TOPRA MSc prospectus 2013

E n a b l i n g a n d p r o m o t i n g E x c E l l E n c E i n t h E h E a l t h c a r E r E g u l a t o r y p r o f E s s i o n

Prospectus

MSc in Regulatory AffairsV a l i d a t E d b y t h E u n i V E r s i t y o f h E r t f o r d s h i r E

introductionThe MSc in Regulatory Affairs offered by TOPRA and now validated by the University of Hertfordshire, provides a unique opportunity to study aspects of regulatory affairs at an advanced level.

the course was established in 1989, and is designed for professionals working in regulatory affairs who have already gained first-hand experience of handling regulatory issues. such experience may be in one area of regulatory affairs that could be developed and broadened by studying for the msc. alternatively, your experience may cover a wide regulatory area but would benefit from the in-depth considerations of the topics covered in the course.

studying for the msc can therefore benefit the person at a relatively early stage in their career in regulatory affairs, or the more experienced person who has perhaps worked in their industrial functions before specialising in regulatory affairs.

stand-alone modules can also be studied for continuing professional development (cpd). topra takes full responsibility for the operation and management of the course, which is fully validated and approved by the university of hertfordshire.

TOPRA has used over 25 years’ experience of providing training courses to produce a structured, continuing development programme of courses, meetings and seminars to meet the needs of regulatory professionals at all stages in their careers.

the msc qualification is awarded by the university of hertfordshire.this degree is validated and awarded by the university of hertfordshire, uK.for further details regarding the university and its validation services, please log on to http://www.herts.ac.uk

regulations for the scheme of study leading to the msc in regulatory affairs

This part-time course is designed to meet the postgraduate educational and vocational needs of personnel employed in the field of Regulatory Affairs in the pharmaceutical and allied industries.

Five two and a half day modules are held per academic year, with module 7FHH1097 taking 4.5 days. Thirteen modules and a dissertation module of relevance to the pharmaceutical industry have been established.

An outline of the syllabus for each module is provided in this brochure. The MSc is organised and operated by TOPRA – The Organisation for Professionals in Regulatory Affairs. It is validated by the University of Hertfordshire and the qualifications are awarded by the University of Hertfordshire.

To obtain the MSc a student, who may enrol at any module, must take eight modules over a maximum period of five years and satisfy the other requirements stated in the schedule of assessment, including the completion of a research-based dissertation.

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Entry requirementsto be admitted to the msc, candidates will normally have 2 years’ experience in regulatory affairs and hold a science degree (or cognate discipline), or the equivalent in the opinion of the admissions panel.

candidates whose first language is not English must also demonstrate knowledge of written and spoken English sufficient to enable them to undertake the course.

an iElts (6.5) toEfl (580) or igcE will be accepted. topra makes no distinctions in its admissions policy with regard to disability. topra will make every reasonable effort to supply students with services that meet their needs.

course structurethe msc course consists of a series of free-standing modules. five modules are offered each year. the aim is to provide flexibility and choice for students, but students cannot attend more than four modules per year. students studying for the msc are required to attend eight modules within a minimum of two and maximum of five years. students are required to satisfy the examiners in eight modules by completion of coursework assignments for each module. students must then submit an msc dissertation of 18,000 – 20,000 words. dissertations must not exceed the stated word limits. for those not wishing to complete the full msc, exit awards are available – a pg.cert. (postgraduate certificate) for successfully completing 4 modules and a pg.dip. (postgraduate diploma) for successfully completing 8 modules. only one award can be claimed for any single period of on-going study.

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modules

structure of the individual modulesEach module (except the introductory course) lasts two and a half days and is structured around lectures, case studies and discussion groups conducted in English. lecturers are drawn from the industry, regulatory authorities and academia.in most modules emphasis is given to discussion of European regulatory requirements and to practical problems involved in meeting them. Where appropriate, comparisons are made with the regulatory requirements of other major markets.

