Training courses

Training courses
Spring 2010
TFS Academy is founded on knowledge and wisdom
”Science
is organised
knowledge.
TFS Academy
has arranged courses
and
educational
for life.”
clinical trials for many
Wisdom
is programmes
organised
years. What started as internal education activities
– Immanuel Kant
at TFS Trial Form Support, the leading consultancy
company within clinical contract research in the
Nordic region, soon became a much sought after
commodity by our customers.
TFS Academy offers a wide range of qualitative
courses for clinical trial professionals since 2002.
As a consequence of TFS Trial Form Support’s expansion and in response to increasing requests for
training from our clients, the number of different
courses and locations has increased significantly
and TFS Academy now offers more than 20 different open courses in Scandinavia, Spain, Finland,
Denmark and the Netherlands. TFS Academy has
even offered tailored courses for clients in a number of countries outside these countries.
Today our courses are directed towards everyone
who needs to develop their understanding and
skills about clinical trials, e.g. employees of pharmaceutical and biotechnical companies, personnel
at investigator sites and others active within support functions for clinical trials.
The courses deal not only with clinical trials of
pharmaceuticals, but also clinical trials of medical
technical devices.
Clinical trials are controlled by a comprehensive
set of rules and regulations which are constantly
changing and it is therefore very important for
anyone working in this sector to keep updated as
to new requirements and recommendations.
We hope that you will find a course that meets
your training needs and look forward to meeting
you on one of the courses. In the event that we
do not offer the course that you where looking for
please do not hesitate to contact us as we might
be able to provide the course anyway.
How can our courses benefit you?
• Courses are held at many different locations in
order to reduce travel costs
• Course leaders have many years experience of
delivering education and clinical trial activities
• Opportunity to meet colleagues from other companies in the region and to exchange experiences
with them
• Cost and time effective
• Limited number of participants providing an
opportunity for good interaction and a rewarding
training course
Please feel free to apply to one or more of the
courses included in this brochure, by going to our
home page – www.tfsacademy.com or contacting
us directly.
If you need further information about any of
our services please contact:
Sheelagh Corcoran
Global Training Manager
TFS Trial Form Support International
Phone: +46 (0)46 280 19 62
E-mail: [email protected]
Marita Höstberg
Quality Assurance and Training Associate
TFS Trial Form Support International
Phone: +46 (0)46 280 19 61
E-mail: [email protected]
If you are interested in our courses, please
go to our home page www.tfsacademy.com.
Select the appropriate course in the calendar
on the right hand side and follow the instructions to apply for the course.
We hope that you will find something that
meets your educational needs and look
forward to seeing you at one of our training
courses.
Customised courses!
Please see page 5 for further
information!
___________________________
Special offer for companies:
- sending 3 or more participants to a course
- sending participant(s) to more than one
course
Please contact:
[email protected]
for details
_______________________________
Participants receive formal
certificate from TFS Academy!
____________________________
Regional Training Champions
in three regions
____________________________
Training courses
Spring 2010
Training courses
Autumn 2010
• Application to Ethics Committee
• Audits and Inspections
Good Clinical Practice.....................................7
• 2 March, Berghem*
• 10 March Stockholm
• 29 April, Lund*
• Biostatistics, advanced
• Biostatistics for non statistician
• Clinical Research Associate (CRA)
- Introductory Course for CRA
Good Clinical Practice for Investigators
and other research personnel..........................4
•Date and place as requested
• Clinical Study Protocol Writing
• Clinical Study Report Writing
• Contracts and Agreements
Monitoring - 2 days........................................8
• 4-5 May, Madrid*
• 25-26 May, Barcelona*
• 1-2 June, Berghem*
• CRF-design and Data Management
•Effective Site Management
•EU Directives
• Good Clinical Practice • Good Clinical Practice for Investigators and
Monitoring, advanced.....................................9
• 27 April, Barcelona*
• 3 June, Berghem*
Clinical Study Protocol Writing.......................12
• 25 March, Lund
• 20 April, Barcelona *
other research personnel (Date and place as requested. The course will be
held in local language and/or English)
• Introduction to Clinical Research
• Medical Devices
•Medical and Scientific Writing
EU Directives...............................................22
•13 April, Barcelona*
•27 April, Lund*
•20 May, Stockholm
• Monitoring
• Monitoring, advanced
• Patient Information
• Pharmacovigilance, basic
• Project Management for Clinical Research
Tailor made courses.......................................5
• Regulatory Affairs, basic
2
Training courses
Spring 2010
Training courses
Spring 2010
Application to Ethics Committee.....................10
•14 April, Lund
Project Management for Clinical Research
- 2 days.....................................................16
•17-18 March, Barcelona* •21-22 April, Lund* Patient Information.......................................13
• 19 May, Lund*
Clinical Study Report Writing..........................18
•4 February, Lund
•21 April, Barcelona*
Audits and Inspections..................................15
• 3 March, Berghem*
• 23 March, Lund*
• 25 March, Stockholm
Data Management for non-Data Managers
(incl CRF-design)..........................................20
•17 March, Stockholm
•8 April, Barcelona*
• 6 May, Lund*
Medical Devices............................................23
•4 March, Lund *
•23 March, Stockholm
•24 March, Espoo*
Biostatistics for non-statistician......................14
•11 March, Lund Effective Site Management
- 2 days ........................................................6
•9-10 March, Espoo*
•30-31 March, Berghem*
•14-15 April, Stockholm*
•5-6 May, Barcelona*
Biostatistics, advanced..................................21
•18 May, Lund Pharmacovigilance, basic...............................19
•24 March, Stockholm
•4 May, Lund*
•19 May, Barcelona*
Medical and Scientific Writing.........................24
•16 March, Lund
•26 April, Espoo*
* the course will be held in English
3
GCP for Investigators and
other research personnel
Date/location
As requested by customer or at TFS T
­ rial ­
Form S
­ upport office.
