PROSPECTUS - MSc REGULATORY AFFAIRS MEDICINES / MEDICAL DEVICES
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MSc REGULATORY AFFAIRS MEDICINES / MEDICAL DEVICES PROSPECTUS
ABOUT THE MSc
ABOUT US MSc REGULATORY AFFAIRS
MEDICINES/MEDICAL DEVICES
The Organisation for Professionals in
Regulatory Affairs has been running the CONTENTS
The TOPRA MSc Regulatory Affairs programme is designed for regulatory professionals who
TOPRA MSc Regulatory Affairs more than 25
have already gained first-hand experience of regulatory affairs and wish to increase the
years, and has been working in partnership
About the MSc 1 breadth and/or depth of their knowledge.
with the University of Hertfordshire to offer
this well-respected programme since 2013.
What’s Involved 2 It is a part-time flexible programme that is continually adapted to meet the ever-changing
TOPRA and UH are pleased to announce demands of the regulatory healthcare environment. Students can choose from 22 modules
the new MSc programme which offers two Why Do An MSc With TOPRA? 5 to ensure the overall programme is tailored to consolidate their own professional practice
pathways – Medicines and Medical Devices and provides development opportunities particularly for those who are at the stage of
– offering a much expanded curriculum and Pathway – Medicines 6 consolidating or driving their career (see page 52).
greater flexibility for students.
The new programme has been validated by Pathway – Medical Devices 32 The MSc RA programme is unique in that all content is designed, structured and delivered
UH, which has a strong track record in Life by senior regulatory professionals from both industry and regulatory bodies, which means
and Medical Sciences. It has developed Dissertation 50 it always covers the most up-to-date and relevant issues facing regulatory professionals in
a Pharmaceutical Science programme in their everyday practice. This also ensures all graduates have an in-depth knowledge and
collaboration with a range of local and national Career Pathways 52 appreciation of various subjects directly relevant to them. The modules provide regulatory
companies, from small biotech companies to knowledge as well as the skills required to be a highly effective regulatory professional, such
multinational pharmaceutical giants. Case Studies 53 as leadership, strategic thinking, management and negotiation.
TOPRA is the professional membership
organisation for individuals working in The MSc RA programme has been updated and revalidated by the University of Hertfordshire
healthcare regulatory affairs. TOPRA works to include two pathways: Regulatory Affairs (Medicines) and Regulatory Affairs (Medical
with members internationally to enable and Devices). Students on either pathway have the opportunity to take up to two modules from
promote excellence across the healthcare the other pathway – enabling greater flexibility to broaden their regulatory expertise across
regulatory profession. specialties.
“I would recommend the regulatory MSc to other colleagues,
INVESTING FOR THE FUTURE because it gives an overview of the different areas within regulatory
TOPRA is committed to providing regulatory professionals
in a short period of time. With this comes confidence dealing with
with continuing education opportunities in order to
deliver better, safer healthcare for patients .The new different situations and, as we all know, no two days are the same
upadated MSc RA is a key element of our TOPRA 2020 in regulatory life”
initiative.
EXCELLENCE
Developing regulatory excellence
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 1WHAT’S INVOLVED MEDICINES PATHWAYS
ENTRY REQUIREMENTS COURSE STRUCTURE MODULE 0 Overview of EU Regulatory Affairs
The normal entry requirements for the The MSc RA programme is offered in part-time MODULE 1 Strategic Planning in Regulatory Affairs
programme are a BSc (Hons) – normally mode taking 1-6 years, depending on the final
a minimum classification of 2:2 – in an award (see below). MODULE 2 Regulatory Strategy for a New Active Substance: Nonclinical Development
appropriate scientific discipline (or equivalent
qualification from a recognised educational Students may join the programme at the MODULE 3 Regulatory Requirements for a New Active Substance: Quality
institution) and the candidate must be able start of any of the scheduled modules as
to demonstrate that they have sufficient the programme does not follow a traditional MODULE 4 Regulatory Strategy for a New Active Substance: Global Clinical Development
regulatory experience to benefit from the semester entry format. Modules run on a
programme. three-year cycle with a total of five medicines
MODULE 5 Regulatory Strategy for a New Active Substance: Global Clinical Development
modules, including the Overview of EU
However, candidates with limited regulatory
MODULE 6 Regulatory Strategy: From Development to the Market Place
Regulatory Affairs (Module 0), which runs runs
affairs experience or who have experience but twice a year, and four medical devices modules MODULE 7 Regulatory Strategy for Established Active Substances
do not have a degree may be considered – taking place each year (see page 4).
contact mscadmin@topra.org to discuss your MODULE 8 Data for Abridged Applications and Specialised Products
individual circumstances. Students for either the Medicines or Medical
Device pathway can take up to two modules MODULE 9 Registration of Biological, Biotechnology and Advanced Therapy Products
An IELTS (International English Language from the other pathway to allow great flexibility
Testing System) certificate 6.5 overall (with no in tailoring their qualification. MODULE 10 Leadership and Strategic Management in Regulatory Affairs
individual component below 6.0) will normally
be required for applicants whose first language Students not wishing to commit to the full MSc MODULE 11 The US Regulatory Environment
is not English. The Course Director and the are able to register for a postgraduate diploma
Collaborative Partnership Leader may consider (requires eight modules), or a postgraduate MODULE 12 Data Management and Digitalisation in Regulatory Affairs
the candidate’s proficiency has been proven certificate (requires four modules). Students
by their regulatory work output in English and/ registering for the postgraduate certificate
or through working and living in the UK or in a
company that only communicates in English.
may take any four modules from either the
Medicines or Medical Device pathways.