Thirteen Modules Relating to the Pharmaceutical Industry are Offered:

• 7FHH1097 – overview of Eu regulatory affairs 8

• 7FHH1098 – strategic planning in regulatory affairs 9

• 7FHH1099 – regulatory strategy for a new active substance: preclinical development 10

• 7FHH1100 – regulatory requirements for a new chemical active substance: 11 chemistry and pharmacy

• �7FHH1101 – regulatory strategy for a new active substance: 12 global clinical development

• 7FHH1102 – regulatory control of clinical operations 13

• 7FHH1103 – regulatory strategy: the market place 14

• 7FHH1104 – regulatory strategy for Established active substances 15

• 7FHH1105 – data requirements for abridged applications and specialised products 16

• 7FHH1106 – registration of biological, biotechnology and advanced therapy products 17

• 7FHH1107 – optimising the contribution of regulatory affairs to product development, 18 maintenance and commercialisation

• 7FHH1108 – the us regulatory Environment 19

• 7FHH1109 – medical device regulatory affairs 20

• 7FHH1110 – dissertation 21

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module schedule

the schedule for the modules over the next seven academic years is detailed below.

Sept/Oct Nov/Dec Jan/Feb Mar/Apr May/June

2012/2013 7fhh1099 7fhh1100 &7fhh1097 7fhh1101 7fhh1102 &7fhh1097 7fhh1103








specific dates for the current academic year are published on the topra website and in the module booking form.the syllabuses for the modules are described later. a degree of flexibility both in the specific content of individual modules and the number of modules offered is maintained in order that they can be updated to keep abreast of regulatory requirements and to meet the changing needs of the regulatory professional.

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modules

Work to be undertaken

Modulefollowing each module the student must complete coursework assignments related to the module topic. the course work is assessed at defined time points during the academic year in which the modules are undertaken. submission dates for the course journals and assignments are given at each individual module.

a maximum period of four months is allowed for completion of course work.

MSc Dissertationfollowing successful completion of 8 modules, students may submit a research based msc dissertation of 18,000 – 20,000 words. this must be completed within five years of first registration for the course.

students are required to satisfy the examiners with respect to the coursework prepared for each module undertaken. they must also satisfy the examiners with respect to the msc dissertation. should a candidate fail to satisfy the board of Examiners, course work may be resubmitted within a time-frame stipulated by the board of Examiners.

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modules

summary of syllabuses for Each modulethe msc course is designed for regulatory affairs professionals working in the pharmaceutical industry. to operate successfully, regulatory affairs professionals require a thorough understanding of regulatory affairs in all its aspects and the ability to apply the knowledge in a strategic way.

the programme of individual modules was developed to provide the wide knowledge base necessary to fulfil the regulatory affairs function. the syllabus encompasses major aspects of pharmaceutical legislation, scientific principles and commercial practice underpinning the role of regulatory affairs.

module 7fhh1098 represents a platform for understanding pharmaceutical legislation and industry issues necessary for optimising the contribution of the regulatory function to development of strategic product management in both large and small companies. modules 7fhh1099, 37fhh1100 and 7fhh1101 concentrate on critical evaluation of scientific issues and implications for drug development in the three areas of data required for product registration, ie. chemistry and pharmacy, preclinical and clinical.

appreciation of the regulatory, legal and practical obligations in conducting clinical research and successful marketing are considered in modules 7fhh1102 and 7fhh1103 respectively.

critical issues for registration of new dosage forms containing established active substances and other abridged registration applications are assessed from a procedural perspective in module 7fhh1104 and from the perspective of data requirements in module 7fhh1105.

in addition to the basic programme provided by modules 7fhh1098 to 7fhh1105, modules on more specialised topics are included. currently these cover the following topics:

• specific product types of major regulatory importance such as biological and biotechnological products, advanced therapy products, and medical devices (modules 7fhh1106 and 7fhh1109)

• special features of operating in the major pharmaceutical market of the usa (module 7fhh1108)

• optimising the management function of regulatory affairs to fulfil its crucial role in drug development throughout the product lifecycle (module 7fhh1107).

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Module 7FHH1097overview of Eu regulatory affairs

module aims:

The aims of this module are to enable students to...

• consider and understand regulatory aspects of regulatory affairs in the Eu

• Explore and appreciate the regulatory issues likely to arise during drug development in order to be able to provide effective advice on the regulatory affairs activities involved with drug development.

learning outcomes

Knowledge and Understanding:Successful students will typically:

• possess a systematic understanding of knowledge, and a critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the Eu and regulatory marketing authorisation in the context drug development

• demonstrate a conceptual understanding of the regulatory requirements Eu directives and legislation regulatory authorisation and associated documentation for marketing submissions to evaluate critically current developments

• display a comprehensive understanding of the Eu regulatory aspects of drug development.

