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Translations for the Medical and Pharmaceutical Industries
Package Insert
Know-how and information for mt-g customers No. 29 I March 2013
Matrix:
Opt for mt-g
Page 3
Take the lead through know-how:
Faster across the line with the GRA team
Page 4
Samuel Aubin:
Holder of the ASQ Six Sigma Green Belt
Page 5
www.mt‑g.com
Page 2 mt‑g Package Insert
Editorial
15 years onmt‑g Package Insert
the medical information company
mt-g medical translation is the leading provider of medical and pharmaceutical translations, covering 46 native languages and 560 language pairs. State-of-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.
Worldwide, 75% of the top 100 companies in the medical and pharmaceutical industries benefit from mt-g’s translation expertise.
Is your company one of them?
Specialities and teams
Medical Devices & Translation Technology
Global Regulatory Affairs Clinical Studies Pharmaceutical &
Medical Communication Dentistry &
Dental Technology Translation &
Localisation Engineering
ContentsEditorial
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
Company news
Welcome to the team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Page 8
mt-g was the first European medical translation services company to achieve DIN ISO 9001:2008 accreditation.
We’ve done it! In the next few days the
last workers will be leaving the building
site. Our new company building in Ulm
will then be completed. 15 years after
founding mt‑g medical translation a
dream has come true for my husband
and me and we can truly say that we
have accomplished what we set out to
do in 1998. This building is a symbol of
the vision we had of providing the best
translations for the medical and phar-
maceutical industries with a proficient
and highly motivated team of employ-
ees. The building is finished and the
vision is reality. Come by and visit us.
We look forward to welcoming you.
The key to success is people. We are
very proud of our head of quality man-
agement, Samuel Aubin, who has just
received a prestigious award. We also
want to welcome our new members of
staff, all of whom—from project man-
ager to trainee—never cease to impress
us with their respective life stories.
This also applies to the develop-
ment of Global Regulatory Affairs
around team leader Jessica Weigt; this
team processes documents in Ulm for
regulatory projects throughout the
world. In this edition you can also read
the remarkable story of how the team
came into being.
I hope you enjoy this issue.
Gerlinde Bendig
Executive Partner
mt‑g | Values bring people together—
quality makes the difference
Gerlinde Bendig
mt‑g Package Insert Page 3
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 per-
sonal 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 com-
pany philosophy.
Our customers emphasise mt‑g’s
combination of high translation compe-
tence and professional expertise. As
Europe’s leading translation service
provider for the medical and pharma-
ceutical industries with more than 15
years’ experience, we are among the
first points of contact for translation
projects. What is the next most impor-
tant factor? Competence is then fol-
lowed 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
quite pleased with this. Only then do
customers ask about the price.
We drew up a ranking list for deci-
sion 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.
Company news
Aid to decision‑making
Andreas Bendig
Make the direct comparison: Which service provider will take better care of your sensitive translation projects?
Criteria Service provider X mt‑g
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 per-sonal 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
Page 4 mt‑g Package Insert
Increasingly often, Formula 1 races
are being won off-track. It is the per-
formance of the qualified experts in
the pit lane that decides exactly how
many seconds lead the driver has on
re-entering the race. This also applies
to mt-g, where customers can rely on
the know-how and skill of specialists.
With the Global Regulatory Affairs
team, GRA for short, mt‑g not only ful-
fils all the given targets when deliver-
ing translations of the highest quality,
but also ensures that efficient work-
flows give companies the edge when
entering the home stretch. Adherence
to schedules, perfect language man-
agement and unfailing compliance with
international rules are probably the
most valuable prerequisites with which
the team, as a partner for translation
projects, lends its support to the regu-
latory departments of pharmaceutical
companies and manufacturers of
generics, internal translation depart-
ments and contract research organisa-
tions (CROs).
Ever since its inception, mt‑g has
consistently focused on translation pro-
jects for the pharmaceutical and medi-
cal industries. It was not long before two
teams were created for the Pharma &
Authorising and Clinical Trials Divisions
to deal with rising order volumes and
high customer demands. During the
course of further optimisation it soon
became clear that the area of regulatory
affairs, in particular, involves a number
of very specific demands on project
management. Reason enough for mt‑g
to specialise even further. The Pharma &
Authorising Team was then split into
two teams: Pharmaceutical & Medical
Communication (MedCom for short) and
Global Regulatory Affairs.
Interview
Jessica Weigt, team leader of Global
Regulatory Affairs
Ms Weigt, what are the particular chal-
lenges involved in the translation pro-
jects of the GRA team?
At mt‑g, we deal with projects
requiring the greatest degree of adher-
ence to official specifications. In addi-
tion to which we usually have extremely
high numbers of documents and very
short deadlines. Absolute adherence to
deadlines is essential in our work.