Reviewed and approved by IPULS
Language
Swedish or English, as agreed with customer.
Investigators are required to have documented knowledge of ICH GCP guidelines.
This course is normally a one day course but
the duration and content can be customised
to meet client’s needs or requirements.
Cost
To be decided.
For more information please contact us!
Description
•History of GCP
•Declaration of Helsinki
•Principles of GCP
•Ethics Committee
•Investigator’s responsibilities
•Sponsor’s responsibilities
•Safety reporting (AE, SAE, SUSAR)
•Informed Consent
•Protocol and Amendments
•Investigator’s Brochure
•Essential documents
Sheelagh Corcoran
Global Training Manager
Phone: +46 46 280 19 62
E-mail: [email protected]
Target group
Investigators and other research personnel
working with clinical trials in hospital.
4
Tailor-made courses
GCP for Investigators and study nurses is very
popular as is Statistics, Effective Site
Management, Project Management etc.
- Are your staff/investigators adequately
trained as required by ICH E6 GCP
Guidelines?
Special prices for courses requested by
Investigator site staff.
Ask us for details!
- Do you have the time, experience and
trainers to deliver a full range of internal
training programs?
TFS has!!
The choice is yours!
TFS Academy has been providing customised
training for our clients since 2002 and have
the experience, knowledge and trainers to
provide an extensive range of tailor-made
courses for clinical research professionals, both
for Sponsors and Hospital staff.
Contact for further discussion:
Alistair Bone
Director Global Quaity Assurance
E-mail: [email protected]
Phone: +46 (0)46 280 19 60
You have the problem and we can
help you solve it!
You can choose any of our courses and we will
adopt them to your specific needs and
requirements.
The subject for the courses could be:
- GCP
- Monitoring advanced
- Biostatistics
- Project Management
We can provide all the courses in this
catalogue and other courses as stand alone
training.
5
Effective Site Management
Contents:
• Communication
- Exercises to make pitfalls visible
- Tools and techniques
- Result-oriented communication model, how to
ask questions, giving feedback and act
assertive
• Introduction to motivation
- Herzberg case
- Introduction on the Porter theory
- Exercises
• Negotiation
- Introduction to the Harvard method
- Negotiation exercises
• Introduction on how to manage (the site) and
leadership styles
- Leadership style test
- Exercises
- Flexibility test
- 2 days
It is not a simple job for Clinical Research
Associates (CRA) to monitor and manage
investigational sites. CRA’s need - besides
“technical knowledge” - to have special skills,
which they can use to manage the site in
order to ensure that the site staff do things
that have to be done.
This 2-days course has been set up to
develop these skills.
Description
Topics:
• Communication with investigators
• Motivation and behaviour
• Negotiation and how to prevent misunderstandings and conflicts
• Leadership styles
Target group
Clinical Research Associates and Clinical Research
Managers.
Objectives:
• To be able to recognize communication
pitfalls for yourself and others:
- To be able to use a result-oriented communication model
• Insight in the motivation process;
- Insight in your own strengths and weaknesses
• Insight in negotiation and in how to handle
conflicts
• Make participants aware that there are
more leadership styles, than your own
preferred style;
- To be able to leave your own style, if this
style should not be effective
Number of participants
The number of participants for this course is
limited to 14.