Skills and Attributes:Successful students will typically:

• demonstrate the ability to critically analyse the legal documentation and guideline considerations of Eu regulatory affairs

• Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences in relation to obtaining regulatory authorisation

• critically appraise and evaluate communications from regulatory bodies and research publications.

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Module 7FHH1098 strategic planning in regulatory affairs

module aims:


• consider and appreciate strategic regulatory aspects of global regulatory affairs

• Explore and review the strategic regulatory issues in order to be able to provide effective advice on the commercial implications of regulatory affairs activities involved with approval and pricing negotiations.

learning outcomes


• demonstrate a systematic understanding of knowledge, and a critical awareness of the theory and practice of global strategic planning strategies as they relate to obtaining regulatory marketing authorisation and pricing negotiations

• display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes

• demonstrate an in depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes.


• critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development

• demonstrate the ability to critically analyse the legal documentation and regulatory considerations of drug development

• Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.

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Module 7FHH1099 regulatory strategy for a new active substance: preclinical development

module aims:


• consider and understand preclinical regulatory aspects for global drug development

• Explore and review the regulatory issues likely to arise during preclinical programmes in order to be able to provide effective advice on such situations.

learning outcomes


• develop a systematic understanding of knowledge, and a critical awareness of the practical aspects of preclinical development, types and design of preclinical safety studies and pharmacokinetic requirements in the context of the preclinical research phase of drug development

• demonstrate a comprehensive understanding of the preclinical regulatory requirements, preclinical guidelines and other requirements for running preclinical drug safety studies

• have a conceptual understanding of the legal and ethical aspects of preclinical research and importation of medicinal products to evaluate critically current research.


• demonstrate the ability to critically analyse the preclinical regulatory documentation and guidelines for the preclinical part of drug development

• Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences

• critically appraise and evaluate communications from regulatory bodies and research publications covering the preclinical data.

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Module 7FHH1099 regulatory strategy for a new active substance: preclinical development

Module 7FHH1100 regulatory requirements for a new active substance: chemistry and pharmacy

module aims:


• Explore and understand the regulatory issues likely to arise during chemistry and pharmacy data documentation requirements for drug development in order to be able to provide effective advice on such situations where this data is prepared

• Explore and understand the regulatory issues likely to arise during chemistry and pharmacy data documentation requirements for drug development in order to be able to provide effective advice on such situations where this data is prepared.

learning outcomes


• display a systematic understanding of knowledge, and a critical awareness of the chemistry and pharmacy data requirements and interpretation during development of a new chemical active substance

• possess a comprehensive understanding of good manufacturing processes in formulation and the validation requirements in the context of drug development

• demonstrate conceptual understanding of the legal and regulatory requirements for the development of a new active substance including Eu clinical directives, global legislation and guidelines to evaluate critically current research.


• demonstrate the ability to critically analyse the legal documentation and regulatory considerations for the chemistry and pharmacy data required for developing the specifications for the drug product


• critically appraise and evaluate communications from regulatory bodies and research publications covering chemistry and pharmacy data.

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Module 7FHH1101 regulatory strategy for a new active substance: global clinical development

module aims:


• consider and understand regulatory strategy aspects of global clinical research

• Explore and review the global regulatory issues likely to arise during global clinical programmes in order to be able to provide effective advice on such situations.

learning outcomes


• possess a systematic understanding of knowledge, and a critical awareness of the regulations and international directives pertaining to clinical development of a new medicine

• show a critical awareness of the clinical programme strategies which can be employed during development and registration of a new medicine of clinical programme strategy, and effective regulatory leadership throughout the clinical development and the registration of a new medicine

•��display a comprehensive understanding of the procedures and regulatory requirements for analysis of Eu clinical directives, clinical trial reports and summaries for optimal product labelling

•� Evaluate methodologies and develop critiques of the medical, statistical, economic and operational aspects of clinical trial programmes.


•� demonstrate the ability to critically analyse the legal documentation and global operational clinical trial programme considerations of clinical research

•� Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences

•� critically appraise and evaluate global clinical research communications from regulatory bodies and research publications.

