Package Insert - mt-g

Transcription

Know-how and information for mt-g customers
No. 29 I March 2013
Package Insert
www.mt‑g.com
Translations for the
Medical and Pharmaceutical Industries
Matrix:
Take the lead through know-how:
Samuel Aubin:
Opt for mt-g
Faster across the line
with the GRA team
Holder of the ASQ
Six Sigma Green Belt
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Page 4
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mt‑g Package Insert
Editorial
15 years on
and highly motivated team of employees. The building is finished and the
vision is reality. Come by and visit us.
the medical information company
We look forward to welcoming you.
The key to success is people. We are
mt-g medical translation is the
leading provider of medical and
pharmaceutical translations,
covering 46 native languages
and 560 language pairs. Stateof-the-art translation technology
ensures efficient processes,
with measurable benefits in
terms of costs and time.
mt-g’s most valuable asset is its
50 project managers and more
than 1,000 highly qualified
native speaking translators and
experts with medical and
linguistic expertise.
very proud of our head of quality management, Samuel Aubin, who has just
received a prestigious award. We also
want to welcome our new members of
staff, all of whom—from project manager to trainee—never cease to impress
us with their respective life stories.
This also applies to the developGerlinde Bendig
ment of Global Regulatory Affairs
around team leader Jessica Weigt; this
We’ve done it! In the next few days the
team processes documents in Ulm for
last workers will be leaving the building
regulatory projects throughout the
site. Our new company building in Ulm
world. In this edition you can also read
will then be completed. 15 years after
the remarkable story of how the team
Worldwide, 75% of the top
100 companies in the medical
and pharmaceutical industries
benefit from mt-g’s translation
expertise.
founding mt-g medical translation a
came into being.
Is your company one of them?
dream has come true for my husband
and me and we can truly say that we
I hope you enjoy this issue.
have accomplished what we set out to
Gerlinde Bendig
do in 1998. This building is a symbol of
Executive Partner
the vision we had of providing the best
mt-g | Values bring people together—
translations for the medical and phar
quality makes the difference
maceutical industries with a proficient
Specialities and teams
 Medical Devices &
Translation Technology
 Global Regulatory Affairs
 Clinical Studies
 Pharmaceutical &
Medical Communication
 Dentistry &
Dental Technology
 Translation &
Localisation Engineering
Contents
Editorial
15 years on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 2
Company news
Aid to decision-making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3
Global Regulatory Affairs team
Pit stop in the regulatory process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
Quality
Six Sigma Green Belt for Samuel Aubin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 5
Meditainment
Pure running talents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6
Social sponsorship
With mt‑g in Querdenkerwald . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6
mt-g was the first European medical
translation services company to achieve
DIN ISO 9001:2008 accreditation.
Company news
Welcome to the team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 8
Page 2

Company
news
Aid to decision-making
Andreas Bendig
Which criteria does a company apply
when choosing a translation service
provider? Are they, for example, only
the hard and directly comparable data
and facts, or do the so-called soft facts
also play a role?
We brought the matter up in personal conversations with a number of
our customers chosen at random. Not
only did the results come as no surprise
to us, but they also confirmed our company philosophy.
Our customers emphasise mt-g’s
combination of high translation competence and professional expertise. As
Europe’s leading translation service
provider for the medical and pharmaceutical industries with more than 15
years’ experience, we are among the
first points of contact for translation
projects. What is the next most important factor? Competence is then followed by quality and respect: the quality
of our service and respect for the people
involved, not only on the client’s side,
but also in our team. I’m personally
Make the direct comparison:
Which service provider will take better care of your sensitive translation projects?
Criteria
Translation
proficiency
15 years’ experience
Carefully selected translators, experienced
native speakers
Professional
expertise
Qualified medical and pharmaceutical
translators
Categorisation into medical subdivisions
Translator selection
procedure
Multi-stage qualification procedure
Continuous assessments
Quality assurance
and certification
DIN EN ISO 9001 certified
DIN EN 15038 registered
Respect and personal impression
Supports social projects, employee-friendly
management
Personal project
manager
At least one permanent project manager for
every customer
Price per word
Depending on language combination, project
type and volume
Minimum charge
Yes / special pricing possible
Proofreading by a
second qualified
translator
On demand, per hour
Project
management
Per hour
Foreign language
typesetting
On demand, per hour or per page
Flexible and on
schedule
Deadlines in close consultation with clients
and translators for fast and realistic delivery
times
Translation memory
systems
Across Language Server
SDL GroupShare/SDL Trados/Studio 2011
Further TMS on request
Translation
memories belong
to the client
As a matter of course
Can be provided as a TMX export whenever
needed
Terminology
management
By arrangement
quite pleased with this. Only then do
customers ask about the price.
We drew up a ranking list for decision factors based on what we had
learned. For all those who value high
quality medical and pharmaceutical
translations, but do not want to lose
sight of the people involved.
mt‑g
Service provider X
mt‑g Package Insert Page 3

