CAREER DEVELOPMENT FOR
EXPERIENCED REGULATORY
PROFESSIONALS
How TOPRA can support you as you
drive your regulatory career forward
ABOUT TOPRA
TOPRA (The Organisation for Professionals
in Regulatory Affairs) is the professional
association exclusively for individuals
engaged in regulatory affairs and
regulatory science in healthcare.
OUR MISSION
Our aim is to promote the profession and
encourage excellence in its practice.
HOW WE DO THIS
The global TOPRA community includes
members from industry, agency and
support companies, in pharmaceuticals,
medical devices and veterinary medicine,
who can progress through the membership
grades as their career develops.
TOPRA members subscribe to a Statement
of Values which provides an ethical
framework for regulatory professionals.
TOPRA supports its members throughout
their regulatory careers by the provision
of a structured professional development
programme, formal educational
qualifications (including the MSc and
PhD programmes), information resources
including a peer reviewed journal and the
opportunity for informal networking and
independent debate.
CONTENTS
PROGRESSION PATHWAYS2
THE MASTERCLASS PROGRAMME4
GET THE BIGGER PICTURE
7
DEVELOP STRATEGIC LEADERSHIP9
INCREASE YOUR OPERATIONAL EXPERTISE12
TOPRA MSc IN REGULATORY AFFAIRS16
Enabling and promoting excellence in the healthcare regulatory profession
1
PROGRESSION PATHWAYS
As regulatory professionals we are
fortunate to have a wide variety of
career choices. In order to be successful,
regulatory professionals must keep up
to date and continually refine their skills
and knowledge.
TOPRA supports members in doing this
by providing a continuing professional
development (CPD) programme and
encouraging all members to identify their
learning needs and how these might be
addressed; then to meet these needs
by whatever means is most suitable (eg
reading, mentoring, courses) and evaluate
the effectiveness of that learning and
record it as part of their CPD record.
TOPRA offers training courses, conferences
and networking opportunities that help to
provide you with the technical information
and skills development you need at all
stages of your career.
Although every individual career pathway
is different, we have identified five key
‘stages’ that can be applied to any
regulatory career.
E xploring: entrants to the profession
who are investigating regulatory affairs
as a career are at the ‘exploring’ stage –
our Basics courses are ideal for people
starting their careers or considering a
move from a related sector, eg medical
writing.
E stablishing: professionals who have
decided on a regulatory career and
are building a firm foundation in the
fundamentals are at this stage. Our
Foundation courses (such as the
Introductory Courses) are ideal for
this stage.
onsolidating: the stage at which
C
committed regulatory professionals –
typically those having about 2–5 years’
experience – are building expertise in
a specific range of areas or projects.
Our ‘CRED’ programmes are tailored
for their level of experience.
1. EXPLORING
KEY STAGES
IN YOUR
REGULATORY
CAREER
2
• Those wanting to take their first
steps in regulatory affairs
• Those in other disciplines who need
an overview
Up to 6 months’ experience
2. ESTABLISHING
• Those who have recently joined the
profession
• Those whose regulatory experience is
outside the EU
6 months – 2 years’ experience
Driving: supporting those who have
worked in the field for a while and want
to make their mark in the regulatory
profession. They may be taking on
management responsibility, running
a business or becoming an in-house
‘expert’ or even moving into a related
area like HTA/PV. Our Masterclasses
and Horizons courses and conferences,
are developed to meet their needs.
Influencing: these regulatory
professionals have reached the level of
senior directors or vice presidents – often
with Fellowship of TOPRA too. They have
strategic roles and play on the wider
stage, maybe influencing new legislation
through trade bodies and other external
organisations. Our Roundtables and
Fellows’ Dinners, as well as the Annual
Symposia, will give them the opportunity
to look at future developments and
debate the issues.
All TOPRA training and educational courses
and conferences are linked with these
stages, making it even simpler to plan your
own personal development programme –
and to source training for your regulatory
team. Go to topra.org/careers for
more information.
5. INFLUENCING
4. DRIVING
3. CONSOLIDATING
• Experienced professionals
committed to developing their
regulatory and management
competencies
• Those at a senior level taking
on additional responsibilities or
looking to diversify their skills
• Discussion, debate, and
networking opportunities for senior
professionals
8+ years’ experience
5+ years’ experience
2 – 5 years’ experience
This booklet is targeted at experienced professionals who are driving their
career forward. Our programme of Masterclasses is a perfect opportunity for
you to study and keep up-to-date on the crucial aspects of regulatory affairs.
