The Final Countdown

(Sorry – Could not resist ;))

Registration officially closes today at 13:00 (1pm, Germany time). There are about 10 tickets left for the conference, so this is your last chance to come and join us next week in Freiburg!
Also, if you are already registered but forgot to book Networking Dinner or Workshops: tickets for these “extras” will also expire today at 1:00 pm.

We may accept a very limited number of registrations beyond today, but really very limited and we can’t guarantee you will get a seat. Therefore, we suggest you don’t wait and grab a ticket now!

Register now before it’s too late >>

See you all next week in Freiburg! The sun is shining here, the Black Forest is taking lovely autumn colors – let’s cross fingers that the weather will be the same during the conference!

MedTranslate Conference: last day to register at the Regular rate!

noch fünf Minuten The MedTranslate is starting in about 2 weeks – and we hope you are as excited as we are!

Remember that today is the last day to register for the conference at the “Regular” price. It will expire this afternoon at 6 o’clock German Time (Central European Summer Time – CEST). From 6:01 on, the “Last-minute” rate wll apply as follows:

- 420 € (+ Eventbrite fee + VAT if applicable) for full conference tickets
240 € (+ Eventbrite fee + VAT if applicable) for one-day tickets

Registration prices for workshops on Friday Workshop Day before the conference and for the Networking Dinner remain unchanged.

And afterwards… there is only a week left to register! Official deadline for registration is September 24th – Wednesday next week. A few late registrations might be accepted beyond this point (depending on the number of tickets left) but only in limited capacity – this is the hotel’s policy so we can’t guarantee you’ll be able to register after September 24th.

What’s in store for you in Freiburg?

Well: top-notch speakers, a highly specialized, no-nonsense conference, end-clients from the medical and pharma industries, agency clients and freelance specialised translators together in a splendid location, a stunning 4 stars-hotel located in the Black Forest with a breathtaking view over the Rhine Valley, the city of Freiburg and the Vosges mountains. But also great food, open-bar dinner, : all the ingredients for a memorable weekend!

What are you waiting for? There are still a few seats left at the conference – register today while the tickets are still in “Regular” pricing and join us in 2 weeks in our gorgeous region!

Looking forward to welcoming you in Freiburg,

The MedTranslate team.

Medical Devices Regulation – a first regulation for medical devices industries

“Medical Devices Regulation – a first regulation for medical devices industries” 
MedTranslate Conference 2014, 3-5 October, Freiburg, Germany
www.medical-translators-conference.com


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Dr. Frank Reininghaus is a chemist (specialized in analytics) and has been working in the medical and pharmaceutical industry for twenty years.

He also participated in courses in business education at the University of Hagen.

He has been working in the software industry for the past 5 years, focusing on medical devices and pharmaceutical companies. During this time, he has also been involved in the approval procedures in the pharmaceutical industry, especially in centralized approval procedures and was the moving spirit for the internal developments regarding PIM at Across Systems.

Since Fall 2012, he’s been focusing on medical devices due to the impact of EU Commission proposals on the regulation of medical devices. He spoke at the tekom main conference about the expected changes in medical devices documentation.

He is also engaged in the field of Change Management and Six Sigma.


Presentation: Medical Devices Regulation – a first regulation for medical devices industries

PIP and its consequences

In April 2010 it was prohibited to sell, market and export any implants from the French company Poly  Implants Prothèses (PIP). The reason was that PIP used industry silicon for its mammal implants and due to this a high number of unforeseen occurrences have been notified.

As reaction of the European Commission a “Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009“ has been published as well as an equivalent regulation on in-vitro diagnostics in September 2012. The idea of the European Commission was to implement a similar institution as the EMA, which is responsible for central approvals of drugs in Europe or the FDA (food and drug administration) in US to prevent any further accidents as PIP and to have a more concrete and direct overview on unforeseen accidents on a central European level.

During the last year these proposals have been discussed between the stakeholders and the different  European Union parties.
On 2 April 2014 the European Parliament formalized their first reading position which is the same as the amendments to the European Commission proposals, which were approved by the European Parliament in October 2013. The Parliament voted in favour of a number of changes to the proposed regulations.
We hope to get a final vote for the regulations end of 2014 or beginning of 2015. This will be followed by a three year transition period leading to a start of the new regulation latest in  2018.

The impact of the regulation on the documentation of medical devices will be shown in this presentation.

Bridging the gap: selling translation services to end-clients – a buyer’s perspective

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“For us working in industrial sectors, choosing a translator or a language service provider is no easy decision. It is part of a company’s strategic move: internationalization. Going into new, unexplored and most of all unknown markets.