Global
Regulatory Affairs team
Pit stop in the regulatory process
The GRA team comprises linguists and business managers (left to right): Corinna Ströbele (PM), Jessica Weigt (PM, team leader), KaiDanielle Angelone (proofreader), Matthias Böhm (proofreader), Sabrina Zimmer (PM); not in the picture: Christoph Buchfelder (PM),
Paul Knauz (PM).
Increasingly often, Formula 1 races
teams were created for the Pharma &
documents pertaining to a drug seeking
are being won off-track. It is the per-
Authorising and Clinical Trials Divisions
approval in several different strengths,
formance of the qualified experts in
to deal with rising order volumes and
often from more than one marketing
the pit lane that decides exactly how
high customer demands. During the
authorisation holder (MAH), need to be
many seconds lead the driver has on
course of further optimisation it soon
translated into 24 languages and may
re-entering the race. This also applies
became clear that the area of regulatory
also require proofreading by a further
to mt-g, where customers can rely on
affairs, in particular, involves a number
qualified translator—this is an optional
the know-how and skill of specialists.
of very specific demands on project
service we offer to clients. Add to this
management. Reason enough for mt-g
the internal quality check that always
With the Global Regulatory Affairs
to specialise even further. The Pharma &
constitutes an integral component of
team, GRA for short, mt‑g not only ful-
Authorising Team was then split into
our quality management. If required,
fils all the given targets when deliver-
two teams: Pharmaceutical & Medical
we can also arrange for the translation
ing translations of the highest quality,
Communication (MedCom for short) and
to be sent to the customer’s branch
but also ensures that efficient work-
Global Regulatory Affairs.
offices abroad. In addition, it may also
flows give companies the edge when
entering the home stretch. Adherence
to schedules, perfect language management and unfailing compliance with
be necessary to copy documents, disInterview
Jessica Weigt, team leader of Global
Regulatory Affairs
international rules are probably the
cuss queries with the translator and
organise a lot of other things besides.
During the critical phase of a project—
the recommendation of approval by the
most valuable prerequisites with which
Ms Weigt, what are the particular chal-
CHMP (opinion on day 210)—things
the team, as a partner for translation
lenges involved in the translation pro-
then often become particularly exciting.
projects, lends its support to the regu-
jects of the GRA team?
The authorities only allow five days for
latory departments of pharmaceutical
companies
and
manufacturers
At mt-g, we deal with projects
submission of the final translation. As
of
requiring the greatest degree of adher-
this deadline usually begins on a Friday
generics, internal translation depart-
ence to official specifications. In addi-
evening, it means that the team and
ments and contract research organisa-
tion to which we usually have extremely
translators work over the weekend pre-
tions (CROs).
high numbers of documents and very
paring the translation, finalising it and
short deadlines. Absolute adherence to
delivering it on time so it can be submit-
Ever since its inception, mt-g has
deadlines is essential in our work.
ted on schedule. We are proud to say
consistently focused on translation pro-
Organising all those involved in a pro-
that so far we have always managed to
jects for the pharmaceutical and medi-
ject into a smoothly functioning unit is
do this. Sometimes we can just perform
cal industries. It was not long before two
particularly challenging. For example,
miracles.
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So, do your team project managers and
translators also have to be qualified to
Quality
Six Sigma Green Belt for Samuel Aubin
perform miracles?
Our capacity for miracles is based
techniques and applications of the
on the special spirit displayed by our
DMAIC model, a structured approach to
project managers and translators, cou-
process improvement. The abbreviation
pled with the readiness to commit to
DMAIC stands for define, measure, ana-
every project with the same degree of
lyse, improve and control. Certified
ardour. We are all exceptionally talent-
Green Belt holders are familiar with the
ed organisers; as experts we give
strategic and economic benefits of Six
painstaking attention to even the
Sigma and bear responsibility for the
smallest of details without losing sight
implementation of complex projects in
of the essential issues. Our translators
their companies. They apply a wide
are all practised in the use of different
spectrum of approaches to the system-
types of templates and display strength
atic improvement of specific processes.
of nerve no matter how critical a situation becomes, even if the tenth update
With this certification, people who
of the update needs to be performed.
How do you convince new customers
of the qualities and performance of
your team?
Personally, I’m in no doubt that
there is no better team for dealing with
regulatory affairs projects. The level of
ability and know-how among our
experts is extraordinarily high and this
have demonstrated profound underSamuel Aubin was born in France in
1976. He studied law and worked as a
project manager at mt-g from 2007 to
2011.
The ‘TÜV-accredited quality specialist’
was appointed as full-time quality
manager at mt-g on 21 June 2011.
Samuel Aubin – Quality Management
qm@mt‑g.com
with outstanding service. We unburden
our clients and lighten their load as
much as we can, so that at the critical
stage of a regulatory process they
receive the best possible support. With
our professional service we speed up
both the development and marketing of
our customers’ products.
ment to quality techniques and practices
receive a formal award, acknowledged
worldwide, for their achievements.
By consistently improving processes, mt-g combines the interests of customers and companies and, in addition
to improving the company’s annual re-
is reflected in the high quality of our
results. This quality goes hand in hand
standing and a high level of commit-
sult, primarily pursues the aim of inThe Certification Board of the
creasing the level of customer satisfac-
American Society for Quality (ASQ) with
tion. When selecting projects, the focus
headquarters in Milwaukee in the USA
is on the sustainable accomplishment
has awarded Samuel Aubin, head of
of customers’ demands and cost con-
quality management at mt‑g, the title
tainment. Quality is an inherent factor in
‘Holder of the ASQ Six Sigma Green Belt
all mt-g processes; a further sign of this
(SSGB)’. In awarding this certificate the
for clients and partners is the successful
ASQ acknowledges that he is in posses-
certification of Samuel Aubin.
sion of all the required skills. In the official press release the ASQ declared,
“Samuel Aubin has achieved a high
level of professionalism in the mastery
and understanding of the Six Sigma
Range of services: Global Regulatory
Affairs team