Cost
The cost for the course is EURO 925 + VAT when
applying one month prior to the date of the
course. An application after that date costs EURO
950 + VAT. The price includes morning and
afternoon coffee as well as lunch.
6
Good Clinical Practice
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
The aim of this course is to provide a practical introduction to GCP as described in the
ICH E6 guideline and EU Directives. Participants will learn about the ethical issues,
requirements for subject safety and the roles
and responsibilities of those working in clinical research.
This one-day course could be combined
with a web-based examination. For further
information please contact the Training
Department at TFS Trial Form Support.
Description
•History of GCP
•Declaration of Helsinki
•Principles of GCP
•Ethics Committee
•Investigator’s responsibilities
•Sponsor’s responsibilities
•Safety reporting (AE , SAE , SUSAR )
•Informed Consent
•Protocol and Amendments
•Investigator’s Brochure
•Essential documents
Target group
Individuals who have recently started working in clinical research, either in the pharmaceutical industry or as investigational
site staff or those who would like “a refreshment”.
7
Monitoring
- 2 days
The aim of this course is to provide training on how to monitor in compliance with
the principles of GCP. Each type of monitoring visit will be discussed in detail so that
participants can learn how to manage sites
and deal with issues that may arise during
monitoring.
Description
•Monitor’s role
•Investigator’s role
•Site selection visit
•Site initiation visit
•Routine monitoring visit
•CRF and data review
•Investigational Product handling
•End of study visit
•Reporting
Cost
The cost for the course is EURO 750 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 800 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
Target group
Newly appointed monitors and clinicians who
have recently started working in the pharmaceutical industry.
8
Monitoring, advanced
The aim of the course is to provide participants with deeper insight in monitoring and
common monitoring issues.
Description
•Team work
•Site Management
•Investigator meeting
•Monitoring issues
•Data quality and fraud
•Tracking tool
•Time Management
Target group
Monitors with at least 1 year working
experience.
Number of participants
The number of participants for this course is
limited to 15.
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
9
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
Application to Ethics
Committee
The EU directive 2001/20/EC has resulted
in a harmonised and simplier
application process within the EU. To clarify
and fascilitate the interpretation of the
requirements the EU commission has published a guidance document.
The course will look at the guidance document together with national requirements
to give participants a better understanding
of how to apply to Ethics Committees.
Description
• EudraCT form
•Application form
•Application process
•Attachments
•Practical aspects
•Document and attachment
•Contact with Ethics Committees
•EU guidelines
Target group
Persons who want to have better insight in
the application process.
This course is country specific.
10
Introduction to Clinical
Research
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
The aim of the course is to provide participants with an overall picture of the clinical
study process so that they are better prepared for working in the clinical research
environment.
Description
•Background to clinical trials
•Clinical trial phases I-IV
•Legislations and regulations
•Basic GCP elements
•Study design
•Key documents
Target group
All who have recently started working (in
clinical research), either in the pharmaceutical industry or as investigational site staff.
11
Clinical Study Protocol Writing
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
The aim of the course is to introduce participants in how to write a clinical study protocol
including study synopsis.
Description
•Clinical plan, product development
•Study design
•Laws, rules and guidelines
•Content according to ICH guidelines
•Objectives, patient population
•Investigational medicinal product
•Registration of efficacy/safety
•Cooperation with data management/
biostatistics
•Quality control and quality assurance
Target group
The course is designed for anybody who is
planning to or already has started to writeClinical Study Protocols. The course will also
benefit anybody involved in the review of
Clinical Study Protocols e.g. Project
Managers, Clinical Research Managers,
Monitors, Investigators and other site personnel.
Number of participants
The number of participants for this course is
limited to 12.
12
Patient Information
The aim of the course is to provide participants with a better understanding of how to
produce ”Patient Information and Informed
Consent Form” that comply with ethical and
regulatory requirements.
Description
•Laws, rules and guidelines
•Ethics Committee
•Genetic samples
•Content
•Data protection act
•Informed Consent
•Signatures
•Version control and changes
•Practical exercises
Target group
Professionals who need a better understanding of the ”Patient Information and Informed
Consent” process.
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
13
Biostatistics for nonstatisticians
The aim of the course is to give participants
a better understanding of the statistical
issues in the design and analysis of clinical
trials with the purpose of making their
interaction with study statisticians more
effective.
Description
• Basic concept of statistics
• Estimation and hypothesis testing
• Statistical principles for design of clinical
trials
• Measuring effect and effect size
• Sample size calculation
• Protocol deviations, missing data and other
special issues
• Discussion examples
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
Target group
Physicians and paramedical personnel
engaged in conducting clinical trials, who cooperate with statisticians in their daily work
and who want to get a basic understanding
of the role of statistics as applied to clinical
trials.