MEDICAL DEVICES PATHWAYS
Any student who has registered for the PG Dip
The programme is subject to the university’s or PG Cert can transfer onto the full
Principles, Policies and Regulations for the MSc programme (see page 4).
MODULE 13 Principles of Medical Device Regulatory Affairs
Admission of Students to Undergraduate and
Taught Postgraduate Programmes (in UPR
MODULE 14 Design, Development and Certification of Medical Devices
SA03), along with associated procedures.
MODULE 15 Clinical Evaluation of Medical Devices
These will take account of university policy
and guidelines for assessing accredited prior MODULE 16 Post Market Surveillance and Vigilance for Medical Devices
certificated learning (APCL) and accredited
prior experiential learning (APEL). MODULE 17 Regulatory Strategy in the Post Market Phase
MODULE 18 Drug-device Combinations and Other Technologies
MODULE 19 Regulation of In vitro Diagnostic Medical Devices
MODULE 20 Regulation of Electrical, Electronic and Software Devices
MODULE 21 US Regulation of Medical Devices
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 3WHAT’S INVOLVED WHY DO AN MSc WITH TOPRA?
ASSESSMENTS AWARDS TOPRA is committed to supporting regulatory professionals to perform at the highest
Following each module the student must > The award of an MSc requires 180 credit level – and does this via a wide range of professional development activities. TOPRA’s
complete coursework assignments related points* passed at Level 7 including the postgraduate programme – which offers postgraduate qualifications from Certificate to
to the module topic. The coursework is assessed dissertation.
> The award of a Pg Dip requires 120 credit PhD – has been developed by regulatory professionals for regulatory professionals. All
at defined times during the academic year in module leaders are practising experts in their field offering up-to-date, tailored courses
points passed at Level 7.
which the modules are undertaken (see table > The award of a Pg Cert requires 60 credit in a wide range of regulatory specialties.
below for timings of the modules). points passed at Level 7.
MSc Regulatory Affairs (Medicines)
Submission dates for the course journals and > Compulsory – dissertation This updated flexible MSc RA (Pharmaceutical/Medical Devices) enables students to
assignments are given at each individual module. > Students must pass at least 6 modules from build a postgraduate qualification to drive their future career. Students benefit from the
A maximum period of three months is allowed for modules 0–12 best of both worlds – by being aligned with a global professional body with the support
completion of the coursework. > Students may take up to 2 modules from of the University of Hertfordshire, a world-class academic institution.
modules 13–21
Pg Dip Regulatory Affairs (Medicines)
Students are required to satisfy the examiners
with respect to the coursework prepared for each
> Students must pass at least 6 modules from ACADEMIC RESOURCES
modules 0–12 All TOPRA’s MSc students have access not only to the UH library, but to the Royal
module undertaken. Should a candidate fail to > Students may take up to 2 modules from
satisfy the Board of Examiners, coursework may modules 13–21 Pharmaceutical Society Library and other academic libraries (access arranged via
be resubmitted within a timeframe stipulated by MSc Regulatory Affairs (Medical Devices) TOPRA), as well as to SCONUL (www.access.sconul.ac.uk) which allows borrowing
the Board. > Compulsory – dissertation facilities for part-time, distance and placement students.
> Students must pass at least 6 modules from
modules 10, 13–21
DISSERTATION > Students may take up to 2 modules from Students also have access to StudyNet, UH’s MLE (managed learning environment), in
Following successful completion of eight modules 0–12 order to access to all information relevant to their studies and communicate with other
modules, students must submit a research-based Pg Dip Regulatory Affairs (Medical Devices) students via a discussion forum. StudyNet thus provides a vital link between teaching
MSc dissertation (Module 22) of 18,000–20,000 > Compulsory – dissertation staff and students.
words to achieve the MSc award (see page 50). > Students must pass at least 6 modules from
modules 10, 13–21
MODULE SCHEDULES > Students may take up to 2 modules from SUPPORT MECHANISMS
Students can take plan when to take particular modules 0–12
PG Cert Regulatory Affairs
At their first module, all students attend a mandatory tutorial meeting and from then
modules from the table below. onwards they can contact the Course Director (and Dissertation Academic Adviser for
> Students must pass at least 4 modules from
modules 0–21. Dissertation student support) via telephone and email.
Jan–Feb Mar–Apr May–Jul Sept–Oct Nov–Dec Each student is encouraged to use Personal Development Planning (PDP) which is
2017 9, 19 0, 1 3, 13, 14 2 0, 4, 15 a process of recording and reflecting on their skills and experience which will to help
2018 5, 12 0, 6, 16 7, 13, 17 11, 18 0, 8 plan their personal, educational, and career development. Both TOPRA and UH are
on hand to offer access to careers advice.
2019 10, 19 0, 9 1, 13, 20 2, 21 0, 3, 12
2020 4, 14 0, 5 6, 13, 15 7, 16 0, 11, 17 The university offers a professional counselling support service, equal opportunities
2021 8, 18 0, 10 9, 13, 19 1, 20 0, 2, 21 advice, and disability services (contact TOPRA or UH for details).
2022 3, 12 0, 4 5, 13, 14 6, 15 0, 7, 16
Some students may be eligible for a UK Government postgraduate loan. Please see the
2023 8, 17 0, 11 10, 13, 18 9, 19 0, 1, 20 government’s website Postgraduate Loans for further information.