SmPC
principles and practices.” As a certified
person he is entitled to put the initials
About Six Sigma
‘ASQ SSGB’ on his business card and all
The Six Sigma method for process
improvement was developed by the
Motorola company at the end of the
1980s. It combines specific quality
assurance methods and is used by
numerous companies throughout the
world—not only in manufacturing
industry but also in the services sector.
The Six Sigma method is applied to
successfully minimise process variability
and the errors caused by it.
his professional correspondence.

Labelling

PIL

Application forms

Official correspondence
Belt examinations, candidates must

iscellaneous parts of CTD (nonM
clinical, clinical, administrative etc.)
prove that they have at least three

Company Core Safety Information
methods and processes of quality man-
In order to pass the Six Sigma Green
years’ professional experience with the
agement. Six Sigma encompasses the

Meditainment
Pure running talents
Our runners (left to right): Enrique Guzzetti, Sabrina Zimmer, Michael Schuhmacher, Sabine Heinemann-Brand, Stefan Brand, Barbara
Stroß; back row: Michael Zimmer, Samuel Aubin, Stefan Lopes
Sunshine and 22 °C: ideal running
distances (10 and 5 km). Ulm welcomed
rivers. The Einstein marathon links the
weather! Including for the members of
a total of around 15,000 participants in
Danube cities of Ulm and Neu-Ulm, and
the mt-g staff taking part in the 8th
the various distance categories, includ-
with them the federal states of Baden-
Ulmer Einstein Marathon in September
ing the classical marathon over 42.195
Wuerttemberg and Bavaria. In the team
2012. While Sabrina Zimmer and Michael
km. Due to its well-balanced course
rating, the focus is on promoting com-
Schuhmacher braved and successfully
through parks and urban landscapes,
munal spirit: one team point is awarded
completed the half-marathon (21 km),
this year’s Einstein marathon presented
for every kilometre run, but only for
the rest of the members of the mt‑g
a very special running experience. The
those who manage to cross the finishing
team started as so-called health and
route was very flat because it ran along
line, which the mt-g team members did
recreational runners over the shorter
the banks of the Danube, Iller and Blau
with ease.
sponsorship
Social
With mt‑g in Querdenkerwald
With a donation of 2,500 euros, mt-g is
purchase of many of the young trees,
children planting a new forest in the
supporting the climate protection pro-
including beech, rowan and spruce. In
area appealing. We see it as a good way
ject ‘Querdenkerwald’ (lateral thinker’s
the coming years, the healthy growth of
of interesting young people in climate
forest) on the Internet donor platform
the trees in the ‘corporate forest’ should
protection. As adults they will eventually
betterplace.org.
contribute toward improving the air, as
be able to take a walk through a forest
well as providing safe refuge for many
that they planted themselves”, is how
species of woodland animals.
Gerlinde Bendig explains the motivation
When celebrities from the world of
sport and politics travel to Erkheim on 11
behind mt-g’s sponsorship.
October this year, they had better wear
Wellington boots rather than their usual
leather shoes and high heels.
Thinking out of the box
In 2012, together with actor and
Armed
The aim of the Querdenkerwald
with spades and hoes, and together
project initiators, timber house manu-
almost 100 schoolchildren planted
with numerous local schoolchildren,
facturer Baufritz and the QUERDENKER
around 1,000 saplings. These now form
they will participate in a large-scale
Foundation, is to highlight the impor-
the basis for the Querdenkerwald, which
operation to plant around 1,000 new
tance of climate protection and sustain-