Participants are expected to have some experience of clinical trials and preferably also
some basic statistical training.
Number of participants
The number of participants for this course is
limited to 15.
14
Audits and Inspections
Number of participants
The number of participants for this course is
limited to 18.
The EU Directive requires that each member
country has its own inspection programme
with its own inspectors.
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
ICH GCP guidelines require that Sponsors/
CROs have their own quality system with
audit programmes. Thus, audits and inspections are an integrated part of work with
clinical trials.
The aim of this training course is to provide
participants with an increased understanding
of what it means to be audited and inspected.
Furthermore, the course will provide an increased understanding of what can be done
to prepare for an audit or inspection and how
one should respond to an audit report.
Description
•What is an audit?
•What is an inspection?
•Regulations
•Preparing for an audit/inspection
•Following up an audit/inspection
•Common findings during audits and inspections
Target group
Clinical Research Professionals who want a
better understanding of audits/inspections.
Recommended for Clinical Research
Associates and Project Leaders.
15
Project Management for
Clinical Research - 2-days
This course provides participants with an
understanding of the principles of project
management. Participants will learn how
to apply project management principles to
clinical research projects and will receive
training in the use of project management
tools designed for clinical research.
Description
•Five basic project management functions
•Five elements of project planning
•Workload planning and management
•Budget planning and management
•Project management tools
•Problem solving
•Time management
•Leadership
•Teamwork
Target group
Newly appointed project managers, experienced monitors wishing to understand
the principles of project management and
medical staff who have recently joined the
pharmaceutical industry.
Cost
The cost for the course is EURO 1 100 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 1 300 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
Number of participants
The number of participants for this course is
limited to 14.
16
xxxxxxxxxxxxxxxxxxxx
Contracts and Agreements
The
aim
the course is to provide
Syfte
ochofmål
participants
knowledge
about
Nytt avtal om with
kliniska
prövningar
underthe
arbete
agreements
in
clinical
trials
and
EU
och nya EU-regler på gång - hur kommer det att
directives.
påverka oss?
16
Description
Målgrupp
•Aim of contracts and agreements
Kursen vänder sig till personer, som i sitt arbete
•Rules and laws
ökadof
kunskap
om och förståelse för hur
behöver
•Principles
agreements
man
upprättar
avtal
och
kontrakt i view
sitt arbete
• Investigator’s and Principal’s
on med
kliniska
prövningar.
agreements between sponsor and investigator/study site
Innehåll
- Content of agreement with the investigator med avtal och kontrakt
•Syftet
- Compensation
•Regler
och lagar to the investigator
••Principer
Principalför
agreements
avtal
•Prövaren
- Additional
och agreements
huvudmannens syn på avtal i
- Administrative costs
kliniska prövningar
•Payment
16
•Avtal mellan sponsor och prövare/klinik
2007 i Lund, kl. 10.00–17.00.
- Vad ska ingå i ett kontrakt med prövare?
Cost
Kostnad
The
cost for the course is EURO 375 + VAT
when
applying
one month
prior to
date
Kostnad
för utbildningen
är 3 500 kr
+ the
moms
vid
of
the
course.
An
application
after
that
date
anmälan 1 månad före kursdagen. Anmälan efter
costs
EURO kostar
400 +3 VAT.
The
price includes
det datumet
800 kr
+ moms.
I priset
morning
and
afternoon
coffee
as well
as
ingår för- och eftermiddagskaffe samt
lunch.
lunch.
Target group
- who
Möjliga
ersättningar
prövare and underAll
needs
further till
knowledge
standing
•Huvudmannaavtal
of how to establish contracts and
agreements
- Sidoavtal, in
nollavtal
clinical trials.
- Administrativa kostnader
This
•Betalningssätt
course is country specific.
Föreläsare
Per Lundström, jurist och ekonom på Öhman &
Partners Ekonomi och Juridik, Stockholm.
Datum/ort
17
Clinical Study Report Writing
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
The aim of the course is to teach participants
how to write clinical study reports including
synopses and appendices in such a way that
they fulfil the regulatory requirements.
Description
The course includes a comprehensive survey
of ICH E3 with tips on how to avoid the most
common problems, how to simplify the writing
process and how to structure quality control
and review. The course will also briefly discuss
when a complete clinical study report is not
necessary and what to include in a report
written under such circumstances.
•ICH E3
•Data presentation
•Quality control & review
•Preparation of appendices
•“Abbreviated clinical study reports”
Target group
The course is designed for anybody who is
planning to or already has started to write
clinical study reports. The course will also
benefit anybody involved in review and
quality control of clinical study reports and
other medical documents. The course will
be of most value to those who already have
some experience in clinical development.