The medical field is a very specific one to say the least. Precision and meticulousness are required if we want to succeed and be understood around the world. One vocabulary mistake could potentially lead to the worst consequences.

More than a translation, it is necessary to adapt all documentation to the targeted country and their medical behaviour and customs. Cultural differences are the cornerstone of translation, and need to be thoroughly analysed before entering into a new market. We, as customers, need a real partner to discuss with, and someone who will help us move forward on this road.”

Meet Jean-Baptiste Michon. Jean-Baptiste is Product Owner at ENOVACOM, a French IT company specialized in providing security and interoperability solutions for hospital information systems. Jean-Baptiste is not a translator: he’s an “IT guy” and sales person. In short: he’s a buyer of translation services. An end-client.

And he’s willing – and happy – to meet translators to have an open discussion to exchange on selling translation services to end-clients. And you know what? This is precisely why he will be flying to Freiburg to our upcoming MedTranslate Conference in October. This is a unique opportunity!

See you there…!


Organized by the Alexandria Library and GxP Language Services, the MedTranslate conference 2014 will be held 3-5 October 2014 in the beautiful and historical German city of Freiburg im Breisgau, capital of the Black Forest, at the heart of the “Dreiländereck”, where Germany, France and Switzerland meet.

The conference is aimed at translators specialized or specializing in the medical and pharmaceutical fields and will feature many high-flying and recognized experts, like Matthias Heyn, co-founder of Trados, Ed Zanders, Trainer and CEO of Pharmaguide, Frank Reinighaus, medical devices regulation specialist, or Ronny Stiffel, Branch Manager at Sonovision Germany. There will also be representatives from end-client companies attending and/or speaking: Pfizer, Roche, Medtronic…, along with established and experienced colleagues from the translation industry, like Emma Goldsmith, Marion Alzer, Karen Leube, Pablo Muguerza or Konstantinos Stardelis – to name but just a few – you will find the complete list fo speakers under www.medical-translators-conference.com/speakers

More information: www.medical-translators-conference.com
Programme: www.medical-translators-conference.com/programme

Matthias Heyn – Productivity considerations for the medical translator: a tools perspective

Matthias_Heyn“Productivity considerations for the medical translator: a tools perspective”
MedTranslate Conference 2014, 3-5 october, Freiburg, Germany – www.medical-translators-conference.com

“The pharmaceutical industry is driven by government bodies, by market demand and by good ethical communication practices to supply information in local languages. Local clinical trial documentation, local drug safety information and local product information are mandated by governments. End users expect consistent responses for off-label information in their native tongue. Narratives start in local language feeding into today’s drug safety procedures. European product information alone consists to 96% of text written in a language other than English. Any global pharmaceutical company today coordinates 50+ local language versions of all critical information. And, only a fraction of what would be considered useful in a local context is actually supplied by today’s businesses.
Multilingual (translated) content is increasingly recognized as a key, critical-path elements in both corporate and government organizations when it comes to regulatory, clinical trial, medical information or drug safety procedures.
Today, translation productivity tools (CAT tools) provide a highly sophisticated work environment which makes medical translations more efficient, more reliable and consistent. This presentation will investigate the role of the CAT tools work place, and, specifically their capabilities when it comes to complex labelling translation.”

About the speaker – Matthias Heyn:

Matthias Heyn, M.A. holds a position as VP Global Solutions at SDL International. He specializes in consulting life sciences and public sector organizations to optimize their multilingual business processes. He has worked with major pharmaceutical companies to optimize regulatory translation practices. Matthias Heyn has expertise in global information management, translation production and related technologies. He has worked in his career for SDL in global solutions consultancy, for TRADOS Germany as a software engineer and in business development, he has founded TRADOS in Benelux und TRADOS in Japan. He has worked as lecturer at the University of Heidelberg. He has published in the field of computational lexicology and computational linguistics and in regulatory affairs issues.

Join us in Freiburg at the MedTranslate Conference on Oct. 3-5 to meet Matthias!
More information: www.medical-translators-conference.com
Programme: www.medical-translators-conference.com/programme

 

MedTranslate Speaker spotlight: Ronny Stiffel

MedTranslate 2014, international conference for medical translators, Freiburg im Breisgau, Germany, Oct. 3-5
www. medical-translators-conference.com


Ronny Stiffel

Ronny Stiffel, Branch Manager at Sonovision Deutschland GmbH, Lean Six Sigma Green Belt

After 12 years in the German Naval Air Wing 2, I started my career as a design engineer in the aerospace industry at Airbus in Hamburg. In addition to my main tasks as a design engineer for parts of the Airbus A380, I also started writing Ground Test Requirements for several Airbus aircrafts.

