Tag Archives: compliance

And the winner is….

It seems The Stinging Nettle totally honored its name. I was amazed at the number of aggressive, sometimes even insulting comments and e-mails we’ve been receiving since the beginning of this action – it’s just fascinating how many people felt personally attacked. Anyway – here’s the promised result ;)

Whoever works in the medical translation field should be aware of the numerous existing standards (DIN/EN/ISO…) in this industry. Often, these standards even state the exact wording of entire segments. We’ve been so far expecting from translators to be able to identify whether a piece of text is subject to a certain standard (or could be) and accordingly conduct a search or contact us and simply ask. In this specific case, the relevant standards to use were DIN EN 980:2008-08 “Symbols for use in the labeling of medical devices; German version” and the draft standard DIN 6877-1:2007-12 “Magnetic resonance equipment for human use – Part 1: Instructions for labeling items within the controlled area”.

“Keller”, though not specialized in medical device texts, submitted a translation that was the closest in line with the rules of these standards and therefore earns the 50€. “S.W” (who’s no medical translator either) and “AL” did realize that those were texts that were probably set in standards but unfortunately did not submit any proposal.  I found “Michael’s” proposal very interesting as well – he is not a translator but his translation was qualitatively not different from many proposals.

You can read all proposals here and here

What did we learn?

None of the translators who participated knew the standards. Some found them as they were researching and translated correctly but most would probably have made a “wrong” translation of the segments. It occurred to us that during our time as freelancers, no agency ever said to us that a given part of the text was subject to a given standard nor ever provided us with these standard existing translations available (though this does not completely apply for pharmaceutical texts as some agencies take the time and provide their translators with all standards). We came therefore to the decision that, in the future, we will be informing our translators when we give them a new project where standards apply and make those standards available to them.

I would like to thank all translators who participated. It was an interesting experience and we did learn something. We hope that translators in the future will also pay more attention to regulatory requirements in the medical technology field, and keep themselves up-to-date with these as well.
The next “translation survey” is already in the oven and we’d be delighted if you decide to participate again, or participate for the first time!

Und der Gewinner ist…

Die Stinging Nettle scheint ihrem Namen alle Ehre gemacht zu haben.
Ich war erstaunt, wie viele bösartige, ja sogar teilweise beleidigende Kommentare und Mails wir seit Beginn dieser Aktion erhalten haben. Es ist interessant, wer sich alles auf den Schlips getreten fühlte. Aber egal, hier die versprochene Auflösung:

Wer Übersetzungen im Bereich Medizintechnik anfertigt, sollte sich bewusst sein, dass in dieser Industrie viele Standards (DIN/EN/ISO etc.) einzuhalten sind. Diese Standards schreiben oft auch den genauen Wortlaut für bestimmte Segmente vor. Wir hatten bisher von Übersetzern erwartet, dass sie erkennen, ob ein Textteil einem Standard unterliegt/unterliegen könnte, und entweder entsprechend recherchieren oder sich an uns wenden und nachfragen. In diesem speziellen Fall wären das die DIN EN 980:2008-08 “Symbole zur Kennzeichnung von Medizinprodukten; Deutsche Fassung” und der Normentwurf zur DIN 6877-1:2007-12 “Magnetresonanzeinrichtungen für die Anwendung am Menschen – Teil 1: Kennzeichnungsvorschriften für Gegenstände im Kontrollbereich” gewesen.

“Keller”, obwohl er kein auf Medizintechnik spezialisierter Übersetzer ist, hat einen Vorschlag eingestellt, der weitgehend den Vorschriften dieser Normen entspricht und sich damit die 50 Euro verdient. “S.W” (übrigens auch kein medizinischer Übersetzer) und “AL” haben zwar erkannt, dass es sich um Texte handelt, die wahrscheinlich in Standards festgelegt sind, haben aber leider keine kompletten Vorschläge abgegeben. Interessant fand ich auch den Beitrag von “Michael”, der kein Übersetzer ist, aber einen Vorschlag eingestellt hat, der sich qualitativ von vielen anderen Vorschlägen nicht unterscheidet .
(Alle Übersetzungsvorschläge von den Teilnehmern finden Sie hier und hier)

Was konnten wir daraus lernen:

Keiner der Übersetzer, die geantwortet haben, kannte die Standards. Einige hätten die Standards wohl beim Recherchieren gefunden und richtig übersetzt. Die Mehrheit hätte die Segmente wahrscheinlich einfach “falsch” übersetzt. Bei unseren Diskussionen ist uns aufgefallen, dass uns während unserer Zeit als Freelancer nie eine Agentur darauf hingewiesen hat, dass ein bestimmter Textabschnitt in einem Standard festgelegt ist, bzw. uns diese Standardübersetzungen zur Verfügung gestellt hat (dies gilt übrigens nicht für Pharma-Texte, dort wird dies von einigen Agenturen gemacht).