Number of participants
The number of participants for this course is
limited to 10.
18
Pharmacovigilance, basic
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
The aim of the course is to provide participants with a basic understanding of pharmacovigilance and the rules and guidelines
regulating safety reporting.
Description
• Background
•Definitions
•Laws and regulations in clinical trials
• Sponsor’s responsibility
•Laws and regulations post-markering
• MAH’s responsibility
Target group
People needing a basic knowledge of
pharmacovigilance, such as Safety
Assistants, Clinical Research Managers,
Project Managers and Monitors.
Number of participants
The number of participants for this course is
limited to 20.
19
Data Management for nonData Managers (including
CRF-design)
The aim of the course is to provide participants with a basic understanding of how to
design CRFs and how to handle data.
Description
CRF-design
• The aim of the CRF
•CRF vs Protocol
•CRF vs Medical Record
• Instructions to investigators
•ICH GCP
•Monitoring of CRFs
•Source Document
•Paper vs electronic CRFs
Data Management
•Planning
•Database
•Verification and validation
•Queries
•Clean File/Database lock
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
Target group
Clinical Research Managers, Monitors, Data
Assistants and Data Managers.
20
Biostatistics, advanced
The aim of the course is to provide
participants with an in-depth understanding
of biostatistics.
Description
• Demonstrating efficacy
•Group-sequential studies and other
adaptive designs
•Multiple testing
•Methodology for safety and tolerability
•Dose-reponse and dose-finding
Target group
Biostatisticians, programmers with experiences from clinical research.
Number of participants
The number of participants for this course is
limited to 10.
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
21
EU Directives
Clinical Research conducted in the European
member states is now regulated by a number
of Directives and guidance documents. The
aim of this course is to provide participants
with a clear understanding of the contents
and implications of these documents.
Eudravigilance database
Volyme 4 - Good Manufacturing Practice
Inspection procedures
Content of the Study Master File
Target group
All clinical trial professionals.
Number of participants
The number of participants for this course is
limited to 15.
Description
The following Directives and documents will
be reviewed in depth.
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
• Clinical Trials Directive (2001/20/EC)
The Directives is a legal document,
published in 2001, which sets out how
clinical trials investigating the safety or
efficacy of a medicinal product in humans
must be conducted within the European
Union. This document is the basis for clinical
trial legislation in member states.
• Good Clinical Practice Directive
(2005/28/EC)
Lays down the principles and detailed
guidelines for good clinical practice as
regards investigational medicinal products
for human use, as well as the requirements
for authorisation of the manufacturing or
importation of such products.
• Guidance documents applying to
-
clinical trials:
- Application to competent authorities
- Application to ethics committees
- Eudract database
- Collection of Adverse Reactions reports
22
Medical Devices
The aim of this course is to give participants
a basic knowledge of the rules and laws
regulating the development of Medical
Device focusing on how and when to do
Clinical Investigation.
Description
• General
- MDD - Medical Device Directive
- National requirements
- Notified Bodies
- Reporting - requirements
•Country specific experience of working in:
- Europe (different countries within EU)
- USA
•Registration of a product
- CE-labeling (Europe)
- 510k/PMA (USA)
- Classification of a product
- Risk analysis
- Instructions for use and labelling
•Clinical Investigations when, where and
why
- When to do a Clinical Investigation
- Differences between Europe and US
- Ethical Aspects
- ISO 14155 -1 and 2
- Clinical Evaluation
•Group work and presentations
personnel at hospitals or private clinics and
Marketing (how to use Clinical results).
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
Target group
Those who come in contact with Clinical Investigations with Medical Device both
national and international. Research personnel (Clinical and Pre-Clinical), study
23
Medical and Scientific Writing
Cost
The cost for the course is EURO 375 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 400 + VAT . The price includes
morning and afternoon coffee as well as
lunch.
The aim of this course is to provide tools for
effective and clear scientific writing.
Description
• Structuring sentences
- Basic sentence structure (subject-verb-
object)
•Verbs (active, passive, active linking)
• Punctuation
•Writing clear concise sentences
- Word choice (simple versus complex)
- Repeating key terms
- Verb choice, releasing trapped verbs
- Parallelism
- Avoiding wordiness
•Structuring paragraphs
•Targeting your audience (patients versus
professionals)
•Effective document review: Strategic and
inspectional.
Target group
• Pharmaceutical industry - Clinical
Research professionals
• Health care - doctors and other health
professionals
• Academia - scientists and PhD students
Number of participants
The number of participants for this course is
limited to 10.