2024 2, 21 0, 3 4, 12, 13 5, 14 0, 6, 15
2025 7, 16 0, 11 8, 13, 17 10, 18 0, 9, 19
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 5MODULE 0 LEARNING OUTCOMES
OVERVIEW OF EU KNOWLEDGE AND UNDERSTANDING
REGULATORY AFFAIRS Successful students will typically:
> Demonstrate a conceptual understanding of the regulatory
To provide a brief overview of the many aspects requirements: EU directives and legislation; regulatory
of regulation of medicines in Europe, enabling authorisation and associated documentation for marketing
attendees to understand the legislative submissions to evaluate current developments critically
framework and practical aspects of EU
pharmaceutical regulatory affairs. > Display a comprehensive understanding of the EU regulatory
aspects of drug development
CONTENT
This module is designed for regulatory > Possess a systematic understanding of knowledge, and
professionals to develop and deepen their a critical awareness of the regulatory environment and
understanding of all aspects of regulatory procedures governing regulatory approval of clinical trials
operations in the EU, and the role of the in the EU and regulatory marketing authorisation in the
regulatory affairs function. It will allow them to context of drug development.
examine the regulatory requirements imposed
on drug development, the processes of SKILLS AND ATTRIBUTES
preparing regulatory documentation for clinical
trial authorisation and marketing authorisation. Successful students will typically:
> Demonstrate the ability to critically analyse the legal
documentation and guideline considerations of EU
regulatory affairs
> Deal with 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.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 7MODULE 1 LEARNING OUTCOMES
STRATEGIC PLANNING KNOWLEDGE AND UNDERSTANDING
IN REGULATORY AFFAIRS Successful students will typically:
> Demonstrate a systematic understanding of knowledge in, and
To enable students to understand the practical a critical awareness of the theory and practice of global strategic
and strategic aspects of global regulatory planning strategies as they relate to obtaining regulatory marketing
affairs, helping them develop sufficient authorisation and pricing negotiations
knowledge and skills to provide advice to their
companies and contribute to regulatory strategy. > Display critical knowledge of the regulatory requirements, global
legislation, regulatory authorisation and associated documentation
CONTENT for planning drug development programmes
This module is designed to develop and
deepen students’ understanding of all aspects > Demonstrate an in-depth conceptual understanding of strategic
of the management of global regulatory plans for the regulatory approval of drug development programmes.
operations and strategic planning. It enables
them to examine the strategic regulatory SKILLS AND ATTRIBUTES
options for planning global drug development Successful students will typically:
programmes, the interactions between the > Critically appraise and evaluate communications from regulatory
companies and the regulatory agencies, the bodies and research publications for the management of regulatory
processes of preparing strategic regulatory affairs and strategic planning in drug development
documentation for gaining marketing
authorisation and commercialisation > Demonstrate the ability to critically analyse the legal documentation
of a product. and regulatory consideration of drug development
> Deal with complex issues both systematically and creatively, make
sound judgements in the absence of complete data, and
communicate their conclusions clearly to specialist and
“You can pick the different modules you non-specialist audiences regarding planning regulatory strategies
want to study. This flexibility is useful as you for drug development programmes for regulatory authorisation and
can choose ones you do not have experience marketing approval.
with to broaden your knowledge”
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 9MODULE 2 LEARNING OUTCOMES
REGULATORY STRATEGY FOR KNOWLEDGE AND UNDERSTANDING
A NEW ACTIVE SUBSTANCE: Successful students will typically:
> Develop a systematic understanding and a critical
NONCLINICAL DEVELOPMENT awareness of the practical aspects of nonclinical development,
To enable students to understand the practical types and design of nonclinical safety studies and pharmacokinetic
and legislative requirements for the nonclinical requirements in the context of the nonclinical
phase of global drug development. It explores research phase of drug development
regulatory issues that are likely to arise
and provides advice and discussion around > Demonstrate a comprehensive understanding of the nonclinical
solutions to such situations. regulatory requirements, nonclinical guidelines and other
requirements for running nonclinical drug safety studies
CONTENT
This module is designed to develop and deepen > Have a conceptual understanding of the legal and ethical
regulatory professionals’ understanding of all aspects of nonclinical research and the importance of critical
aspects of the nonclinical development for evaluation of the study designs and data generated during
a new active substance. It enables them to research on medicinal products.
examine the nonclinical regulatory requirements
imposed on drug development, the processes SKILLS AND ATTRIBUTES
of preparing documentation for the nonclinical Successful students will typically:
dossier, including considerations for the > Demonstrate the ability to critically analyse the nonclinical
nonclinical study reports and summaries. regulatory documentation and guidelines for the nonclinical
part of drug development.
