know-how and information for mt-g customers no. 29 i march ... · package insert know-how and...

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

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


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


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).


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]


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


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 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.


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



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

know-how and information for mt-g customers no. 29 i march ... · package insert know-how and...

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