24
Clinical Research Associate
(CRA) - Introductory Course
Target group
Post graduates or equivalent who want to
start or have recently started working in
Clinical Research in the pharmaceutical
industry.
The aim of this six-day course is to provide
participants with a clear understanding of
Good Clinical Practice (GCP) and the basic
Regulatory Requirements and practical skills
necessary to be able to start working as a
junior CRA. This course includes a one day
communication with investigational site
module (optional).
Cost
The cost for the course is EURO 2095 + VAT
when applying one month prior to the date
of the course. An application after that date
costs EURO 2195 + VAT. The price includes
morning and afternoon coffee as well as
lunch.
Elements of the course
• Clinical Drug development
• Declaration of Helsinki & ICH GCP
• Study Protocol
• Patient Information and Informed Consent
• The European Clinical Trial Directive
• Study Medication
• Ethics Committee and Competent
Authorities
• CRF Design and Data Management
• Basic Statistical issues
• Monitoring visits including Pre, Inititation,
Monitoring and Close Out visits
• Case Report Form review and Source Data
Verification
• Quality Assurance and Audits
• Fraud and Misconduct
• Communication with investigational sites
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New
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COURSE LEADERS
Ulrika Hägg, MSc, PhD, Medical Writer,
Padus AB, Gothenburg, Sweden
Alistair Bone, Director Global Quality
Assurance, TFS Trial Form Support, Lund,
Sweden
starting out as a Medical Writer two years ago, she was a
Alistair has been working with clinical trials since 1989 in
Gothenburg. She has published 11 scientific articles. Ulrika
Ulrika has a PhD in cardiovascular physiology. Before
researcher at the Department of Physiology, University of
a number of different roles. Alistair is currently working as
is a member of the European Medical Writers Association,
Director of Quality Assurance and Training at TFS Trial Form
and currently enrolled in their Professional Development
Support where he has set up and developed the Quality
Programme. She is also a lecturer at the medical faculty in
Assurance and Training department at TFS. He has held nu-
Gothenburg.
merous training sessions in many different areas including
audits, GCP, the European Directive, monitoring etc.
Cecilia Falkenberg, PhD, Team Leader Medical
Writing, TFS Trial Form Support, Lund,
Margareta Svensson, MSc, Team Leader Clinical
Drug Safety Manager, TFS Trial Form Support,
Lund, Sweden
Margareta has a MSc in Pharmacy. She has worked in vari-
Sweden
ous positions at AstraZeneca for many years and she is
Cecilia has been working as a Medical Writer for nearly 5
well-experienced in pharmacovigilance/adverse event
years. Before that she has worked as a researcher in the
reporting. She is today responsible for pharmacovigilance, in
immunology and inflammation research at the medical
post-marketing as well as in clinical studies.
faculty, University of Lund. Cecilia has also been a diligent
lecturer at the County Council and at the University. She
also has a BSc in English.
Annelie Andersson, Project Manager, TFS Trial
Form Support, Gothenburg, Sweden
Annelie has worked in the industry for more than 25 years,
Catherine Heddle, BSc, PhD, Medical Writer,
TFS Trial Form Support, Stockholm, Sweden
8 of these years have been in the Medical Device Industry
(Astra Tech and Mölnlycke Health Care AB). She has also
Catherine is a native english speaker and has a PhD in
been working, studying and living in Canada and has a
Bioschemistry. Catherine has been working as a Medical
Medical background with an experience in Clinical Research
Writer for two years. Before that she worked as a research
working with studies world wide. She has been involved in
scientist at AstraZeneca’s biotechnology laboratory and at
Eucomed CIT (Medical Device, Brussels) and also working
the Department of Oral and Dental Science at the University
with the ISO-14155 1 and 2 on a national level. Annelie
of Bristol.
has been tutoring in a biomaterial course at the University
of Gothenburg of how to perform Clinical Investigations for
Hanna Liedman, PhD, Medical Writer, TFS Trial
Form Support, Lund, Sweden
Medical Device. Since November 2006 Annelie is employed
by TFS Trial Form Support, Sweden as a Project Manager
Hanna has been working as a Medical Writer at TFS for
handling studies both for Medical Device and
nearly 4 years. Hanna has a PhD in immunology from the
Pharmaceuticals.