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Module 7FHH1101 regulatory strategy for a new active substance: global clinical development

Module 7FHH1102 regulatory control of clinical operations

module aims:


• consider and develop an understanding of regulatory aspects of global clinical research

• Explore and appreciate the regulatory issues likely to arise during clinical programmes in order to be able to provide effective advice on such situations.

learning outcomes


• develop a systematic understanding of knowledge, and a critical awareness of the practical aspects of good clinical practice, good manufacturing practice and pharmacovigilance in the context of clinical research

• Evaluate critically current regulatory requirements, Eu clinical directives, clinical trial authorisation and associated documentation

• demonstrate an in depth knowledge and comprehensive understanding of the legal and ethical aspects of clinical research and importation of medicinal products.


• demonstrate the ability to critically analyse the legal documentation and ethical considerations of clinical research


• critically appraise and evaluate communications from regulatory bodies and research publications.

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Module 7FHH1103 regulatory strategy: the market place

module aims:


•��consider and appreciate regulatory aspects of regulatory strategy for commercialising products and maintaining the brand

•��Explore and understand the regulatory issues likely to arise during commercialising of products in order to be able to provide effective advice on such situations.

learning outcomes


•��have a conceptual understanding that enables the student to evaluate critically the different approaches to product lifecycle management and drug development

•��possess a critical knowledge of the regulatory requirements, directives and international requirements for commercialising products and maintaining the brand

•��demonstrate an in depth knowledge and critical awareness of the legal and ethical aspects of lifecycle management of medicinal products.


•��demonstrate the ability to critically analyse the legal documentation considerations of lifecycle management including promotion, otc and safety reporting

•��select and examine appropriate methods of communication of complex data regarding commercialised products for dissemination to both non regulatory experts and regulatory experts including the spc data

•��critically appraise and evaluate communications from regulatory bodies and research publications regarding commercialised medicinal products.

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Module 7FHH1103 regulatory strategy: the market place

Module 7FHH1104 regulatory strategy for Established active substances

module aims:


• consider and understand regulatory aspects of regulatory strategy for established active substances

• Explore and review the regulatory issues likely to arise for established active substances in order to be able to provide effective advice on such situations.

learning outcomes


• display systematic understanding of knowledge, and a critical awareness of the strategies for approval of established active substances in the context of abridged applications and otc products

• have a critical understanding of the regulatory requirements, directives, and associated documentation associated with established active substance approval

• demonstrate a conceptual understanding of the legal requirements for approval of established medicinal products as otc products that enables the student to evaluate critically current research and advanced scholarship in the discipline.


• demonstrate the ability to critically analyse the legal documentation and regulatory considerations of established active substances

• Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding established actives substances

• critically appraise and evaluate communications from regulatory bodies and research publications regarding established active substances.

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Module 7FHH1105 data requirements for abridged applications and specialised products

module aims:


•��consider and evaluate practical regulatory aspects of regulatory strategy for abridged applications and specialised products

•��Explore and critically debate the regulatory issues likely to arise for abridged applications and specialised products in order to be able provide effective advice on such situations.

learning outcomes


•��develop a systematic understanding of knowledge, and a critical awareness of the legal requirements for development and marketing of established active substances in the context of abridged applications and specialised products

•��have a conceptual understanding of the processes and strategies to comply with the regulatory requirements, directives, and associated documentation with the strategy for abridged applications and specialised products

•��critically evaluate current research and advanced scholarship in the discipline.


•��demonstrate the ability to critically analyse the legal documentation and regulatory considerations of abridged applications and specialised products

•��Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding abridged applications and specialised products

•��critically appraise and evaluate communications from regulatory bodies and research publications regarding abridged applications and specialised products.

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Module 7FHH1105 data requirements for abridged applications and specialised products

Module 7FHH1106 registration of biological, biotechnology and advanced therapy products

module aims:


•��consider and understand regulatory aspects of regulatory strategy for biological, biotechnology and advanced therapy products

•��Explore and appreciate the regulatory issues likely to arise for biological, biotechnology and advanced therapy products in order to be able provide effective advice on such situations.

learning outcomes


•��display a systematic understanding of knowledge, and a critical awareness of the unique nature and strategies for development of biological, biotechnology and advanced therapy products

•��possess a comprehensive understanding of the regulatory requirements and associated documentation with the licensing of biological, biotechnology and advanced therapy products

•��demonstrate a conceptual understanding of the legal and pharmaceutical requirements that define the regulatory strategy for biological, biotechnology and advanced therapy products.


•��demonstrate the ability to critically analyse the legal documentation and regulatory considerations of biological, biotechnology and advanced therapy products

•��Evaluate complex issues both systematically and creatively, make sound judgments in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding biological, biotechnology and advanced therapy products

•��critically appraise and evaluate communications from regulatory bodies and research publications regarding biological, biotechnology and advanced therapy products.