3
THE MASTERCLASS
PROGRAMME
INTRODUCTION
TOPRA has more than 25 years’ experience
in delivering a structured, continuing
development programme of courses,
meetings and seminars to meet the needs
of regulatory professionals at all stages in
their careers.
Our residential Masterclass courses are
designed to meet the educational and
vocational needs of experienced regulatory
professionals in the pharmaceutical and
allied industries.
STRUCTURE OF
EACH MASTERCLASS
Each pharmaceutical Masterclass lasts
2.5 days and is built around lectures, case
studies and discussion groups. Lecturers
are drawn from the industry, regulatory
authorities and academia. Around five
pharmaceutical Masterclasses are held
each year.
Emphasis in most of the courses 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.
4
A total of 12 continuing professional
development Masterclasses are on offer
providing the opportunity for experienced
regulatory professionals to gain valuable
in-depth knowledge and updates. A
summary of the Masterclass programme,
grouped into courses that provide an
overview, those that focus on regulatory
strategy and those that concentrate on
developing operational skills and expertise,
is given below.
OVERVIEWS
The US Regulatory Environment
Medical Device Regulatory Affairs
IN-DEPTH KNOWLEDGE OF
REGULATORY STRATEGY
Strategic Planning in Regulatory Affairs
egulatory Strategy for a New Active
R
Substance: Nonclinical Development
egulatory Strategy for a New Active
R
Substance: Global Clinical Development
Regulatory Strategy: The Market Place
egulatory Strategy for Established
R
Active Substances
OPERATIONAL SKILLS AND EXPERTISE
Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy
Regulatory Control of Clinical Operations
Data Requirements for Abridged Applications and Specialised Products
Registration of Biological, Biotechnology and Advanced Therapy Products
ptimising the Contribution of Regulatory Affairs to Product Development, Maintenance
O
and Commercialisation
MASTERCLASSES IN MEDICAL
TECHNOLOGY REGULATORY AFFAIR
Medical device regulatory professionals have access to their own specialised
Masterclasses to deepen their knowledge and competencies in this highly specialised
area of regulatory affairs. You can take 3-day residential Masterclasses on any or all of the
following topics:
Principles of European Medical Technology Regulatory Affairs
Design, Development and Testing of Medical Technology
Clinical Evaluation of Medical Technology
Management of Regulatory Affairs and its Contribution to the Medical Product Lifecycle
Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management
Regulation of Drug-Device Combinations and Other Medical Technology Products
US Regulation of Medical Technology
Regulatory Strategy in the Market Place
The Masterclasses are part of a collaboration between Cranfield Health and TOPRA.
They comprise part of the TOPRA MSc in Medical Technology Regulatory Affairs
– go to www.topra.org/mscmtra or email [email protected].
5
This programme was a valuable
experience for me and I have already
recommended the course to some of
my colleagues, as I believe it can be
very helpful to their careers
6
GET THE BIGGER PICTURE
THE US REGULATORY
ENVIRONMENT
MEDICAL DEVICE
REGULATORY AFFAIRS
You will have the opportunity to 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.
This is an opportunity for pharmaceutical
regulatory professionals to gain a good
understanding of the regulatory control of
medical devices in the EU. You will be able
to advise on the application of the medical
device directives and how to achieve
CE marking for products.
LEARN HOW TO:
Examine the legal basis of pharmaceutical
regulations in the US and how the FDA
operates within the legal framework
Differentiate the format and content
of IND, NDA, BLA, ANDA and SNDA
submissions, and examine the practical
issues associated with these applications
Analyse FDA approaches to specific
product types such as OTC products and
orphan drugs
Assess the impact of US regulatory
affairs on the global development and
regulatory strategy for pharmaceuticals.
NEXT COURSE: April 2016
You may be interested in our
complementary Masterclasses on
Global Regulatory Strategy; Global
Clinical Development and Regulatory
Strategies for Biotechnology Products.
LEARN HOW TO:
Distinguish the routes to Conformity
Assessment in the EU
Assess the role of the Competent
Authorities and the Notified Bodies
Define the requirements of post-market
surveillance and vigilance, and the role
that risk management plays throughout
the lifecycle of a device
Compare how medical devices are
regulated in other markets and examine
related international activities such as the
Global Harmonisation Task Force
Interpret the requirements of clinical
evaluation, learn how to initiate a clinical
study and understand the ever-increasing
impact of Health Technology Assessment.
NEXT COURSE: November/December 2016
You may be interested in complementary
Masterclasses from the MSc Medical
Technology Regulatory Affairs, see page 5.