Organising all those involved in a pro-
ject into a smoothly functioning unit is
particularly challenging. For example,
documents pertaining to a drug seeking
approval in several different strengths,
often from more than one marketing
authorisation holder (MAH), need to be
translated into 24 languages and may
also require proofreading by a further
qualified translator—this is an optional
service we offer to clients. Add to this
the internal quality check that always
constitutes an integral component of
our quality management. If required,
we can also arrange for the translation
to be sent to the customer’s branch
offices abroad. In addition, it may also
be necessary to copy documents, dis-
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
CHMP (opinion on day 210)—things
then often become particularly exciting.
The authorities only allow five days for
submission of the final translation. As
this deadline usually begins on a Friday
evening, it means that the team and
translators work over the weekend pre-
paring the translation, finalising it and
delivering it on time so it can be submit-
ted on schedule. We are proud to say
that so far we have always managed to
do this. Sometimes we can just perform
miracles.
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), Kai-Danielle Angelone (proofreader), Matthias Böhm (proofreader), Sabrina Zimmer (PM); not in the picture: Christoph Buchfelder (PM), Paul Knauz (PM).
mt‑g Package Insert Page 5
Quality
Six Sigma Green Belt for Samuel Aubin
The Certification Board of the
American Society for Quality (ASQ) with
headquarters in Milwaukee in the USA
has awarded Samuel Aubin, head of
quality management at mt‑g, the title
‘Holder of the ASQ Six Sigma Green Belt
(SSGB)’. In awarding this certificate the
ASQ acknowledges that he is in posses-
sion of all the required skills. In the of-
ficial press release the ASQ declared,
“Samuel Aubin has achieved a high
level of professionalism in the mastery
and understanding of the Six Sigma
principles and practices.” As a certified
person he is entitled to put the initials
‘ASQ SSGB’ on his business card and all
his professional correspondence.
In order to pass the Six Sigma Green
Belt examinations, candidates must
prove that they have at least three
years’ professional experience with the
methods and processes of quality man-
agement. Six Sigma encompasses the
techniques and applications of the
DMAIC model, a structured approach to
process improvement. The abbreviation
DMAIC stands for define, measure, ana-
lyse, improve and control. Certified
Green Belt holders are familiar with the
strategic and economic benefits of Six
Sigma and bear responsibility for the
implementation of complex projects in
their companies. They apply a wide
spectrum of approaches to the system-
atic improvement of specific processes.
With this certification, people who
have demonstrated profound under-
standing and a high level of commit-
ment to quality techniques and practices
receive a formal award, acknowledged
worldwide, for their achievements.
By consistently improving process-
es, mt‑g combines the interests of cus-
tomers and companies and, in addition
to improving the company’s annual re-
sult, primarily pursues the aim of in-
creasing the level of customer satisfac-
tion. When selecting projects, the focus
is on the sustainable accomplishment
of customers’ demands and cost con-
tainment. Quality is an inherent factor in
all mt‑g processes; a further sign of this
for clients and partners is the successful
certification of Samuel Aubin.
So, do your team project managers and
translators also have to be qualified to
perform miracles?
Our capacity for miracles is based
on the special spirit displayed by our
project managers and translators, cou-
pled with the readiness to commit to
every project with the same degree of
ardour. We are all exceptionally talent-
ed organisers; as experts we give
painstaking attention to even the
smallest of details without losing sight
of the essential issues. Our translators
are all practised in the use of different
types of templates and display strength
of nerve no matter how critical a situa-
tion becomes, even if the tenth update
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
is reflected in the high quality of our
results. This quality goes hand in hand
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.
Range of services: Global Regulatory Affairs team
SmPC
Labelling
PIL
Application forms
Official correspondence
Miscellaneous parts of CTD (non-clinical, clinical, administrative etc.)
Company Core Safety Information
About Six Sigma
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.
Samuel 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 [email protected]
Page 6 mt‑g Package Insert
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
With a donation of 2,500 euros, mt-g is
supporting the climate protection pro-
ject ‘Querdenkerwald’ (lateral thinker’s
forest) on the Internet donor platform
betterplace.org.
When celebrities from the world of
sport and politics travel to Erkheim on 11
October this year, they had better wear
Wellington boots rather than their usual
leather shoes and high heels. Armed
with spades and hoes, and together
with numerous local schoolchildren,
they will participate in a large-scale
operation to plant around 1,000 new
saplings in the so-called Querdenker-
wald. The donation by mt‑g allowed the
purchase of many of the young trees,
including beech, rowan and spruce. In
the coming years, the healthy growth of
the trees in the ‘corporate forest’ should
contribute toward improving the air, as
well as providing safe refuge for many
species of woodland animals.
