Advice You - Business

Getting a translation done can be a serious business. Maybe not if you are only having a brief email translated, but definitely so if you are dealing w

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ith business documents, reports of anything that will be printed. Many people however approach translation too lightly believing it is an easy, quick a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nd straightforward process. This is far from the truth.

Translation is a complex affair and needs to be approached sensibly in order to avoid poor res

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

lts. Before starting a project that involves translation, consider the following common thoughts people have about translation services. Do you think t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

he same?

I know a foreign language, I can be a translator

This is perhaps the most common misconception about translation. Being able to read,

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

speak and write a foreign language does not give anyone licence to undertake translation work. Firstly, a translator needs to have a proper, in-depth a

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nd fluent understanding of at least two languages: a foreign language and a mother tongue language. Secondly, translating is a skill. You must be able

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

o write well and have an excellent command of linguistic nuances. Thirdly, language is all the more complex due to cultural influences. If the culture

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

behind the language which is being translated is not appreciated, an accurate translation is extremely difficult.

Translation is easy

Translat

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

on is not easy at all. It can be very intricate, complex and painstaking work. It requires a great deal of concentration and patience, as well as a kee

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

n eye for detail. Translation is also mentally tiring; this is because a translator is continuously moving between two languages and mind frames. A tra

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

nslator must first read and register source information then manage to digest it and present it accurately in the target language.

Computers can no

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

do translations

No CAT (computer assisted translation) will ever be able to translate anything with 100% accuracy. Some can and do provide impres

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

sive “gist” translations but if you are relying on accuracy, no CAT can be trusted to deliver. This is because computers do not understand what languag

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

is, how it is used, the subtleties within it and the ever changing use of it.

Having a professional translation is not crucial

True, a profes

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

sional translator may not always be necessary. However this depends on what the document is and how it will be used. If the translation is to be accur

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

tely and professionally prepared then an experienced translator is a must. Poor “DIY” translations lead to many problems such as people misunderstandin

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

g texts, getting the wrong information or even having to pay to get the translation re-done. One can use the following analogy: If you want your car fi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ed you take it to a mechanic, not a car photographer. The latter may know a bit about cars but not enough to fix your engine.

In conclusion, if you ar

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e in need of a decent, professional translation then accept only the work of accredited, professional and reputable translation agencies or translators

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Facial expressions- be aware of what you are saying to peopel when you're not saying a thing.

It is rather a difficult job to critically analyze and report on an e-book in as much as the critical report has to be in such a way as not to hurt anyone. I have tried my best to make this critical report in such a way as not to harm the feelings of anyone concerned.

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