University of Lund and has previously worked as a
researcher within the fields of immunology and inflammatory diseases, both at the university and in the pharmaceutical
Sheelagh Corcoran, BSc, Global Training Manager, TFS Trial Form Support, United Kingdom
industry. She has also been teaching several courses at the
Sheelagh has worked in the pharmaceutical industry for
university.
nearly 30 years - in many roles including data management
and as a CRA. Her main experience is in training, and she
international study manager in both France and the UK as a
has trained both industry staff and investigators. She has
member of multinational teams in several therapeutic areas.
taught widely throughout the EU and Eastern Europe, and
He also has experience in continuous process improvement,
also in the USA and Japan.
writing and reviewing SOPs and international clinical
operations. Marc is fluent in French and has a diploma in
medical statistics awarded by the University of Paris.
Susan Suchdev, Associate Director Clinical
Operations, TFS Trial Form Support, Stockholm,
Sweden
CRM within the pharmaceutical industry since 1997. She has
Theo van Delft, Quality Assurance
Manager and Advisor, TFS Trial Form
Support, Berghem, the Netherlands
a constant ambition for improvements. Susan has a MSc in
Theo has been working with clinical trials since 1998, first
Nutrition at Karolinska Institute.
as a Quality Officer and later in a number of different
Susan has been working with clinical trials as a CRA and
roles (such as Manager QA, Manager Clinical Research and
Bernhard Huitfeldt, PhD, Statistician,
BH Statistik-konsult, Nykvarn, Sweden
interim, Trainer, Project Manager and Consultant).Before
Bernhard has earlier worked as senior lecturer at the
manager, project manager and scientific researcher in dif-
Statistics Department of Uppsala University. He has for over 30
ferent organisations and sectors.
that (since 1984) he was working as consultant and trainer,
years worked in different statistical roles at AstraZeneca and Phar-
Petra Matthijsse, Clinical Research
Manager, TFS Trial Form Support, Berghem,
the Netherlands
macia, most recently as Global Skills Leader
Biostatistics at AstraZeneca.
Petra has been working within Clinical Research for more
Per Lundström, Legal expert and economist,
Öhman Partners Ekonomi och Juridik,
Stockholm, Sweden
and CRO companies in the role of CRA, CRM and trainer.
Per is one of Sweden’s “most famous persons” in contracts
Today she is responsible for coaching the TFS CRA-group in
and agreements in clinical trials. He has been working with
the Netherlands.
than 19 years. She has worked for several Pharmaceutical
internal and external training for staff in the pharmaceutical
Mette Ravn, Director Global Biometrics,
TFS Trial Form Support, Lund, Sweden
industry and country councils since the beginning of 1990.
He has long experience of commercial and business laws
working with different types of agreements in the
Mette has been working in the Pharmaceutical/Biotech
pharmaceutical area.
Industry since 1988 in a number of different roles within
Biometrics. Mette is currently working as Director Global
Biometrics since June 2009 at TFS and is overall responsible
Marc Surtees, PhD, Quality Assurance Manager and Advisor, TFS Trial Form Support,
United Kingdom
for Statistics, Programming and Data Management globally
in Spain, Sweden and the Netherlands. She has held train-
Marc gained his PhD, in the hormonal control of seasonal
ing sessions in Data Management, use of data management
breeding in 1985. The same year he started to work in the
systems and validation of GXP systems. Mette is currently
pharmaceutical industry. His experience includes 3 years in
the President of the Danish Association of Data Managers
preclinical development performing drug assays and phar-
which is cooperating with INCDMA (the International As-
macokinetic analyses. Since 1990 he has worked in clinical
sociation for Data Managers).
development as a study monitor and then as an
29
Contact Information
QA Services
Alistair Bone, Director Global Quality Assurance
TFS Trial Form Support International
Ruben Rausings gata 11 B, 223 55 Lund
Phone: + 46 (0)46 280 19 60
Email: [email protected]
The Quality Assurance Unit is an independent
unit within TFS Trial Form Support (TFS) which
ensures the quality of the work provided by
TFS by maintaining the quality management
system and conducting internal audits to en-
Sheelagh Corcoran
Global Training Manager
TFS Trial Form Support International
Ruben Rausings gata 11 B, 223 55 Lund
Phone: + 46 (0)46 280 19 62
Email: [email protected]
sure that clinical trials are planned, conducted
and reported in compliance with ICH Guidelines, applicable regulatory requirements, the
study protocol and applicable Standard
Operating Procedures (SOPs).
Marita Höstberg, Quality Assurance and Training Associate
TFS Trial Form Support International
Ruben Rausings gata 11 B, 223 55 Lund
Phone: + 46 (0)46 280 19 61
Email: [email protected]
In addition to providing internal Quality Assur-
Theo van Delft, Quality Assurance Manager and Advisor
TFS Trial Form Support International
Burg. van Erpstraat 4, 5351 AW Berghem, The Netherlands
Phone: + 31 (0)412 40 70 70
Email: [email protected]
nies in the development of their own quality
Merce Ferrer, Secretary
TFS Trial Form Support Spain
Consell de Cent, 334-336, 4a planta, 08009 Barcelona, Spain
Phone: + 34 (0)93 185 02 18
Email: [email protected]
You can also visit our home page:
www.trialformsupport.com
ance for all clinical trials, the Quality Assurance unit also provides flexible, stand alone
services for clients including, conducting
audits and pre-inspections, assisting compamanagement systems, and writing Standard
Operating Procedures.