Thinking out of the box
The aim of the Querdenkerwald
project initiators, timber house manu-
facturer Baufritz and the QUERDENKER
Foundation, is to highlight the impor-
tance of climate protection and sustain-
able interaction with nature. “We
immediately found the idea of school-
children planting a new forest in the
area appealing. We see it as a good way
of interesting young people in climate
protection. As adults they will eventually
be able to take a walk through a forest
that they planted themselves”, is how
Gerlinde Bendig explains the motivation
behind mt‑g’s sponsorship.
In 2012, together with actor and
environmentalist Hannes Jaenicke,
almost 100 schoolchildren planted
around 1,000 saplings. These now form
the basis for the Querdenkerwald, which
is gradually taking shape on a piece of
land provided by Baufritz on the out-
skirts of Erkheim. Even at its present
Social sponsorship
With mt‑g in Querdenkerwald
Sunshine and 22 °C: ideal running
weather! Including for the members of
the mt‑g staff taking part in the 8th
Ulmer Einstein Marathon in September
2012. While Sabrina Zimmer and Michael
Schuhmacher braved and successfully
completed the half-marathon (21 km),
the rest of the members of the mt‑g
team started as so-called health and
recreational runners over the shorter
distances (10 and 5 km). Ulm welcomed
a total of around 15,000 participants in
the various distance categories, includ-
ing the classical marathon over 42.195
km. Due to its well-balanced course
through parks and urban landscapes,
this year’s Einstein marathon presented
a very special running experience. The
route was very flat because it ran along
the banks of the Danube, Iller and Blau
rivers. The Einstein marathon links the
Danube cities of Ulm and Neu-Ulm, and
with them the federal states of Baden-
Wuerttemberg and Bavaria. In the team
rating, the focus is on promoting com-
munal spirit: one team point is awarded
for every kilometre run, but only for
those who manage to cross the finishing
line, which the mt‑g team members did
with ease.
Meditainment
Pure running talents
mt‑g Package Insert Page 7
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 enthusi-
asm 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
For every correct solution, mt‑g will make a donation to a betterplace project. Send your solution to [email protected]
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the medical information company
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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.
Page 8 mt‑g Package Insert
Imprint:
Publishermt‑g medical translation GmbH & Co. KGStuttgarter Strasse 155, 89075 UlmTel. +49 731 176397‑0 Fax +49 731 176397‑50 info@mt‑g.com | www.mt‑g.com
EditingJOLE KommunikationDesign | Text | PRPO Box 10 13 1541545 KaarstTel. +49 2131 314612‑0 Fax +49 2131 314612‑1mail@jole‑kommunikation.comwww.jole‑kommunikation.com
Cartoon: Evelyn Neuss | Hannover
Layout and typesetting: mt‑g | Ulm
Printing: Druckerei Bittera | Munich
Circulation: 2,800 Feedback: info@mt‑g.commail@jole‑kommunikation.com
© 2013mt‑g medical translation GmbH & Co. KG
Your direct contact in our Sales Department
Dr Frank KuhnertTel. +49 731 176397‑27frankkuhnert@mt‑g.com
Your direct contact to the teams
Medical Devices & Translation Technologymedicaltechnology@mt‑g.com
Global Regulatory Affairsgra@mt‑g.com
Clinical Studiesclinicalstudies@mt‑g.com
Pharmaceutical & Medical Communicationmedcom@mt‑g.com
Dentistry & Dental Technologydentistry@mt‑g.com
Translation & Localisation Engineeringinfo@mt‑g.com
Quality ManagementSamuel Aubinqm@mt‑g.com
Managing DirectorsGerlinde and Andreas Bendig, Bernd Mayer(member of management)gf@mt‑g.com
mt‑g Package Insert
the medical information company
Company news
Welcome to the team
Christoph Buchfelder, 24
Project manager in the Global
Regulatory Affairs team
Certified foreign language corre‑
spondent
Certified translator and interpreter
specialising in technical Spanish
Diana Becker, 24
Trainee, currently assistant in
the Pharmaceutical & Medical
Communication team
Vocational baccalaureate and
schooling as foreign language cor‑
respondent for English and Spanish
Caroline Kaufmann, 24
Project manager in the Medical
Devices & Translation Technology
team
Certified translator and interpreter
for English specialising in economics,
Diploma of Spanish as a Foreign
Language (DELE), Superior level (C1)
Christian Kämmle, 30
Sales coordinator
Business graduate specialising in
finances and marketing
Left to right: Christoph Buchfelder, Diana Becker, Caroline Kaufmann, Christian Kämmle