7
8
DEVELOP
STRATEGIC LEADERSHIP
STRATEGIC PLANNING IN
REGULATORY AFFAIRS
As you progress through your career, aspects
of project management and strategic
planning become more important. You will
need to develop the ability to anticipate
problems, analyse complex situations,
and offer the optimal strategy in order to
achieve marketing approvals worldwide in
a timely manner. This Masterclass will help
you to consider and appreciate strategic
regulatory aspects of global regulatory
affairs and provide effective advice on the
commercial implications of regulatory affairs
activities involved with approval and pricing
negotiations.
LEARN HOW TO:
Determine the global regulatory strategies
and development programmes required
to achieve marketing authorisation
approval in Europe, North America,
Japan and beyond
Assess and discuss the commercial
implications of regulatory approval and
pricing negotiations
NEXT COURSE: 10–12 December 2014
You may be interested in our
complementary Masterclasses
on Optimising the Contribution
of Regulatory Affairs to Product
Development, Maintenance and
Commercialisation; and Regulatory
Strategies in the Marketplace.
The greatest strength
of the course is the wealth
of experience provided
by the speakers...
The people involved
are very experienced
and enthusiastic
about the profession
Analyse regulatory issues relating
to in- and out-licensing of products
Define the interactions between the
company and regulatory agencies.
9
NONCLINICAL DEVELOPMENT:
NEW ACTIVE SUBSTANCES
GLOBAL CLINICAL DEVELOPMENT:
NEW ACTIVE SUBSTANCES
This Masterclass will provide you with an
understanding of the key requirements and
submissions strategies associated with
the nonclinical development process so
that you can provide effective regulatory
leadership throughout this phase. It will
allow you to explore and understand
nonclinical regulatory aspects for global
drug development. It covers the regulatory
issues likely to arise during nonclinical
programmes.
You will consider regulatory strategic
aspects of global clinical research, as
well as review the global regulatory
issues likely to arise during multinational
clinical trials. This Masterclass will also
help you demonstrate effective regulatory
leadership in your organisation throughout
the clinical development and registration
of a new medicine.
LEARN HOW TO:
Describe the research processes
used to identify and select new
candidate compounds
Analyse the types and designs of
nonclinical safety studies required to
successfully develop a new product
Assess the regulatory acceptability of
nonclinical development programmes
and determine the format and content
as well as submission strategy for
such information
Interpret pharmacokinetic principles
and how these are applied to link the
nonclinical and clinical components of
pharmaceutical development.
NEXT COURSE: 4 – 6 February 2015
You may be interested in our
complementary Masterclasses
on Global Clinical Development;
and Registration of Biotech and
Advanced Therapy Products.
10
LEARN HOW TO:
Differentiate the types of clinical study
design and identify the pros and cons
of each within the context of global
regulatory requirements
Evaluate the medical, statistical,
economic and operational principles
underpinning the successful conduct of a
clinical trial programme
Identify the activities required to
ensure that data suitable for a product
registration are derived from the clinical
studies programme
Determine the strategic role of clinical
study reports and summaries in obtaining
an optimal product label
Understand the regulatory authorities’
views of the clinical dossier.
NEXT COURSE: 3–5 June 2015
You may be interested in our
complementary Masterclass on
Regulatory Control of Clinical
Operations.
REGULATORY STRATEGY IN
THE MARKET PLACE
Investigate the role of regulatory strategy in
commercialising products and maintaining
the brand throughout a product’s lifecycle.
You will explore the regulatory issues likely
to arise during commercialisation so you
can give effective advice.
LEARN HOW TO:
Recognise the needs of marketing
colleagues in commercialising products
and maintaining brand awareness through
the development of new dosage forms,
indications and switching of legal status
Optimise the marketing life of a product
by use of patents and supplementary
protection certificates and demonstrate
how regulatory professionals help
maintain the edge that such protection
might offer
Evaluate the role of regulatory affairs in
optimising regulatory strategy in a manner
that is sympathetic to the needs of pricing
and reimbursement committees, so that
commercial advantages may be gained
Illustrate the importance of the SmPC
as a means of communication with
prescribers and for patient information
Define the responsibilities and
requirements for keeping the licence
current with respect to the reporting of
adverse drug reactions.
NEXT COURSE: November 2015
You may be interested in our
complementary Masterclasses on
Strategic Planning; and Strategies
for Established Active Substances.
REGULATORY STRATEGY
FOR ESTABLISHED ACTIVE
SUBSTANCES
Gain an understanding of the strategic
issues to be addressed in relation to
medicines containing established active
substances, including line extensions,
generics and OTC products. It is an
opportunity to review the regulatory
issues likely to arise for established active
substances.