> Deal with 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
nonclinical data.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 11MODULE 3 LEARNING OUTCOMES
REGULATORY REQUIREMENTS KNOWLEDGE AND UNDERSTANDING
FOR A NEW ACTIVE SUBSTANCE: Successful students will typically:
QUALITY > Display a systematic understanding of chemistry and pharmacy
data requirements with the knowledge to interpret them during
To enable students to understand quality data development of a new chemical active substance
requirements in the pharmaceutical regulatory
environment so they can address practical > Possess a comprehensive understanding of good manufacturing
regulatory questions in this area and offer processes in formulation and the validation requirements in the
advice to colleagues. context of drug development
CONTENT > Demonstrate conceptual understanding of the legal and
This module is designed for regulatory regulatory requirements for the development of a new active
professionals to develop and deepen their substance including EU clinical directives, global legislation
understanding of all aspects of the regulation and guidelines to evaluate critically current research.
of chemistry and pharmacy data. It will allow
them to examine the regulatory requirements SKILLS AND ATTRIBUTES
imposed on preparing chemistry and pharmacy Successful students will typically:
data, the processes of preparing chemistry and > Demonstrate the ability to critically analyse the legal
pharmacy documentation such as the Common documentation and regulatory considerations for the chemistry
Technical Document, IMPDs and INDs. and pharmacy data required for developing the specifications
for the drug product
> Deal with complex issues both systematically and creatively,
make sound judgements in the absence of complete data,
and communicate their conclusions clearly to specialist and
“Doing the MSc gives you confidence to deal non-specialist audiences
with a large amount of information, become
familiar with where to go to get information > Critically appraise and evaluate communications from regulatory
about different regulations etc, and summarise bodies and research publications covering chemistry and
information quickly” pharmacy data.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 13MODULE 4 LEARNING OUTCOMES
REGULATORY STRATEGY FOR KNOWLEDGE AND UNDERSTANDING
A NEW ACTIVE SUBSTANCE: Successful students will typically:
> Possess a systematic understanding and critical awareness of
GLOBAL CLINICAL DEVELOPMENT the regulations and international directives pertaining to clinical
development of a new medicine
To enable students to understand and develop
regulatory strategies for all aspects of global > Show a critical awareness of the clinical programme strategies,
clinical research, as well as addressing practical which can be employed during development and registration
regulatory issues in this area. of a new medicine, and exhibit effective regulatory leadership
throughout clinical development and the registration of a
CONTENT new medicine
This module is designed for regulatory
professionals to develop and deepen their > Display a comprehensive understanding of the EU legislation on the
understanding of all aspects of the regulation different aspects of clinical development, and of the procedures and
of global clinical development. It allows them to regulatory requirements for clinical trial reports, clinical overview and
examine the regulatory requirements imposed on summary documents for optimal product labelling
clinical development; the processes of preparing
documentation for clinical study reports and > Evaluate methodologies and develop critiques of the medical, statistical,
regulatory overview summary documents; and economic and operational aspects of clinical trial programmes.
strategic considerations for the running of
international clinical trial programmes. SKILLS AND ATTRIBUTES
Successful students will typically:
> Demonstrate the ability to critically analyse the legal documentation
relating to global operational clinical trial programme considerations
of clinical research
> Deal with 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.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 15MODULE 5 LEARNING OUTCOMES
REGULATORY CONTROL OF KNOWLEDGE AND UNDERSTANDING
CLINICAL OPERATIONS Successful students will typically:
> Develop a systematic understanding and a critical awareness of the
To enable students to consider and evaluate practical aspects of good clinical practice (GCP), good manufacturing
practical regulatory aspects of global clinical practice (GMP), ISO 14155 and pharmacovigilance in the context of
research; and explore and critically debate the clinical research
regulatory issues likely to arise during clinical
programmes in order to be able to provide > Critically evaluate the current regulatory requirements, EU clinical
effective advice on such situations. directives/regulations, clinical trial authorisation and associated
documentation for both pharmaceuticals and devices
CONTENT
This module is designed for regulatory > Demonstrate in-depth knowledge and comprehensive understanding
professionals to develop and deepen their of the legal and ethical aspects of clinical research and importation
understanding of all aspects of the regulation of medicinal products/medical devices.
of clinical operations. It will allow them to
examine the regulatory requirements imposed SKILLS AND ATTRIBUTES
on clinical research, the processes of preparing
documentation for clinical trial authorisation Successful students will typically:
and the ethical and legal considerations. In > Demonstrate the ability to critically analyse the legal documentation
particular, the module will impart the ability and ethical considerations of clinical research
to critically appraise actions and report
recommendations on the appropriateness > Deal with complex issues both systematically and creatively,
of strategies in clinical research. 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.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 17MODULE 6 LEARNING OUTCOMES
REGULATORY STRATEGY: KNOWLEDGE AND UNDERSTANDING
FROM DEVELOPMENT TO Successful students will typically:
> Have a conceptual understanding that enables them to evaluate
THE MARKET PLACE critically the different strategic approaches to product lifecycle
To enable students to consider and evaluate management and drug development
practical regulatory aspects of regulatory
strategy for commercialising products and > Possess a critical knowledge of the regulatory requirements,
maintaining the brand from development stages directives and international requirements for commercialising
to registration and throughout the product products and maintaining the brand
lifecycle; and explore and critically debate the
regulatory issues likely to arise before and > Demonstrate an in-depth knowledge and critical awareness of the
during commercialisation of products in order to legal and ethical aspects of lifecycle management of medicinal
be able to provide effective advice as necessary. products.