In 2008, I was offered the opportunity  to work as technical author at EADS Military Aircrafts in Manching, Bavaria with a focus on the PA200 Tornado, an aircraft I have been working on for several years now . After an initial training, I took a few courses to improve my writing skills. The most important course in this industrial field was my Simplified Technical English Course in March 2010.

From 2011 to mid-2012, I worked as a project manager for BMW in Munich where I learned a great deal about Lean Management Processes and Six Sigma in several projects. It was BMW that gave me the initial spark to take a Lean Six Sigma Greenbelt course which I completed a year later.

Since mid-2012, I have been the branch manager and general project leader at Sonovision Deutschland in Donauwoerth. We develop several types of technical documentation for our main customer, Airbus Helicopters. Joining us in mid-2013, Merck Millipore became our first customer from the life science industry. We are also developing technical documentation for several products.

In late 2013, I took a Lean Six Sigma Greenbelt course to learn the Six Sigma methods and tools. The objective was to improve our projects with a focus on customer satisfaction, the highest possible quality, and efficiency. Six Sigma in combination with simplified English, standardized documentation and translation have been a success for our projects.


Presentation: 

“The advantages of standardized documentation and translation with the support of Lean Six Sigma and Simplified English”

The highest possible quality in documentation, authoring and translation, is the main focus of our company. In order to achieve highest possible quality in the documentation and translation, it is absolutely necessary to use standards or develop them. The use of standards enables the use of IT-based editing and translation tools.

With the use of standards, the use of quality measurement methods and quality assurance measures is facilitated. This leads to a reduction in production costs and increases the quality of the products.

Six Sigma is a very efficient method for the development of solutions to ensure almost error-free processes. The main objectives of Six Sigma are quality improvement and cost savings.

Every error, made by the company or the employee, has consequences. A customer refuses the work package, a process must be done again and time and/or resources will be wasted. This leads to less efficiency, less productivity and less profit.

Six Sigma describes a process quality which points out only 3.4 errors per 1 million opportunities.

Companies thatuseSix Sigmamethods and toolswill achievelong-term: a continuouscost reduction, revenue growth, improved customer satisfaction andminimizereworkin projects.

Based on mentioned facts and positive examples from companies which have Six Sigma already applied, Sonovision Germany began in late 2013 with the Six Sigma implementation at the site Donauwoerth.

Due to fact that Six Sigma comes from the industrial sector it was necessary for Sonovision to adapt the DMAIC (Define Measure Analyze Improve and Control) project methodology for the authoring and translation business.

Simplified Technical English, or Simplified English is the original name of a controlled language originally developed for aerospace industry maintenance manuals. It is a carefully limited and standardized subset of English. It is now officially known under its trademarked name as Simplified Technical English (STE). STE is regulated for use in the aerospace and defense industries, but other industries have used it as a basis for their own controlled English standards.

Simplified Technical English is claimed to:

  • Reduce ambiguity
  • Improve the clarity of technical writing, especially procedural writing
  • Improve comprehension for people whose first language is not English
  • Make human translation easier, faster and more cost effective
  • Facilitate computer-assisted translation and machine translation

Visit the conference website: www.medical-translators-conference.com
View list of MedTranslate speakers: www.medical-translators-conference.com/speakers

MedTranslate 2014 – International medical & pharma translation conference, Freiburg, Germany

logoWe’re delighted to announce the first MedTranslate conference that we are organizing this year.

It will take place October 3-5, 2014 in Freiburg, in the South of Germany. The event, aimed at international medical and pharma translation professionals, will feature many expert speakers from our industry – such as Emma Goldsmith, Pablo Mugüerza, and many others – as well as speakers from clients’ industries.

Among the excellent speakers and rich programme, Konstantinos Stardelis will discuss the question of rates in medical translation, while Marion Alzer (translator, clinical monitor, phase 1 manager) and Susanne Geercken (Drug safety specialist at Pfizer Germany) will give some keys to find your way in the jungle of pharmaceutical texts. Maarten Milder from Medtronic will discuss Q/A issues, and Ed Zander, author and veteran of the biopharma industry, former research manager at Glaxo, will walk us through the waters of drug discovery and development.

And much more! Check out the line-up of speakers here.

Come and join fellow specialized colleagues for a rich and interesting weekend of learning and networking, in the gorgeous setting of the Panorama Hotel Freiburg and its breathtaking view over the city and the Black Forest!

More information: www.medical-translators-conference.com