, D3, D4. Masters and Diploma awards can be made "with Distinction" or "with Commendation" where criteria as described in UPR AS14, Section D and the students' handbook are met. Programme-specific assessment regulations The programme is compliant with the University's academic regulations (in particular, UPR AS11, UPR AS12/UPR AS13 and UPR AS14) with the exception of those listed below, which have been specifically approved by the University: No compensation is permitted between or within modules. The maximum period within which a student may gain an award is 6 years from the date of their first enrolment. With distinction and With commendation awards can be made to students transferring from the University of Wales MSc in Regulatory Affairs until September 2019 provided they are awarded at least 60 credits by the University of Hertfordshire. The calculation of the award will be based on the best 150 credits at level 7, which can include credits awarded at the University of Wales but must include at least 60 credits awarded at the University of Hertfordshire. Further points of clarification and interpretation relevant to this specific programme are given below: Normally full attendance at the residential modules is required; if any student misses up to 5 hours of any residential module due to circumstances beyond their reasonable control the student may be permitted to submit for assessment at the discretion of the Course Director and Link Tutor if it is felt that the student can still meet all required learning outcomes. If any student misses more than 5 hours of any residential module the student may not be permitted to submit for assessment and might be required to repeat the module. E. Management of Programme & Support for student learning Management The programme is managed and administered through: A Head of Professional Development, responsible for all of TOPRA s educational and training courses A part time Course Director, who is responsible for day to day management of the programme A designated full time administrator responsible for overseeing the programme and links closely to the UH and the students Module Leaders A Programme Committee which reports to the School Academic Committee Support Students are supported by:

14 Module coordinators and module teams who are responsible for individual modules External Examiners responsible for the marking of assignments A University of Hertfordshire Link Tutor A Dissertation Supervisor responsible for the supervision and guidance of students undertaking their projects Student representative via a Student Representation Committee A Programme committee, the membership of which includes, Chair: The Course Director, TOPRA Head of Professional Development, Available module leaders, Examiner(s), Postgraduate Administrator, Student representative(s) and UH tutor link. Dedicated and guaranteed (10 hours) access to a Dissertation advisor Guided student centred learning though the use of StudyNet A student centre providing advice on finance, legal issues, University regulations etc New student induction sessions at all modules Student representatives on the programme committee A dedicated student representative committee An extensive Learning resources Centre, incorporating IT facilities and extensive digital collections of medical and healthcare journals Negotiated access to several institution and society libraries and databases through TOPRA Head of Department of Pharmacy, Pharmacology and Postgraduate Medicine Associate Dean Academic Quality Assurance Dean of School of Life and Medical Sciences F. Other sources of information In addition to this Programme Specification, the University publishes guidance to registered students on the programme and its constituent modules: A Programme (or Student) Handbook (Updated annually); A Definitive Module Document (DMD) for each constituent module; A Module Guide for each constituent module. On the university website StudyNet The A-Z of the University of Hertfordshire is an introduction to the academic, social, cultural and sporting services and opportunities available at the University of Hertfordshire, and includes the Student Charter and Student Code of Conduct. As a condition of registration, all students of the University of Hertfordshire are required to comply with the University's rules, regulations and procedures. These are published in a series of documents called University Policies and Regulations (UPRs). The University requires that all students consult these documents which are available on-line, on the UPR web site, at: In particular, UPR SA07 Regulations and Advice for Students Particular Attention - Index provides information on the UPRs that contain the academic regulations of particular relevance for undergraduate and taught postgraduate students. The UK Quality Assurance Agency for Higher Education (QAA) has confirmed the quality and standards of provision at the University of Hertfordshire. A key part of QAA's role is to review and report on how universities maintain their academic standards and quality, to inform students and the wider public. The team of QAA reviewers visited the University of Hertfordshire in 2015/16 and judged that its academic standards, the quality and enhancement of its students learning experience, and the quality of information about this learning experience all meet UK expectations. In other words, the University meets national requirements for standards and quality. The QAA s report can be accessed at: G. Entry requirements Entry requirements for the programme normally specify a Science degree (at the equivalent of a 2.2 or above) and that the student has obtained basic knowledge about regulatory affairs processes, documentation in the

