Translated a cover letter, with 2 appendices, to a German regional ethics commission, regarding a proposed extension study for a previously approved clinical study. Approximately 1,500 words.
Continued translating a Summary of Product Characteristics for a chemotherapy drug. Completed approximately 2,000 more words.
Translation in progress on an EMA Summary of Product Characteristics for a chemotherapy drug. This is my first opportunity to apply what I’ve learned about EMA product information templates, etc.
I’ve been taking a break from translation for a while due to the birth of my son Ambrose. A nice vacation, but it’s time to get back to work!
Translated a hospital ethics committee’s assessment of a proposed clinical trial. Approx. 1,000 words.
This evening I read the EPAR Summary for the Public (3 pages), and the EPAR Product Information (24 pages) for Vyndaqel (tafamidis). The central marketing authorization for Vyndaqel is the most recent one to have been issued by the European Medicines Agency (November 16, 2011).
Vyndaqel is used in the treatment of transthyretin amyloidosis, a disease which is sufficiently rare that the drug has received an “orphan medicine” designation, and the marketing authorization was issued under “exceptional circumstances”. The purpose of these designations is to encourage pharmaceutical companies to develop and market drugs for the treatment of rare diseases. Some interesting background on the regulatory climate in the US and EU for orphan drugs is available in wikipedia.
The EPAR product information for Vyndaqel was only about 10% as long as what I’ve seen for generic drugs for more common diseases. In part, this is due to Vyndaqel only being marketed in a single dosage form and dose. Hence there was less need for repetition in Annex III (Labelling and Package Leaflet). However, the Summary of Product Characteristics was also surprisingly short. This is due to the more limited scope of required human studies for an orphan drug to gain marketing authorization.
I’m deliberately in between projects for the time being, as my wife will likely give birth in the next week or two. In the meantime, I’m brushing up on basic sciences, and in particular am studying the latest edition of a standard, concise German physics textbook for pharmacy students.
In order to really internalize the terminology, I’ve decided to translate this textbook. For reasons of copyright, this translation will be strictly for my own private use. I’m also avoiding all use of machine translation on this project, in order to avoid transmitting any part of the text to a third party.
So far, I’ve used Trados to convert the PDF to a Word document, have broken the exceedingly long document down into chapters, and have begun translating the front matter. The total word count for the concise textbook is approximately 54,000. Word count translated today, approx. 300.
Trados is obviously not an OCR application, but in this case the original PDF includes an accurate text layer. Trados did a nice job converting this very long PDF document to .docx format.
To save time clicking around, a list of direct links to EPAR summaries for the public can be retrieved from Google using a search expression like:
“EPAR summary for the public” filetype:pdf site:ema.europa.eu
The results can be filtered by date, either using the “Custom Date Range” feature on the results page, or by going directly to a URL such as the following:
Note the qdr:m parameter, which indicates that results should be limited to new content from the past month
My contact at the pharmaceutical translation agency in Germany has passed along a link to the European Medicines Agency’s templates for product information concerning human medicines. The EMA is a decentralized agency of the European Union, and is responsible for the the scientific evaluation and supervision of human and animal medicines. The templates have been developed by the The EMA’s Working Group on Quality Review of Documents (QRD).
I’ll share that link — and you can guess what I’ll be studying next:
EMA product information templates
The scope of the QRD’s work is as follows:
The Working Group on Quality Review of Documents (QRD) provides assistance to the European Medicines Agency’s scientific committees and to companies on linguistic aspects of the product information for medicines. This includes summaries of product characteristics, labelling and package leaflets.
The QRD’s tasks include:
- ensuring linguistic clarity, consistency and accuracy of the product information;
- verifying the terminology used in translations and their consistency with the original versions;
- promoting legibility of product information;
- reviewing and updating templates for opinions of the scientific committees and for product information, to ensure compliance with European Union (EU) rules on medicinal products and taking practical experience into account;
- contributing to the development of a common understanding on the implementation of legislation and guidelines in relation to product information and labelling
Two links from the product information templates page stand out as being of particular interest to translators:
Three things are of particular interest with respect to QRD’s oversight of product information:
Examples of product information can be found uder the Find Medicines section of the EMA’s website. The product information includes a summary of the product’s European Public Assessment Report (EPAR), and the full text of the EPAR. The summary is intended for the general public.
Under the human medicines section, there are currenly 773 products listed. That relatively small number is due to the fact that the EMA only deals with medicines which have been referred to it, due to some disagreement between member states. It’s such a small number that conceivably a human being could read a reasonable fraction of the corpus within a few months, and thereby become a subject expert.
The structure of an EPAR consists of three Annexes:
It’s unclear how much of this material would require translation into English. The guidelines for the linguistic review process mention that “[a]t submission and during assessment, only the English language version (EN) of the product information is submitted and reviewed”. However, possibly German, Swiss, and Austrian drug manufacturers would prepare the first version entirely in German, and have it translated into English for submission.
An initial reading program related to EPARs could be carried out as follows: 1) sort the list of products in descending order of authorization/refusal date 1) read the entire EPAR for the first few products, 2) continue reading selected summaries and package leaflets.
A further skill to be developed would naturally be facility with British English, which is the official variant for use in EU agency documents.
Finished translating the medical journal article mentioned in the preceding log (Zumkley). Since that time have completed 4 additional articles (Okonek, Voigtman, Weißenbacher, and Jung). Total word count for all 5 articles: approx. 19,000.
Average number of words translated per day from November 22-25: approx. 4,800. Citations will be posted later. Time for a break now.
Translation in progress on a medical journal article dealing with dialysis encephalopathy due to aluminum-containing dialysis water. 50% complete, total word count approx. 3,400.
Citation: Zumkley, H., EP Schmidt, HP Bertram, A. Lison, B. Winterberg, C. Spieker, H. Losse: Aluminiumintoxication, eine iatrogene Pathologie. Verh. Dtsch. Ges. Inn. Med. 89, 1227-1235 (1983).
Translated a medical journal article on the treatment of acute paraquat poisoning with continuous hemoperfusion. Approx. 5,900 words, with 4 tables and 11 figures.
Citation: Okonek, S.: Neue Konzepte zur Therapie der Paraquat-Vergiftung. Therapiewoche 34, pp. 4166-4178 (1984).
