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Pharmaceutical and Medical Device Translations

Pharmaceutical and Medical Device Translations

By | Pharmaceutical Translation | One Comment

As with just about every industry today, products are being marketed to the international community. In most cases, whether it’s a product handbook or a warranty document, accuracy is important in professional medical translation and that means 100 percent accuracy. If there is even one mistake in either a pharmaceutical translation or a medical device translation the recipient could get seriously injured.

The sorts of details that need to be translated include measurement units that must be recorded accurately otherwise the user may not take enough or take too much of the drug resulting in some dangerous side-effects. Other information includes that found on packaging and information leaflets. If a medicine is in pill or tablet form and has a dosage clearly written on the label in the languages of the likely recipient it’s unlikely that the product will be misused.

However, if a medicine is given as a powder or syrup the amount to be taken has to be clearly illustrated. If the pharmaceutical is being prescribed to an American, but in metric form, it’s important that the product advertises the amount to be taken in the right measuring language. Americans aren’t necessarily proficient at understanding metric quantities.

The packaging on the drug NyQuil is a good example as it includes both the US customarily used units as well as metric units, so 30 mL equates to 2 TBSP. these need to be translated into key languages used in the targeted countries.

Drugs versus medical devices

The initial stage of a drug trial focuses on a small unit of healthy patients first however with medical devices it’s not acceptable to install them on people who have no need for them. Also, devices typically require a smaller study group in order to demonstrate the safety and effectiveness of them than pharmaceuticals require. So, the 4 phase study for pharmaceuticals comprises a healthy population group, a small affected population, a larger affected population and the post-approval study is substituted for a 3 stage process, which comprises a small pilot group, a bigger patient group and a post-approval group.

What’s important about a translator?

100 percent accuracy is the goal of any professional medical translation, so the translator should be very familiar with the correct term in order to ensure readability, accuracy and the credibility of the author of the text. The deeper the pharmaceutical and device translator’s knowledge of the vital subject matter, including documents that have come from the country’s regulatory body the better the translation of the required documents.

Pharmaceutical Manufacturing

Translating in a Pharmaceutical Manufacturing Environment

By | Pharmaceutical Translation | No Comments

Language is so much based on context that when a lot of time has been spent writing a text it still may be open to the way the reader interprets it. This is even true with translations. It is only those translations that have been completed by a highly trained and experienced translator will mean that interpretation of the translated text resembles that of the source text.

There are some pharmaceutical interpretations that may have a narrow interpretation and those that have a broader scope for translation. The problem arises is how the reader should safely interpret the information provided in the pharmaceutical document. If a translator from pharmaceutical translation services, is presented with a pharmaceutical document and doesn’t fully understand the document his or herself because of ambiguities present the only recourse is to go back to the person who wrote the document in the 1st place. Translators for medical translation services who are not given this option should inform their clients of any contradictions or ambiguities found in the source document. It doesn’t take much to work out who is likely to be held responsible for any contradictions or ambiguities that are found in the translation.

Once the translator has gained a reasonable understanding of the source document for the medical and pharmaceutical translation, the translation is almost ready to commence. There are a few other things that need to be considered apart from the actual meaning of the text. These are the voice, mood and person used with the verb. Whether an action needs to be performed or there is a choice. Instructions need to be expressed and translated in the same way in the original as in the translated documents. In the standard operating procedures used in the pharmaceutical industry it’s important that consistency in meaning is maintained to ensure the product is used appropriately.

Another common issue in English is the use of words used in instructions like check and other verbs suggesting an action. For example, you should check for leaks. This appears to mean that the product instructions are telling you to make sure there are no leaks. It could read that you are told to make sure there are leaks. It’s important for the translator of medical and pharmaceutical translations that the precise meaning of the instruction is clear so that it can be translated into the targeted language without compromising the meaning.

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