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I came to India in order to access its workforce and I expected that all college graduates have strong language skills in English. After I spent a couple of months,

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

I found that Indian college graduates have a lot of potential to become great workforce; however, they need some training when jobs require them to speak and write i

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

Examples of combination products may in

n English competently. Especially when they work for companies headquartered in US, UK, Australia and Canada (and other English speaking countries), the training is

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

mandatory. The followings are areas in which they need some training.

Indian college graduates tend to write incomplete sentences and make many grammatical mistak

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

es. Also they omit commas, periods and apostrophes. They often forget to capitalize certain letters, too. When they are instructed to not make those mistakes, they m

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

Combination pro

ke a lot less mistakes. Also in most cases, they can find mistakes that they make. However, some training is definitely needed in this area so that they write proper

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

ly subconsciously. All courses in college are taught in English expect for language courses like Hindi, Chinese and Spanish, but after all, they are not used to spea

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

k and write in English as a part of their daily life; this is probably the reason why they make mistakes that even they recognize.

Another common problem is spellin

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

g; more specifically, too many words are spelled in the way that they are often used in chartrooms and text messaging. While they understand that they cannot use spe

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

llings used in chartrooms and text messaging when they write official documents, they subconsciously use those spellings because it is a habit. Some training is need

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

d in this area also.

Generally speaking, if they can write while they make few grammatical mistakes and make few misspellings, they can handle most tasks in English

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

Following aspects would a

, but once they take senior positions such as managers and consultants who directly work with clients of American nationals and British nationals, they need to be ab

dd to the challenges in developing combination products:

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

le to convey what they intend to inform very clearly in their writing. Most Indian college graduates lack experience in this type of writing. It is true that even

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

native English speakers need to practice to be good at this type of writing, but that obviously does not imply that Indian college graduates are excused because of t

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

hat. On the contrary, they need to practice even more to be at least as competent as native English speaker college graduates.

Also Indian college graduates have a

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

recognizable accent. It is not absolutely necessary for them to change their accent, but they should learn how to speak slightly differently. For example, they can s

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

Professional from academic institutions, pharmaceutical industries, health care indust

peak slowly. They can imitate Americans and British (and other English speaking people). While having an accent is not a technical problem, it can result in a commun

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

ication problem. It is rather important that they recognize that they are not making any technical mistakes in this regard, but it is also important that they need t

.

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

o change the way in which they speak slightly when they speak with Americans and British (and other English speaking people).

Over all, Indian college graduates hav

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

Companies that provide selfless information through particip

e good language skills in English, but they are a bit rough. They have a lot of potential, but if they want to become competitive, some training in English is needed

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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