CONTENT SKILLS AND ATTRIBUTES
This module enables regulatory professionals to Successful students will typically:
develop and deepen their understanding of all > Demonstrate the ability to critically analyse the legal documentation
aspects of the regulatory strategic issues related considerations of maintaining and managing the brand through
to defining and shaping the brand, protecting lifecycle management, including advertising and promotion,
and maintaining brand awareness throughout changing legal status and safety reporting
the product lifecycle. It allows them to examine
the regulatory requirements imposed on > Select and examine appropriate methods of communication of
commercial medicinal products. complex data regarding commercialised products for dissemination
to both non-regulatory experts and regulatory experts, including the
SmPC (summary of product characteristics) data
“Nice to get to deliberate (in the case studies)
> Critically appraise and evaluate communications from regulatory
with colleagues from different companies and
bodies and research publications regarding commercialised
agencies. Different opinions were circulated
medicinal products.
and I learned a lot from this exercise”
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 19MODULE 7 LEARNING OUTCOMES
REGULATORY STRATEGY FOR KNOWLEDGE AND UNDERSTANDING
ESTABLISHED ACTIVE Successful students will typically:
> Display systematic understanding and critical awareness of the
SUBSTANCES strategies for approval of established active substances in the
To enable students to consider and evaluate context of abridged applications and OTC products
practical aspects of regulatory strategy for
established active substances; > Have a critical understanding of the regulatory requirements,
and explore and critically debate the regulatory directives and associated documentation associated with
issues likely to arise for established active established active substance approval
substances in order to be able to provide
effective advice. > Demonstrate a conceptual understanding of the legal requirements
for approval of established medicinal products as OTC products in
CONTENT order to evaluate critically the current research and advanced
This module enables regulatory professionals scholarship in the discipline.
to develop and deepen their understanding
of all aspects of the regulations and the SKILLS AND ATTRIBUTES
strategic issues to be considered in relation Successful students will typically:
to medicines containing established active > Demonstrate the ability to critically analyse the legal documentation
substances, including line extensions, generics and regulatory considerations of established active substances
and the relevant aspects for over-the-counter
(OTC) products. It allows them to examine > Deal with complex issues both systematically and creatively, make
the regulatory requirements imposed on sound judgements in the absence of complete data, and
established active substances. communicate their conclusions clearly to specialist and non-specialist
audiences regarding established active substances
> Critically appraise and evaluate communications from regulatory
bodies and research publications regarding established
active substances.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 21MODULE 8 LEARNING OUTCOMES
DATA FOR ABRIDGED KNOWLEDGE AND UNDERSTANDING
APPLICATIONS AND Successful students will typically:
> Develop a systematic understanding of knowledge, and a critical
SPECIALISED PRODUCTS awareness of the legal requirements for development and marketing
To enable students to consider and evaluate of established active substances in the context of abridged
practical aspects of regulatory strategy for applications and specialised products
abridged applications and specialised products;
and explore and critically debate the regulatory > Have a conceptual understanding of the processes and strategies
issues likely to arise for abridged applications to comply with the regulatory requirements, directives, and
and specialised products in order to provide associated documentation with the strategy for abridged applications
effective advice in this area. and specialised products that enables them to evaluate critically
current research and advanced scholarship in the discipline
CONTENT
This module enables regulatory professionals > Be able to identify, evaluate and connect the chemical/pharmaceutical,
to develop and deepen their understanding nonclinical and clinical data required for abridged applications and
of all aspects of the regulation, the issues specialised products.
and the diversity of abridged applications.
It also outlines the data requirements for a SKILLS AND ATTRIBUTES
variety of different new dosage forms and Successful students will typically:
new indications. The data requirements for > Demonstrate the ability to critically analyse the legal documentation
certain specialised products are also covered. and regulatory considerations of abridged applications and
It allows students to examine the regulatory specialised products
requirements imposed on abridged applications
and specialised products. > Deal with 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
“Very good course to give an insight into data
requirements for abridged applications and > Critically appraise and evaluate communications from regulatory
specialised products” bodies and research publications regarding abridged applications
and specialised products.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 23MODULE 9 LEARNING OUTCOMES
REGISTRATION OF BIOLOGICAL, KNOWLEDGE AND UNDERSTANDING
BIOTECHNOLOGY AND Successful students will typically:
> Display a systematic understanding of knowledge, and a critical
ADVANCED THERAPY PRODUCTS awareness of the unique nature and strategies for development of
To enable students to consider and evaluate biological, biotechnology and advanced therapy products
practical aspects of regulatory strategy for
biological, biotechnology and advanced therapy > Possess a comprehensive understanding of the regulatory
products; and explore and critically debate the requirements and associated documentation with the licensing of
regulatory issues likely to arise for biological, biological, biotechnology and advanced therapy products
biotechnology and advanced therapy products
in order to provide effective advice on such > Demonstrate a conceptual understanding of the legal and
situations. pharmaceutical requirements that define the regulatory strategy for
biological, biotechnology and advanced therapy products.
CONTENT
This module enables regulatory professionals SKILLS AND ATTRIBUTES
to develop and deepen their understanding of Successful students will typically:
all aspects of the regulation of the issues of the > Deal with complex issues both systematically and creatively, make
scientific principles underpinning development sound judgements in the absence of complete data, and
of biological/biotechnology products and how communicate their conclusions clearly to specialist and non-
the inherent complexities impact on regulation. specialist audiences regarding biological, biotechnology and
It also considers the data requirements for advanced therapy products
biological, biotechnology and advanced therapy
products and allows students to examine the > Demonstrate the ability to critically analyse the legal documentation
regulatory requirements imposed on biological, and regulatory considerations of biological, biotechnology and
biotechnology and advanced therapy products. advanced therapy products
> Critically appraise and evaluate communications from regulatory
bodies and research publications regarding biological, biotechnology
and advanced therapy products.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 25MODULE 10 LEARNING OUTCOMES
LEADERSHIP AND STRATEGIC KNOWLEDGE AND UNDERSTANDING
MANAGEMENT IN Successful students will typically:
> Develop a systematic understanding and critical awareness of
REGULATORY AFFAIRS the practical management aspects of running a regulatory affairs
To enable students to consider and evaluate department responsible for product development, maintenance
practical aspects of leadership and management and commercialisation
required to run a successful regulatory affairs
> Demonstrate a critical knowledge of how to liaise and collaborate
department, which is responsible for the
with other departments to ensure the appropriate documentation
regulatory strategy for product development,
used in development, maintenance and commercialisation of
maintenance and commercialisation. It allows
healthcare products is in place
them to explore and critically debate the
management issues likely to arise in running > Possess a comprehensive understanding of the legal requirements
a successful regulatory affairs department in and management theory governing regulatory strategies for product
order to be a key contact for main stakeholders development, maintenance and commercialisation.