Daher sind wir zu der Überlegung gekommen, in Zukunft bei unseren Projekten die Übersetzer zu informieren, dass ein bestimmter Standard zur Anwendung kommt, bzw. die entsprechenden Texte zur Verfügung zu stellen.

Zum Schluss möchte ich mich noch bei allen Teilnehmern bedanken. Wir haben einiges lernen können und hoffen, dass auch die Übersetzer in Zukunft mehr auf die regulatorischen Vorgaben im Bereich Medizintechnik achten und sich entsprechend weiterbilden.

Um einiges zu klären – das sind keine Probeübersetzungen, sondern mehr eine Art “Umfrage”, wie Übersetzer mit manchen Themen umgehen. Dies hilft uns, unsere Arbeitsabläufe zu optimieren. Hier wurde jetzt einfach klar, dass vielen Übersetzern entweder nicht klar ist, dass es Standards gibt, oder den Text nicht als Standardtext erkennen, und wir als Agentur da etwas tun müssen. Das war mir persönlich so nicht klar, da ich mich schon seit Jahren viel mit Standards beschäftige und eigentlich dachte, dass die Thematik bei unseren Kollegen präsenter wäre, was jedoch leider nicht der Fall ist. Als Agentur haben wir von keinem unserer Übersetzer eine Probeübersetzung verlangt. Ich halte da nicht so viel davon. Übersetzer lassen sich auch ohne Probeübersetzung beurteilen. Manche Endkunden verlangen, dass wir Probeübersetzungen für sie machen, dafür habe ich auch viel Verständnis, bei dem Mist, der oft produziert wird, aber in diesen Fällen geben wir die Übersetzungen als ganz normale Aufträge an unsere Übersetzer.

Ansonsten bin ich der Meinung, dass Übersetzen Teamarbeit ist, und das Ziel darin besteht, dem Kunden eine optimale Übersetzung zu liefern. D. h. auch, dass niemand in dem Team (immer) perfekt sein muss, da das Team als Ganzes stabil genug ist, um einzelne Schwächen auszubügeln. Unsere “Umfragen” dienen genau dazu, herauszufinden, in welchem Bereich Schwächen bestehen und Lösungen dafür zu finden.

Die nächste “Probeübersetzungs-Umfrage” ist schon geplant, und wir würden uns freuen, wenn Sie wieder oder erstmalig daran teilnehmen würden!

Watch out! A new trend in pharma marketing – GIGO – SEO

In the past few months, we were involved in localizing various websites targeting certain patient populations. These projects were all sponsored/run by big pharma and these websites all claim to provide useful information, e.g. for people interested in participating in clinical studies or supporting patient education on health problems.

After a while it became obvious that most of these websites contain highly SEO optimized content serving only one purpose:  driving traffic to the pharma companies’ websites or their dedicated websites for given products/clinical studies.

Since these sites are extremely SEO optimized, which results in high rankings in the various search tools, they divert traffic from more impartial websites run e.g. by patient organizations.

Some might consider this a highly questionable trend in itself, but this is not my point.

The problem for me lies in the fact that huge parts of these web pages’ content seem to be created by marketing copy writers – it seems they’re given a list of SEO keywords, and they just have to produce page after page after page using these keywords.

Wrong and even dangerous contents

In contrast with what you would expect from a responsible pharma company, nobody seems to check this content, which results in statements such as:

-    The objective in diabetes treatment is to achieve the lowest possible blood glucose level.
This is not only wrong, but also extremely dangerous, as this would cause hypoglycemic coma.

-    The red blood cells transport oxygen to the lungs
This is plain wrong. The red blood cells transport oxygen from the lungs to the tissue.

-    Hemoglobin transports the carbon dioxide to the lungs
I consider this statement as being incorrect too, since only 5-10 percent of the carbon dioxide is transported by hemoglobin.

These examples have been edited so that you can’t identify the respective websites, but their aim is to help you understand my point that these websites don’t even get the most basic medical facts right. Looking at more complex content, e. g. relating to cancer treatment, the situation isn’t any better.

Localization requires more than just translating contents

Another aspect of these websites solely created for SEO purposes, is that they really don’t care about the reader. Quite often you will find that:
-    the only contact option they offer is a toll free phone number in the US (on the localized pages) which you can’t even contact from abroad,
-    they only provide links to English sources such as patient organizations
-    there are no literature references in the target languages.