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Module 7FHH1107 optimising the contribution of ra to product development

module aims:


•��consider and appreciate regulatory aspects of the management of the strategy for product development, maintenance and commercialisation

•��Explore and understand the management issues likely to arise for product development, maintenance and commercialisation in order to be able to provide effective advice on such situations.

learning outcomes


•��develop a systematic understanding of knowledge, and a critical awareness of the practical aspects of regulation for product development, maintenance and commercialisation

•��display a critical knowledge of documentation used in development, maintenance and commercialisation of medicinal products

•��possess a comprehensive understanding of legal requirements and management theory governing regulatory strategies for product development, maintenance and commercialisation.


•��demonstrate the ability to critically analyse the management considerations of product development, maintenance and commercialisation

•��Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences to optimise product development, maintenance and commercialisation

•��critically appraise and evaluate communications from research and other publications regarding the management of product development, maintenance and commercialisation.

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Module 7FHH1107 optimising the contribution of ra to product development

Module 7FHH1108 the us regulatory Environment

module aims:


•�consider and understand regulatory aspects of regulatory affairs in the us

•��Explore and appreciate the regulatory issues likely to arise during drug development in order to be able to provide effective advice on the regulatory affairs activities involved with drug development in the us.

learning outcomes


•��possess a systematic understanding of knowledge, and a critical awareness of the regulatory environment and procedures governing regulatory approval of clinical trials in the us and regulatory marketing authorisation in the context of drug development

•��demonstrate a conceptual understanding of the regulatory requirements, fda requirements, regulatory authorisation and associated documentation for marketing submissions.


•��display originality in the application of knowledge of the us regulatory aspects of drug development to evaluate critically current research in the discipline

•�demonstrate the ability to critically analyse the legal documentation for us drug development

•��Evaluate complex issues related to us regulatory authorisation, both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences

•��critically appraise and evaluate communications from regulatory bodies (such as the fda) and critically evaluate research publications.

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Module 7FHH1109 medical device regulatory affairs

module aims:


•��consider and develop an appreciation of regulatory aspects of regulatory strategy for medical devices

•��Explore the regulatory issues likely to arise for medical devices in order to be able provide effective advice on such situations.

learning outcomes


•��possess a systematic understanding and critical awareness of the regulatory requirements, directives, and associated documentation relating to medicinal device products

•��demonstrate a conceptual understanding of the strategies for development and marketing of medicinal device products such that they can be critiqued and alternative hypothesis developed

•��demonstrate a critical knowledge of the legal and other aspects of the regulatory strategy for medical device products.


•��demonstrate the ability to critically analyse the legal documentation and regulatory considerations of medical devices

•��Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences

•��critically appraise and evaluate communications from regulatory bodies and research publications regarding medical devices.

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Module 7FHH1109 medical device regulatory affairs

Module 7FHH1110 dissertation

module aims:


•��complete a substantial piece of work which demands the use of appropriate methods of inquiry and skills to critically evaluate a practice issue or policy related to the discipline of study

•��define and evaluate alternative perspectives for addressing a particular practice issue.

learning outcomes


•��make effective use of, and be critical of, alternative sources of information that contribute to existing knowledge on the selected topic

•��develop critical understanding by application of research evidence in the examination of perspectives related to the chosen topic

•��demonstrate ability to critically reflect on the influence of self and local practice environment on the chosen topic.


•��demonstrate ability to design and conduct systematic investigation into a specific area of practice by using appropriate and rigorous methods

•��demonstrate the skills to apply critical analysis, synthesis and integration of theory and practice in the discipline of study.

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Notes

msc in regulatory affairsValidated by the University of Hertfordshire

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The MSc in Regulatory Affairs offered by

TOPRA and now validated by the University of

Hertfordshire, provides a unique opportunity

to study aspects of regulatory affairs at an

advanced level.

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Bellerive House, 3 Muirfield Crescent,

London E14 9SZ

tel: +44 (0)20 7510 2560

fax: +44 (0)20 7537 2003

Email: [email protected]

Website: www.topra.org

TOPRA – The Organisation for Professionals in

Regulatory Affairs Ltd. Registered in England company

number 1400379. A company limited by guarantee

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TOPRA MSc prospectus 2013