and bring competitive advantage to the
company.
SKILLS AND ATTRIBUTES
CONTENT Successful students will typically:
This module enables regulatory professionals > Demonstrate the ability to understand the management and leadership
to develop and deepen their understanding of skills required to run a regulatory affairs department as a manager,
all aspects of the management and leadership a leader or a member of the team
skills needed to run a successful regulatory
affairs department in order to bring competitive > Deal with complex issues both systematically and creatively, make
advantage to the company and the main sound management judgements in the absence of complete data,
stakeholders. and communicate their conclusions clearly to specialist and
non-specialist audiences, including working with other departments
> Critically appraise and evaluate communications from regulations,
guidelines, research and other publications regarding the
management of a regulatory affairs department.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 27MODULE 11 LEARNING OUTCOMES
THE US REGULATORY KNOWLEDGE AND UNDERSTANDING
ENVIRONMENT Successful students will typically:
> Possess a systematic understanding and critical awareness of the
To enable students to consider and evaluate regulatory environment and procedures governing regulatory approval
practical regulatory aspects of regulatory affairs of clinical trials in the US and regulatory marketing approval in the
in the US; and explore and critically debate context of drug development
the regulatory issues likely to arise during drug
development in order to be able to provide
> Demonstrate a conceptual understanding of the regulatory
effective advice on the regulatory affairs
requirements, FDA requirements, regulatory authorisation and
activities involved with drug development
associated documentation for marketing submissions
in the US.
> Display originality in the application of knowledge of the US
CONTENT regulatory aspects of drug development to critically evaluate
This module enables regulatory professionals current research in the discipline.
to develop and deepen their understanding
SKILLS AND ATTRIBUTES
of all aspects of regulatory operations in the
US. Its purpose is to provide students with an Successful students will typically:
understanding of the regulatory environment in > Demonstrate the ability to critically analyse the legal documentation
the US in order to place these global influences for US drug development
in perspective. > Critically appraise and evaluate communications from regulatory bodies
(such as the FDA) and critically evaluate research publications
> Deal with complex issues related to the 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.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 29MODULE 12 LEARNING OUTCOMES
DATA MANAGEMENT AND KNOWLEDGE AND UNDERSTANDING
DIGITALISATION IN Successful students will typically:
> Be able to explain the importance of data, document and
REGULATORY AFFAIRS information management and critically evaluate the IDMP
To enable students to understand the theoretical requirements
background to data management, document
management, electronic submissions, > Demonstrate a critical understanding of the processes and
eCompliance, regulatory information requirements necessary for completing an eCTD (electronic
management and the new Identification of common technical document)
Medicinal Products (IDMP) requirements, and
find solutions to practical problems in this > Demonstrate a conceptual understanding of data and document
area; and deal with large volumes of data and management in daily regulatory affairs work and identify issues
different data – from nonclinical to post-market with electronic compliance.
pharmacovigilance.
SKILLS AND ATTRIBUTES
CONTENT Successful students will typically:
Data management has always been a key part > Be able to make recommendations about regulatory information
of regulatory affairs from nonclinical data to management and IDMP strategies
post-market pharmacovigilance – and the
amount of data and the complexity of the data > Manage documents and data in an effective and efficient way
analysis is increasing. This module covers data
management in daily regulatory affairs work; > Critically analyse data and documentation strategies and processes
digitisation; EMA telematics strategy; eCTD;
EMA’s collaboration strategy; archiving of > Critically appraise regulatory processes and documentation
documents; CSV; regulatory information
management; regulatory intelligence and > Be able to explain the basis for electronic regulatory submissions.
knowledge management; IDMP; and big
data approaches to RA.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 31MODULE 13 LEARNING OUTCOMES
PRINCIPLES OF MEDICAL KNOWLEDGE AND UNDERSTANDING
DEVICE REGULATORY Successful students will typically:
> Demonstrate a conceptual understanding of the strategies for
AFFAIRS development and marketing of medical device products so they
To enable students to understand the legislative can be critiqued and alternative hypotheses developed
framework for the regulation of devices in
Europe and beyond; understand the practical > Demonstrate a critical knowledge of the legal and other aspects
aspects of regulatory strategy for medical of the regulatory strategy for medical device products
devices and be able to answer questions in this
area; and have an appreciation of the overall > Possess a systematic understanding and critical awareness of the
regulatory pathway and key requirements to regulatory requirements of directives, regulations and associated
market a medical device product in the EU. documentation relating to medical device products, with particular
emphasis on EU regulatory procedures.
