Main Subject - Business

If you haven't heard or read about the outsourcing trend, argument, discussion, fervor, whatever your side of it may be - especially the digital bridges of gold-pressed latnum being built in India, China and o

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

ther places outside our backyard; then you need to Google-it or Yahoo to your heart's satisfaction and move out from the cave of silence you've been in lately. What we are focusing on here is a simple case - '

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

Examples of combination products may in

uild IT and they shall come...'

India is closing the digital divide in the unique way that is being championed in our neck of the woods - digital divide education. By educating their people in what major comp

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

nies like IBM, Intel, SAP, Oracle, J.P. Morgan and a whole host of others, all global companies with technology based services and/or products who need tech-savvy employees to stay global and thereby attractin

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

investments in tech centers and other knowledge warehouses to communities worldwide. It has begun changing the way global companies do business to the degree where thousands of jobs are going overseas - outso

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

Combination pro

rcing to India as it is called.

Teach you children and they shall come...Build IT and they shall come, sound familiar. The reason for digital divide education in our own backyard should become clear by the en

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

of this article. Stop looking for handouts or complaining about the problem, when the solution has been within our reach for decades - and is being applied globally. In Ireland, China, Japan, Taiwan, India an

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

other countries they have been bringing in billions and changing the economy for years - while it looks as if we in the U.S. have been asleep at the wheel.

Other companies in the U.S. have been complaining a

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

out competing with companies that outsource in other countries to take advantage of lower wages or less taxes. Employees are complaining about losing jobs to other countries for the same reasons.

My viewpoint

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

again is for the same companies and employees invest time and money in their own backyards and return the billions that the global companies are spending overseas back to the U.S.

Don't have the resources to

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

uild a tech center for training, then use your neighborhood church, community center, library, public or private schools, daycare centers or mansion from a very eleemosynary community leader. Take the time to

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

Following aspects would a

retrain employees to certify in what is being sought overseas and at home in the U.S., educate children in the community with math, science, technology and other required courses. Invest time in staying in the

dd to the challenges in developing combination products:

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

public or private schools to interest children in working to fill the digital divide that is fracturing America.

I'm sure the question of time involved in training people or getting children thru school or in

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

erested in these fields may seem like a greater hurdle than the digital divide itself. Has anyone considered what it would cost in time and money as we continually have to layoff employees and consolidate proj

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

cts to burden a smaller workforce? If our companies have laid-off employees in the past - how much time is left before Acham's razor fall's on another department? Is your company spending time and/or money in

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

work-study program of any kind? Any time being spent at local colleges and universities? Local or private schools? All these options are being used in outsourcing to India, and other countries. Outsourcing to

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

Professional from academic institutions, pharmaceutical industries, health care indust

India creates a digital bridge of gold-pressed latnum to not only this country but several others. And where do you think they learned all these options, whether the programs are true to the original or added

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

ariations? In America.

The countries where all these billions are going toward closing the digital divide in their part of the world by using digital divide education I might add - have sent their citizens he

.

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

e to the U.S. to get their degrees, certifications and knowledge of technology. They in turn went home to their respective countries and educated their communities where they once lived, grew up and shopped.

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

Companies that provide selfless information through particip

he same can be done right here at home in the U.S., digital divide education works and we have proof - even if it isn't in our own backyard...yet.

Digital divide education - Build IT and they will come...home

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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I once heard a co-worker describe the job as something between a magnified EMT and a bench warmer. Such flattery - but what can you do?

Strategic planning is important for organisations to succeed but is not enough. They need to ensure the strategy is understood by employees and measured in a manner which is relevant to them. Building a balanced scorecard rather than one built solely on financial metrics will provide employees with a sense of how they contribute to the strategy.

Benchmarking for dollars is not just for Fortune 500 companies anymore, and it does not have to be a difficult or expensive process. A simple benchmark may be as straightforward as studying a competing website or auction to learn a few tricks you can apply to your own product or service offer.

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Main Subject - Build IT and They Shall Come... Digital Divide Education

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