What this means to the translation industry

As a language service provider, our role is to raise these issues with clients. We should not contribute to multiplying wrong or even dangerous content by translating it. We should also stress the fact that localization requires more than just translating the content.
By doing this we will not only help our clients by preventing costly legal actions if somebody gets harmed after following wrong instructions and by raising the quality of the content and giving the websites a more professional image. Badly localized websites also damage the reputation of our own industry, as many readers might believe it was the translator who introduced these errors.

Die QRD Vorlagen der Europäische Arzneimittelagentur (EMA) wurden wieder geändert

Die EMA hat am 12. Oktober 2011 ihre QRD (Quality Review of Documents) Vorlagen geändert. Diese sind sehr wichtige Tools für alle Sprachdienstleister, die im Bereich Regulatory Affairs tätig sind.

Die Vorlagen sind hier in allen europäischen Sprachen zum Herunterladen verfügbar.

The European Medicines Agency (EMA) has published new QRD templates again

On October 121th, 2011, the EMA updated its QRD (Quality Review of Documents). Those are very important tools for all language service providers (LSP) working in regulatory affairs.

The latest version of the multilingual templates can be downloaded here.

EMA news: electronic submission of information on medicines

Electronic submission of information on medicines

Source:  http://www.ema.europa.eu

The European Medicines Agency is preparing for the implementation of the electronic submission of information on medicines.

This is the first deliverable of the new pharmacovigilance legislation. It requires:

  • the Agency to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011;
  • marketing-authorisation holders to submit information to the Agency electronically on all medicinal products for human use authorised or registered in the European Union by 2 July 2012, using this format;
  • marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.

Details on the legal provisions and requirements can be found in:

Phases of implementation

The Agency is applying a phased approach to support the pharmaceutical industry with the implementation of the electronic submission.

Phase one: Notification of the electronic submission format

The Agency published the format for the notification of the electronic submission of medicinal product information in July 2011, which lists all of the data elements required, including the description of the characteristics of the substances contained in medicinal products. The Agency updated this information in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.

The Agency has published a list of controlled vocabularies, which companies should use to fill in fields of the extended EudraVigilance product report messages (XEVPRMs). This list is updated periodically. The XSD schema files and naming conventions for substances are also available.

Phase two: Electronic submission by marketing-authorisation holders

Marketing-authorisation holders can now submit information electronically using tools developed in-house by pharmaceutical companies or software vendors. XSD-compliant product information can be submitted via the EudraVigilance Gateway.

By the end of January 2012, marketing-authorisation holders will also be able to use data-entry and submission tools provided by the Agency. These tools will be designed for small and medium-sized enterprises to use, but will be available for any pharmaceutical company to use if it wishes.

The Agency is developing a training programme in collaboration with the Drug Information Association (DIA). The Agency will announce these training courses on this website and on the EudraVigilance website.

Phase three: Processing and validation of the submitted information

The Agency will process and validate the information submitted to ensure that it is accurate and up-to-date, with the assistance of a contractor.

If information is incomplete, missing or erroneous, the contractor will liaise with the marketing-authorisation holder on behalf of the Agency, to get hold of the correct information.

Phase four: Update of the format in compliance with the ISO IDMP standards

By the end of 2014, the Agency plans to update the initial format published in July 2011 in line with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. The IDMP standards are scheduled for finalisation in the first quarter of 2012.

The Agency is making all efforts to make sure that the information on medicines submitted by 1 July 2011 can be migrated in compliance with the future ISO IDMP standards. Most data elements and detailed descriptions of substances in the format published in July 2011 are aligned with the future ISO IDMP standards.

Therefore, marketing-authorisation holders should not need to resubmit data previously provided. However, the Agency will ask them to provide updates based on additional ISO data elements not included in the July 2011 format.

Working with the pharmaceutical industry

The Agency aims to work closely with pharmaceutical industry during the implementation of these measures, including hosting workshops to allow discussion of practical questions on the implementation of the submission process.

The Agency is also planning information days during 2011 and 2012 to raise awareness about the future ISO IDMP standards and to address marketing-authorisation holders’ questions:

Details of upcoming information days are also available on the EudraVigilance website.

The European Medicines Agency (EMA) has published new QRD templates

On July 22nd, 2011, the EMA updated its QRD (Quality Review of Documents). Those are very important tools for all language service providers (LSP) working in regulatory affairs.

The new multilingual templates can be downloaded here .