TFS auditors, who are based in Scandinavia,
the United Kingdom and Benelux countries
have many years clinical research experience and have conducted GCP, GLP and GMP
audits in North America, Asia and throughout
European countries, including Russia and the
Ukraine. TFS Quality Assurance Unit’s main
focus is GCP.
Examples of stand alone services provided by
Clinical Pharmacology Unit audits
the Quality Assurance Unit:
Audits of the unit’s facilities and procedures.
Clinical Quality audits
Pre-Inspections
TFS auditors conduct all types of Phase I to Phase
TFS provide all kind of pre-inspection audits for
IV audits worldwide according to TFS or clients
clients.
standard operating procedures. Audits can be
conducted in compliance with TFS or client’s
standard operating procedures. After the audit
clients are provided with confidential audit reports
and certificates. TFS is also able to assist clients
with Corrective and Preventive Action (CAPA)
process following audits.
Standard Operating Procedures (SOP) writing
TFS Quality Assurance unit can write or update
Standard Operating Procedures (SOPs) according
to client’s specifications. This process can
be conducted together with client staff or
independently. The Quality Assurance unit can also
perform “gap” analysis to identify the need for
revisions to existing SOPs or the need for new SOPs.
Investigator site audits
Single or multi-site audits conducted at any location
worldwide.
Quality Management Support
TFS provide support for clients to develop,
implement or review existing quality management
Document audits
All kinds of document audits, including but not
systems with recommendations for improvement to
limited to:
ensure compliance with regulatory requirements and
guidelines, including:
• Study Master File
• Case Report Form
• Clinical Study Protocol • Clinical Study Report
• Clinical Operations
• Pharmacovigilance
• Biometrics Vendor – sub contractor audits
• Quality Assurance
Audits of all kinds of vendors and sub-contractors,
including CROs to ensure that they meet regulatory
and client requirements and expectations.
Database audits
Audits to ensure the validity and acceptability of the
data in the database.
For further information please contact:
Director Global Quality Assurance
Alistair Bone
E-mail: [email protected]
TFS Trial Form Support Offices
Sweden
The Netherlands
Lund (head quarter)
Ruben Rausings gata 11 B
SE-223 55 Lund
Berghem
Burg. van Erpstraat 4
P.O. Box 1
5351 AA Berghem
Stockholm
Strandbergsgatan 61, 5 tr
SE-112 89 Stockholm
Gothenburg
Drakegatan 7
SE-412 50 Gothenburg
Denmark
Köpenhamn
Vedbaek Strandvej 425
DK-2950 Vedbaek
Finland
Belgium and Germany
(Via The Netherlands)
Spain
Barcelona
Concell de Cent 334-336,
4a planta
ES-08009 Barcelona
Italy and France
(Via Barcelona)
Helsinki
Hevosenkenkä 3
FI-02600 Espoo
Madrid
Arturo Soria 336
7a Planta - Izq
ES-28033 Madrid
Norway
Portugal
Oslo
Hegdehaugsveien 24
NO-0352 Oslo
Lisboa
Rua Quinta dos Loios, 7
Lazarim
2825-156 Caparica
Portugal
United Kingdom
Manchester
Manchester Science Park
Unit 7 Enterprise House
Lloyd Street North
Manchester, M15 6SE
Russia
S:t Petersburg
4/B Sverdlovskaya
Embankment, office 220
Saint Petersburg, 195009
TFS Academy
TFS Trial Form Support International
Ruben Rausings gata 11 B, SE-223 55 Lund
Phone: +46 46 280 18 00, Fax: +46 46 280 18 01
www.tfsacademy.com
India
Ahmedabad
B-32, Tirthbhumi
Apartments
Law Garden, Ahmedabad
380 006
Japan
Tokyo
1-10-3-901, Roppongi, Minatoku
Tokyo 106-0032
USA
Boston (Cambridge)
245 First Street, floor 18
Cambridge,
Massachusetts 02142
Hungary
Budapest
Angyal utca 5
2000 Szentendre
Poland, Czech Republic
(Via Budapest)
Estonia
Tallinn
Kalevi 32-1
10413 Tallin
Latvia and Lithuania
(Via Estonia)