LEARN HOW TO:
Distinguish between the differing types
of abridged applications possible in the
EU and identify situations when the use
of each of these is appropriate
Design and evaluate strategies for
submissions in EU markets for products
containing established active substances
Compare the routes to approval in the
US for products containing established
active substances, sufficient to provide
regulatory leadership to colleagues in
this market.
NEXT COURSE: March/April 2016
You may be interested in our
complementary Masterclasses on
Data Requirements and Specialised
Products; Registration of Biotech and
Advanced Therapy Products; and the
US Regulatory Environment, which
provides more detail on regulation
of established active substances
in the US.
11
INCREASE YOUR
OPERATIONAL EXPERTISE
NEW CHEMICAL ACTIVE
SUBSTANCES: CHEMISTRY
AND PHARMACY
The focus of this Masterclass is to explore
and understand the regulatory issues likely
to arise during chemistry and pharmacy
data documentation requirements for
drug development. You will develop a
sound understanding of the chemistry and
pharmacy development programme in order
to provide effective advice on the suitability
of the chemistry and pharmacy programmes
from a regulatory perspective.
LEARN HOW TO:
Identify the drug substance requirements:
nomenclature, description, synthesis,
development chemistry, quality control
during synthesis and stability
efine the drug product requirements:
D
formulation and pharmaceutical
development, dissolution testing,
bioequivalence of different dosage
forms used in clinical trials, manufacture,
GMP, process validation, specifications
and routine tests, analytical method
development, packaging and stability
ecognise the importance of
R
analytical validation
12
iscriminate between the chemical and
D
pharmaceutical aspects of clinical trial and
marketing authorisation applications
efine the formatting of the chemistry
D
and pharmacy documentation as
per the requirements of the Common
Technical Document
nderstand the regulatory
U
authorities’ views of the chemistry
and pharmacy dossier.
NEXT COURSE: 15 – 17 April 2015
You may be interested in our
complementary Masterclasses on
Regulatory Strategy for a New Active
Substance; Data Requirements for
Abridged Applications and Specialist
Products; and the US Regulatory
Environment, which covers specific
requirements for New Drug Applications
in the US.
REGULATORY CONTROL
OF CLINICAL OPERATIONS
Gain an understanding of the practical
regulatory aspects of global clinical
research, so you can provide effective
advice on the regulatory issues likely to
arise during clinical programmes.
LEARN HOW TO:
nderstand the practical aspects of GCP
U
and how it supports clinical research
Identify the regulatory requirements
for clinical research in major markets,
understand the importance of the EU
Clinical Trial Directive and how to prepare
clinical trial applications and associated
documentation
onsider the complexities and
C
requirements of pharmacovigilance in
clinical research
nderstand the management of clinical
U
trial supplies and the requirements of
GMP, authorisation and importation of
investigational medicinal products
nderstand clinical trial reporting, the
U
management of the data, data auditing
and the practicalities of GCP inspections.
NEXT COURSE: September 2015
You may be interested in our
complementary Masterclass on
Regulatory Strategy for Global Clinical
Development.
DATA REQUIREMENTS FOR
ABRIDGED APPLICATIONS
AND SPECIALISED PRODUCTS
This Masterclass will help you understand
the diversity of abridged applications,
and the data requirements for a variety of
new dosage forms and new indications –
as well as data requirements for certain
specialised products.
You will have the opportunity to explore
and critically debate the regulatory issues
likely to arise for abridged applications
and specialised products in order to be
able to provide effective advice.
LEARN HOW TO:
Identify the chemical/pharmaceutical,
nonclinical and clinical data required for
line extensions taking into account the
interaction between the various parts
of a dossier
efine the requirements for bridging
D
data in various situations
E xamine the data requirements for line
extensions, generic applications and for
specialised products
Evaluate the data requirements for
Supplemental Applications in the US.
NEXT COURSE: June 2016
You may be interested in our
complementary Masterclass on
Regulatory Strategy for Established
Active Substances.
13
REGISTRATION OF BIOLOGICAL,
BIOTECHNOLOGY AND ADVANCED
THERAPY PRODUCTS
This advanced course will help you get to
grips with regulatory strategy for biological,
biotechnology and advanced therapy
products. It is an opportunity to study
and understand the scientific principles
underpinning development of biological/
biotechnology products and how their
inherent complexities impact on regulation.