15 healthcare industry and has professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management. Candidates that do not possess the formal academic qualifications but have wide regulatory knowledge and skills may also be accepted if the candidate can demonstrate through submission of a portfolio that they are academically suited to complete the course successfully. This portfolio normally includes: a written piece of work; evidence of regulatory knowledge and skills; any higher education level credits already gained. The portfolio will be judged against the following criteria: The portfolio should: Be coherent and have logical structure Show an ability to reflect critically on the candidate s own experience in an area of regulatory affairs, healthcare product development and lifecycle management Demonstrate knowledge and understanding of the regulation of medical devices or medicines as shown by a track record in an area of regulatory affairs, healthcare product development and lifecycle management Demonstrate ability to apply regulatory guidance and legislation to practical situations Provide adequate and appropriate selection of literature references This portfolio will be judged using a numerical rating scale, the candidate needs to achieve 50 % or above (pass) for all the criteria above to be admitted to the Programme. The candidates will receive further instructions on how to complete the portfolio, along with these grading criteria, upon request. If you think this applies to you, please contact TOPRA or the Course Director for a discussion. Entry to the programme is at the discretion of the TOPRA admissions panel and requires approval by the UH Link Tutor. Students without a degree who are admitted via the portfolio or those with a science degree but no direct work experience in regulatory affairs, but who have experience in a wider area of healthcare product development and lifecycle management would normally be required to take either Overview of Regulatory Affairs or Principles of Medical Device Regulatory Affairs as their first module; as these are introductory courses designed to develop an acceptable level of understanding. Students of the MSc Regulatory Affairs of the University of Wales will still be accepted for transfer to the UH course Regulatory Affairs (Medicines) with an exemption to UH regulations until September Following an Application for the Accreditation of Prior Certificated Learning procedure (APCL), the credits for their modules are transferred to the UH student system, including the marks for the modules and students will still be entitled to honours degrees. Students from the University of Wales who finished the TOPRA Regulatory Affairs course with a Postgraduate Diploma award and are still active regulatory professionals might be given an opportunity to complete a dissertation with an MSc award by admission via an APCL procedure which includes a portfolio. This portfolio normally includes: a written piece of work; evidence of continued exposure to regulatory knowledge and skills after the Postgraduate Diploma was obtained. This portfolio will be judged using a numerical rating scale, the candidate needs to achieve 50 % or above (pass) for all the criteria above to be admitted to the Programme. The candidates will receive further instructions on how to complete the portfolio, along with these grading criteria, upon request. Note that the marks of all credited modules need to be above 50% or the module or equivalent module needs to be retaken. Overseas applicants should normally hold equivalent qualifications to home-based students. An IELTS (International English Language Testing System) certificate 6.5 overall (with no individual component below 6.0) will normally be required for applicants whose first language is not English. The Course Director and the Link Tutor may consider the candidate s proficiency has been proven by their regulatory work output in English and/or through working and living in the UK or in a company that only communicates in English. Accredited Prior Certified Learning (APCL) will normally be granted to applicants who meet the entry requirements stated above and have successfully completed the following TOPRA short courses: - Principles of Medical Regulatory Affairs (to replace module 7FHH1151) - Design, Development and Certification of Medical (to replace module 7FHH1152) - Critical Evaluation of Medical (to replace module 7FHH1153) - Regulation of In Vitro Diagnostic Medical (to replace module 7FHH1157)

16 As the modules may be held in a range of international locations applicants must ensure they hold an appropriate visa to travel to any country where modules are held prior to the commencement of any specific module. The programme is subject to the University's Principles, Policies and Regulations for the Admission of Students to Undergraduate and Taught Postgraduate Programmes (in UPR SA03), along with associated procedures. These will take account of University policy and guidelines for assessing accredited prior certificated learning (APCL). If you would like this information in an alternative format please contact: The UH Link Tutor by m.mullane@herts.ac.uk If you wish to receive a copy of the latest Programme Annual Monitoring and Evaluation Report (AMER) and/or the External Examiner s Report for the programme, please a request to aqo@herts.ac.uk

17 MSc/PgDip Regulatory (Medicines) Table 2a: Development of Intended Programme Learning Outcomes in the Constituent Modules This map identifies where the programme learning outcomes are assessed in the constituent modules. It provides (i) an aid to academic staff in understanding how individual modules contribute to the programme aims (ii) a checklist for quality control purposes and (iii) a means to help students monitor their own learning, personal and professional development as the programme progresses. Programme Learning Outcomes (as identified in section 1 and the following Knowledge & Understanding page) Intellectual Skills Practi cal Skills Transferable Skills Module Title Module Code A1 A2 A3 A4 A5 A6 A7 A8 B1 B2 B3 C1 C2 D1 D2 D3 D4 Dissertation * 7FHH1110 ( ) ( ) Overview of Regulatory Affairs 7FHH1138 Strategic Planning in 7FHH1139 Regulatory Affairs Regulatory Strategy for a 7FHH1140 New Active Substance: Nonclinical Development Regulatory Requirements 7FHH1141 for a New Active Substance: Quality Regulatory Strategy for a 7FHH1142 New Active Substance: Global Clinical Development Regulatory Control of 7FHH1143 Clinical Operations Regulatory Strategy: From 7FHH1144 Development to the Market Place Regulatory Strategy for 7FHH1145 Established Active Substances Data for Abridged 7FHH1146 Applications and Specialised Products Registration of Biological, 7FHH1147 Biotechnology and Advanced Therapy Products Leadership and Strategic 7FHH1148 Management in Regulatory