CONTENT
This module enables regulatory professionals SKILLS AND ATTRIBUTES
to develop and deepen their understanding of Successful students will typically:
all aspects of regulation and strategic issues to > Deal with complex issues both systematically and creatively, make sound
be considered in relation to medical devices, judgements in the absence of complete data, and communicate their
including strategic advice on the application conclusions clearly to specialist and non-specialist audiences
of the EU medical device legislation to enable
products to be CE-marked. > Demonstrate the ability to critically analyse the legal documentation and
regulatory considerations of medical devices
> Critically appraise and evaluate communications from regulatory bodies
and research publications regarding medical devices.
“Good to have notified
body, competent
authority and industry
representatives”
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 33MODULE 14 LEARNING OUTCOMES
DESIGN, DEVELOPMENT AND KNOWLEDGE AND UNDERSTANDING
CERTIFICATION OF MEDICAL Successful students will typically:
> Be able to critically evaluate the design of a device including
DEVICES the materials it is made from
To enable students to demonstrate an
understanding of the development, > Demonstrate critical understanding of the safety and performance
manufacturing and GxP (good practice) of devices using applicable product standards for the EU and
requirements for product development so other global markets
that they can provide appropriate advice on
the key regulatory issues affecting the design > Critically evaluate the principles and practice of risk management
and manufacturing of medical devices; and to as set out in ISO 14971 to a level where they can apply it to a complex
understand the importance and concepts of medical device
risk management and the ways in which risk is
managed from the design stage onwards. > Be able to create and appraise the documents required to apply
for certification of medical devices for the EU and other global markets.
CONTENT
The module covers control of design and SKILLS AND ATTRIBUTES
development; input and output requirements Successful students will typically:
and the required documentation using example > Give appropriate advice to the medical device team on key regulatory
devices. It also looks at the impact of materials issues affecting the design, development and manufacturing
choice, design, verification, validation and of devices
certification of medical devices as well as the
applicable legislation, regulatory standards, > Produce the necessary technical documentation within
guidance and other documents (including GxP). project timeframes
Other topics include: packaging and labelling
(including unique device identification); > Critically appraise and evaluate communications from competent
biocompatibility and toxicology, risk management authorities, notified bodies and research publications covering
(including ISO 14971 and feedback of PMS data); the design, development and certification of medical devices globally.
and additive manufacturing and sterilisation.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 35MODULE 15 LEARNING OUTCOMES
CLINICAL EVALUATION KNOWLEDGE AND UNDERSTANDING
OF MEDICAL DEVICES Successful students will typically:
> Be able to critically evaluate existing literature and assess the need
To enable students to understand the broad for clinical evaluation
scope of clinical investigation and the regulatory
processes required with the alternative routes to > Critically evaluate the methodology and conduct of clinical research
demonstrate regulatory compliance.
> Appraise the factors that influence the quality of clinical evaluation
CONTENT
The module provides an overview of the > Demonstrate a systematic understanding and critical awareness of
clinical research paradigm for medical devices the regulatory requirements, directives and associated documentation
and the key underlying ethical and statistical relating to the clinical evaluation of medical devices.
methodology; core regulatory requirements
that relate to the appropriate performance of SKILLS AND ATTRIBUTES
devices; analysis of the place clinical evaluation
plays in risk analysis and risk management Successful students will typically:
during device development and manufacture; > Demonstrate the ability to critically analyse the legal documentation
an understanding of the requirements for relating to clinical evaluation of devices
ethics committee approval and institutional
review board (IRB) approval; knowledge of > Deal with complex issues both systematically and creatively, make
notification and pre-approval requirements; sound judgements in the absence of complete data, and
systematic review in clinical investigation; communicate their conclusions clearly to non-specialist audiences
an understanding of the health technology
appraisal systems and reimbursement on > Critically appraise and evaluate communications from regulatory
clinical evaluation. bodies and stakeholders relating to the conduct of clinical research.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 37MODULE 16 LEARNING OUTCOMES
POST MARKET SURVEILLANCE KNOWLEDGE AND UNDERSTANDING
AND VIGILANCE FOR Successful students will typically:
> Critically evaluate the requirements and guidance for PMS
MEDICAL DEVICES
To enable students to define the terminology > Critically evaluate the requirements and guidance for vigilance
and explain the concepts of vigilance and post
market surveillance (PMS), and their practical > Possess a systematic understanding and critical awareness of
applications and integration into the lifecycle the European requirements including legislation, guidance and
of a medical device. The focus is on meeting associated documentation relating to surveillance and vigilance
European requirements. for medical devices.
CONTENT SKILLS AND ATTRIBUTES
The module covers EU requirements for PMS, Successful students will typically:
including recalls and vigilance, as well as the > Critically appraise a PMS system and make recommendations
role of competent authorities (CAs), notified on the implementation of a PMS system
bodies (NBs), manufacturers and other
economic operators in this area; and relevant > Be able to make recommendations about vigilance procedures
guidance documents. It also includes key
elements of proactive PMS; the role of the > Demonstrate the ability to critically analyse the legal requirements
person responsible for regulatory compliance; relating to surveillance and vigilance
tailoring PMS systems to specific products,
including drug-device combinations and IVDs; > Critically appraise and evaluate communications from competent
and the requirements of EN ISO13485, the authorities, notified bodies, economic operators and other
quality management standard for medical stakeholders relating to the conduct of surveillance and vigilance.