LEARN HOW TO:
iscern the differences between a
D
biological and a chemical entity and
recognise and interpret the complex nature
of biological/biotechnology products
You will explore the management
issues likely to arise in running a
successful regulatory department for
product development, maintenance and
commercialisation. Identify the skills you
will need to optimise your department’s
contribution to this process. Collaboration
with other key departments will be
addressed, including an introduction to the
influencing and negotiation skills needed
for effective teamwork.
LEARN HOW TO:
emonstrate a comprehensive
D
understanding of the regulatory
requirements and associated
documentation with the licensing of
biological, biotechnology and advanced
therapy products
E xamine tools such as regulatory
intelligence and IT that are available
to help manage a department
nalyse the implications of change in
A
production process on product and the
concept of comparability
E stablish how regulatory professionals
can maximise their contribution to
product development, maintenance
and commercialisation by collaborating
and negotiating appropriately with
other departments
ritically appraise and evaluate
C
communications from regulatory bodies
and research publications regarding
biological, biotechnology and advanced
therapy products.
NEXT COURSE: February 2017
14
OPTIMISING THE REGULATORY
CONTRIBUTION TO PRODUCT
DEVELOPMENT, MAINTENANCE
AND COMMERCIALISATION
You may be interested in our
complementary Masterclasses
on Global Regulatory Strategy;
Nonclinical Development; New
Active Substances and Regulatory
Control of Clinical Operations.
ategorise the key departments with
C
which regulatory affairs needs to
work cooperatively
E valuate the necessity of project/
portfolio management and
decision analysis.
NEXT COURSE: September 2016
You may be interested in our
complementary Masterclass on
Strategic Planning which includes
the commercial implications
of drug development.
I met many interesting people with whom I am still
in contact. With some of them we even developed
a professional relationship which proved very
valuable for our business
15
ADVANCE YOUR
PROFESSIONAL CAREER
WITH A QUALIFICATION
THE TOPRA MSc
IN REGULATORY AFFAIRS
All Masterclasses can be taken as
part of the TOPRA part-time MSc
in Regulatory Affairs.
The MSc in Regulatory Affairs, offered by
TOPRA and validated by the University
of Hertfordshire, provides a unique
opportunity to study aspects of regulatory
affairs at an advanced level.
The MSc course is designed for regulatory
affairs professionals working in the
pharmaceutical industry. To operate
successfully, regulatory 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.
The course was established in 1989, and
it is designed for professionals working
in regulatory affairs who have already
16
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
regulatory professionals at a relatively early
stage in their regulatory career, or more
experienced people who have perhaps
worked in related industrial functions before
specialising in regulatory affairs.
To obtain the MSc you must take
eight modules and satisfy the other
requirements stated in the schedule of
assessment, including the completion of a
research-based dissertation in five years.
You can enrol for the MSc at any module or
Masterclass course.
TOPRA takes full responsibility for the
operation and management of the course,
which is fully validated by the University of
Hertfordshire.
If you are interested in taking the MSc in
Regulatory Affairs email [email protected]
7FHH1097
Spring/Autumn annually
Overview of EU Regulatory Affairs
7FHH1098
10–12 December 2014
Strategic Planning in Regulatory Affairs
7FHH1099
4–6 February 2015
Regulatory Strategy for a New Active Substance: Preclinical Development
7FHH1100
15–17 April 2015
Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy
7FHH1101
3–5 June 2015
Regulatory Strategy for a New Active Substance: Global Clinical Development
7FHH1102
September 2015
Regulatory Control of Clinical Operations
7FHH1103
November 2015
Regulatory Strategy: The Market Place
7FHH1104
March/April 2016
Regulatory Strategy for Established Active Substances
7FHH1105
June 2016
Data Requirements for Abridged Applications and Specialised Products
7FHH1106
February 2017
Registration of Biological,Biotechnology and Advanced Therapy Products
7FHH1107
September 2016
Optimising the Contribution of Regulatory Affairs to Product Development,
Maintenance and Commercialisation
7FHH1108
April 2016
The US Regulatory Environment
7FHH1109
November/December 2016
Medical Device Regulatory Affairs
7FHH1110
Dissertation
The 13 modules available for students to study as part of the MSc – go to
www.topra.org/mscra for the latest information (dates correct as of October 2014).
17
Bellerive House, 3 Muirfield Crescent, London E14 9SZ
T: +44 (0)20 7510 2560 F: +44 (0)20 7537 2003
E: [email protected] W:www.topra.org
TOPRA – The Organisation for Professionals in Regulatory Affairs Ltd.
Registered in England company number 1400379. A company limited by guarantee