18 Affairs The US Regulatory Environment Data Management and Digitalisation in Regulatory Affairs Principles of Medical Device Regulatory Affairs Design, Development and Certification of Medical Clinical Evaluation of Medical Post Market Surveillance and Vigilance for Medical Regulatory Strategy in the Post Market Phase Drug-device Combinations and Other Technologies Regulation of In vitro Diagnostic Medical Regulation of Electrical, Electronic and Software US Regulation of Medical 7FHH1149 7FHH1150 7FHH1151 7FHH1152 7FHH1153 7FHH1154 7FHH1155 7FHH1156 7FHH1157 7FHH1158 7FHH1159 *Compulsory Module Core Module Optional Module

19 MSc/PgDip Regulatory Affairs (Medical ) Table 2b: Development of Intended Programme Learning Outcomes in the Constituent Modules This map identifies where the programme learning outcomes are assessed in the constituent modules. It provides (i) an aid to academic staff in understanding how individual modules contribute to the programme aims (ii) a checklist for quality control purposes and (iii) a means to help students monitor their own learning, personal and professional development as the programme progresses. Programme Learning Outcomes (as identified in section 1 and the following Knowledge & Understanding page) Intellectu al Skills Practi cal Skills Transferable Skills Module Title Module Code A1 A2 A3 A4 A5 A6 A7 A8 B1 B2 B3 C1 C2 D1 D2 D3 D4 Dissertation * 7FHH1110 ( ) ( ) Principles of Medical 7FHH1151 Device Regulatory Affairs Design, Development and 7FHH1152 Certification of Medical Clinical Evaluation of 7FHH1153 Medical Post Market Surveillance 7FHH1154 and Vigilance for Medical Regulatory Strategy in the 7FHH1155 Post Market Phase Drug-device Combinations 7FHH1156 and Other Technologies Regulation of In vitro 7FHH1157 Diagnostic Medical Regulation of Electrical, 7FHH1158 Electronic and Software US Regulation of Medical 7FHH1159 Leadership and Strategic 7FHH1148 Management in Regulatory Affairs Overview of Regulatory Affairs 7FHH1138 Strategic Planning in 7FHH1139 Regulatory Affairs Regulatory Strategy for a 7FHH1140

20 New Active Substance: Nonclinical Development Regulatory Requirements for a New Active Substance: Quality Regulatory Strategy for a New Active Substance: Global Clinical Development Regulatory Control of Clinical Operations Regulatory Strategy: From Development to the Market Place Regulatory Strategy for Established Active Substances Data for Abridged Applications and Specialised Products Registration of Biological, Biotechnology and Advanced Therapy Products The US Regulatory Environment Data Management and Digitalisation in Regulatory Affairs 7FHH1141 7FHH1142 7FHH1143 7FHH1144 7FHH1145 7FHH1146 7FHH1147 7FHH1149 7FHH1150 *Compulsory Module Core Module Optional Module () The thesis will either address A1 and A3-5 or A1 and A6-8.

21 PgCert Regulatory Affairs Table 2c: Development of Intended Programme Learning Outcomes in the Constituent Modules This map identifies where the programme learning outcomes are assessed in the constituent modules. It provides (i) an aid to academic staff in understanding how individual modules contribute to the programme aims (ii) a checklist for quality control purposes and (iii) a means to help students monitor their own learning, personal and professional development as the programme progresses. Programme Learning Outcomes (as identified in section 1 and the following page) Knowledge & Understanding Intellectual Skills Practi cal Skills Transferable Skills Module Title Module Code A1 A2 A3 A4 A5 A6 A7 A8 B1 B2 B3 C1 C2 D1 D2 D3 D4 Overview of Regulatory Affairs 7FHH1138 Strategic Planning in 7FHH1139 Regulatory Affairs Regulatory Strategy for a 7FHH1140 New Active Substance: Nonclinical Development Regulatory Requirements 7FHH1141 for a New Active Substance: Quality Regulatory Strategy for a 7FHH1142 New Active Substance: Global Clinical Development Regulatory Control of 7FHH1143 Clinical Operations Regulatory Strategy: From 7FHH1144 Development to the Market Place Regulatory Strategy for 7FHH1145 Established Active Substances Data for Abridged 7FHH1146 Applications and Specialised Products Registration of Biological, 7FHH1147 Biotechnology and Advanced Therapy Products Leadership and Strategic 7FHH1148 Management in Regulatory Affairs