is gradually taking shape on a piece of
saplings in the so-called Querdenker
able interaction with nature. “We
land provided by Baufritz on the out-
wald. The donation by mt-g allowed the
immediately found the idea of school-
skirts of Erkheim. Even at its present
Page 6
environmentalist
Hannes
Jaenicke,
size, the fully grown mixed forest will be
able to store up to 1,800 tonnes of CO2 and
produce 4.6 million kg of oxygen.
Particularly gratifying for all concerned,
including Ottmar Ehrl, founder of the
QUERDENKER Foundation, was the enthusiasm of the many volunteer schoolchildren.
Plans are also afoot to expand the forest
over the next few years.
As corporate partner, mt-g supports a
number of aid projects on betterplace.org.
You can find more information about the
projects at: https://www.betterplace.org/
de/companies/mt‑g
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The aim of Kakuro is to fill in the empty fields using the numbers 1 to 9. These
numbers can only be used once in each row or column. The sum of each row or
column should total that of the clues provided in the black squares. The black
square containing the clue is divided diagonally into two parts. The number in the
top half of the square is the clue for the row, and the number in the bottom half of
the square refers to the column.
The aim of Sudoku is to complete the grid so that each row, column or block of
9 squares contains the numbers 1 to 9, which can only be used once in each case.
The sum of the numbers already placed in the fields is the clue to the solution.
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For every correct solution, mt-g will make a donation to a betterplace project. Send your solution to [email protected]
Your direct contact in our
Sales Department
Company news
Welcome to the team
Diana Becker, 24
Dr Frank Kuhnert
Tel. +49 731 176397-27
frankkuhnert@mt‑g.com

Trainee,
Communication team
Your direct contact to the teams

Vocational
Medical Devices & Translation Technology
medicaltechnology@mt‑g.com
respondent for English and Spanish
Caroline Kaufmann, 24
Clinical Studies
clinicalstudies@mt‑g.com

Project
Pharmaceutical & Medical Communication
medcom@mt‑g.com
Translation & Localisation Engineering
info@mt‑g.com
Quality Management
Samuel Aubin
qm@mt‑g.com
Managing Directors
Gerlinde and Andreas Bendig,
Bernd Mayer
(member of management)
gf@mt‑g.com
baccalaureate and
schooling as foreign language cor‑
Global Regulatory Affairs
gra@mt‑g.com
Dentistry & Dental Technology
dentistry@mt‑g.com
currently assistant in
the Pharmaceutical & Medical
manager in the Medical
Devices & Translation Technology
team
Left to right: Christoph Buchfelder,
Diana Becker, Caroline Kaufmann,
Christian Kämmle

Certified
translator and interpreter
for English specialising in economics,
Diploma of Spanish as a Foreign
Language (DELE), Superior level (C1)
Christoph Buchfelder, 24

Project
manager in the Global
Regulatory Affairs team

Certified
foreign language corre‑
spondent

Certified
translator and interpreter
Christian Kämmle, 30

Sales
coordinator

Business
graduate specialising in
finances and marketing
specialising in technical Spanish
Imprint:
Publisher
mt‑g medical translation GmbH & Co. KG
Stuttgarter Strasse 155, 89075 Ulm
Tel. +49 731 176397-0
Fax +49 731 176397-50
info@mt‑g.com | www.mt‑g.com
Editing
JOLE Kommunikation
Design | Text | PR
PO Box 10 13 15
41545 Kaarst
Tel. +49 2131 314612-0
Fax +49 2131 314612-1
[email protected]
www.jole-kommunikation.com
Cartoon: Evelyn Neuss | Hannover
Layout and typesetting: mt‑g | Ulm
Printing: Druckerei Bittera | Munich
Circulation: 2,800
Feedback: info@mt‑g.com
[email protected]
© 2013
mt‑g medical translation GmbH & Co. KG
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