devices.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 39MODULE 17 LEARNING OUTCOMES
REGULATORY STRATEGY IN KNOWLEDGE AND UNDERSTANDING
THE POST MARKET PHASE Successful students will typically:
> Demonstrate a critical understanding of the factors required to
To enable students to provide regulatory affairs maximise the success of a medical device
insight into the strategic issues affecting the
commercial and regulatory maintenance of a > Understand the importance of intellectual property, data protection
medical device throughout its lifecycle, with and product liability and judge when legal advice is required
focus on post-launch activities and future
pressures. > Demonstrate a critical understanding of HTA and reimbursement
CONTENT > Critically evaluate the application of environmental legislation and
This module enables professionals to develop standards to medical devices.
and deepen their understanding of a variety
of topics of importance to the maintenance of SKILLS AND ATTRIBUTES
the commercial and regulatory health of their
company’s medical devices once they have Successful students will typically:
been successfully placed on the market. > Demonstrate the ability to critically analyse the legal, regulatory
Topics include advertising, data protection and quasi-regulatory requirements applying to medical devices
and privacy, patents and IP, health technology
assessment (HTA) and reimbursement, > Deal with complex issues both systematically and creatively, make
environmental legislation and standards, sound judgements in the absence of complete data, and
relationships with distributors, own-branders, communicate their conclusions clearly to specialist and
authorised representatives, trade association non-specialist audiences
and regulatory bodies, product supply and
logistics, product liability law, unannounced > Apply good regulatory practice particularly when interacting with
audits and good regulatory practice. regulatory bodies, including critically appraising communications
> Make recommendations on how to prepare for unannounced audits.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 41MODULE 18 LEARNING OUTCOMES
DRUG-DEVICE COMBINATIONS KNOWLEDGE AND UNDERSTANDING
AND OTHER TECHNOLOGIES Successful students will typically:
> Understand and be able to manage successfully the application
To enable students to consider and evaluate of regulatory requirements and relevant legislation, including
the practical quality and regulatory aspects of required documentation for the purpose of placing medical devices
drug-device combinations and medical devices and drug-device combination products on the market
manufactured by innovative manufacturing
techniques. To explore and critically debate > Critically analyse the further requirements related to innovative
the quality and regulatory issues likely to arise manufacturing processes and recommend strategies for development
from the manufacturing of medical devices with and marketing of medical devices manufactured with innovative/
such techniques, in order to be able provide non-traditional processes
effective management and advice about placing
combination products on the market. > Demonstrate critical understanding of issues related to requirements
dictated by applicable legislation over and above the medical
CONTENT device regulations
Aimed at regulatory professionals interested
or working with medical devices manufactured > Judge appropriate regulatory strategies for drug-device combination
with innovative/non-traditional processes and borderline products.
and/or falling within the classification of
drug-device, combination and/or borderline SKILLS AND ATTRIBUTES
products. It covers: application of legislation,
directives, guidelines; interpretation and Successful students will typically:
classification of documents and regulatory > Demonstrate the ability to interpret, analyse and put into practice
requirements revolving around medical devices current legislation applicable to MDs manufactured with innovative/
manufactured with innovative/non-traditional non-traditional processes
processes, including drug-device, combination
and borderline products. It also includes: PMS, > Make sound judgements of complex issues and deliver strategic
vigilance, notified body/competent authority, solutions and conclusions that can realistically be applied in practice
special requirements for clinical evaluation and
testing, risk analysis and management. > Critically appraise and evaluate communications from regulatory
bodies and research publications regarding medical devices
manufactured with innovative/non-traditional processes.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 43MODULE 19 LEARNING OUTCOMES
REGULATION OF IN VITRO KNOWLEDGE AND UNDERSTANDING
DIAGNOSTICS MEDICAL DEVICES Successful students will typically:
> Demonstrate a critical understanding of the regulatory environment
To ensure that students have a clear in the EU and the legislative framework, and the legislative framework
understanding of the regulatory framework and in other territories and critically evaluate how these compare to the EU
requirements relating to the placing of
in vitro diagnostic medical device products on > Critically evaluate the challenges involved in conducting clinical
the market in the EU with additional reference to evidence studies using IVD products, by considering the differences
regulatory requirements in other jurisdictions. between these products and other medical devices in the design and
production of clinical data
CONTENT
The module covers the current and upcoming > Demonstrate a critical understanding of quality system requirements
regulatory environment in the EU and other
associated with the manufacture and supply of IVDs
jurisdictions, such as Japan, China and Brazil. It
includes: definitions, classification, standards
and conformity assessment; clinical evaluation > Demonstrate a critical understanding of the different stakeholder
and notified body involvement; quality roles involved in manufacturing, supply and regulation of IVDs.
management systems; technical documentation
and requirements for performance data; risk SKILLS AND ATTRIBUTES
management; labelling and product information; Successful students will typically:
traceability, post-market surveillance and vigilance; > Be able to recommend development strategies for IVD products to
registration requirements; and other relevant meet global requirements
legislation. Strategic issues and developing
technologies are also considered. > Explain the regulatory requirements for vigilance and post-market
surveillance for IVDs and be able to make recommendations about
the implementation of a surveillance strategy
> Explain the regulatory requirements for the development of an IVD
medical device and be able to guide the preparation of the IVD
technical documentation needed for CE marking
> Critically appraise and evaluate communications from regulatory
bodies and research publications regarding IVDs.
MSc REGULATORY AFFAIRS | www.topra.org/newmsc MSc REGULATORY AFFAIRS | www.topra.org/newmsc 45You can also read