22 The US Regulatory Environment Data Management and Digitalisation in Regulatory Affairs Principles of Medical Device Regulatory Affairs Design, Development and Certification of Medical Clinical Evaluation of Medical Post Market Surveillance and Vigilance for Medical Regulatory Strategy in the Post Market Phase Drug-device Combinations and Other Technologies Regulation of In vitro Diagnostic Medical Regulation of Electrical, Electronic and Software US Regulation of Medical 7FHH1149 7FHH1150 7FHH1151 7FHH1152 7FHH1153 7FHH1154 7FHH1155 7FHH1156 7FHH1157 7FHH1158 7FHH1159

23 KEY TO PROGRAMME LEARNING OUTCOMES Knowledge and Understanding A1. A critical understanding of the diverse regulatory requirements governing the process of development and design for regulated products. A2. Critically evaluate the international dimension to regulatory processes including global and regional regulatory strategies for healthcare product use or testing. A3. A critical knowledge of legal directives, regulations, harmonized standards and ethical considerations for development, commercialisation, and marketing of medicines. A4. Critically evaluate the technical documentation and data requirements for submission to, and review by, the competent authorities covering the diverse stages of product development. A5. A critical understanding of the Regulatory and business planning strategies of relevance to the development, approval and compliance of regulated products. A6. A critical knowledge of the legal directives, regulations, harmonized standards and ethical considerations for development, commercialisation, and marketing of medical devices. A7. Critically evaluate the technical documentation and data requirements for review by Notified Bodies and Competent Authorities covering the diverse stages of product development and the design process for medical devices. A8. A critical understanding of the Regulatory, product management and business planning strategies of relevance to the design and conformance of regulated medical devices. Practical Skills C1. Provision and appropriate reporting of insightful guidance to colleagues on regulatory and legal directives, regulations and standards. C2. Implementation and evaluation of improvements in performance drawing on innovative or best practice. Intellectual Skills B1. Critical evaluation, appraisal and use of regulatory and technical documentation and systems. B2. Ability to critically evaluate research or evidence and propose development strategies/pathways in the field of product development. B3. Interpret, synthesise and apply legal and regulatory directives, regulations and standards pertaining to manufacture, non-clinical and clinical evaluation of products. Transferable Skills D1. Determination of appropriate methods to communicate complex issues. D2. Adaptation and application of acquired skills and knowledge to different contexts. D3. Operate as an effective team member or leader as part of inter-professional teams or multi agency teams. D4. Solve intellectual and professional problems using the full range of learning and professional resources available.

24 Section 2 Programme management Relevant QAA subject benchmarking statements Type of programme Postgraduate Date of validation/last periodic review January 17 Date of production/ last revision of PS 30/06/2016 Relevant to level/cohort Level 7 entering January 2018 Administrative School School of Life and Medical Sciences Table 3 Course structure Course details Course code Course description JACS LMTARAMMSC LMTARAMPGD LMTARAMPGC LMTARAMDMSC LMTARAMDPGD MSc Regulatory Affairs (Medicines) PgDip Regulatory Affairs (Medicines) PgCert Regulatory Affairs MSc Regulatory Affairs (Medical ) PgDip Regulatory Affairs (Medical ) B290 (Medicines) / (Regulatory Affairs) B895 (Medical ) Course Instances Instances code Intake Stream Instances Year RAM1FEB1DP A,B,C MSc/PgD Regulatory Affairs (Medicines): PgC Regulatory Affairs: RAM1APR1DP A,B,C RAM2APR1DP A,B,C RAMD1FEB1D P RAMD1APR1D P RAMD2APR1D P A,B,C A,B,C A,B,C MSc/PgD Regulatory Affairs (Medicines): PgC Regulatory Affairs: MSc/PgD Regulatory Affairs (Medicines): PgC Regulatory Affairs: MSc/PgD Regulatory Affairs (Medical ): PgC Regulatory Affairs: MSc/PgD Regulatory Affairs (Medical ): PgC Regulatory Affairs: MSc/PgD Regulatory Affairs (Medical ): PgC Regulatory Affairs: Location: 1 TOPRA VENUES (UK, EUROPE, OVERSEAS) 1 TOPRA VENUES (UK, EUROPE, OVERSEAS) 2 TOPRA VENUES (UK, EUROPE, OVERSEAS) 1 TOPRA VENUES (UK, EUROPE, OVERSEAS) 1 TOPRA VENUES (UK, EUROPE, OVERSEAS) 2 TOPRA VENUES (UK, EUROPE, OVERSEAS) Mode of study Part-time Part-time Part-time Part-time Part-time Part-time Masters Programme Specification / December 2016 /