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Is that the best you can do? What a powerful question. It can be used in many business application

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

s: negotiation, project management, self-analysis, and many, many more.

Those seven little words have sa

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

Examples of combination products may in

ed me thousands and thousands of dollars. They can be used in nearly any negotiating scenario. I've used

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

hem at flea markets, craft bizaars, sales counters, and the internet. As long as you ask the question in

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

matter of fact tone (never with a feeling of accusation), it doesn't cast doubt on the product or the pe

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

Combination pro

son you are doing business with. The person to whom you have asked the question really only has two respo

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

ses. Both are positive. If the answer is yes, then you continue your discussion. If the answer is no, th

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

n it requires an explanation . . . a lowered price . . . a quicker delivery . . . or a better product.

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

n project management the question can be asked of each team member and the answers can be revealing. I've

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

heard one person reply, "No. It's frustrating. I could do better. I should do better, but I'm just not ge

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

ting the information back from the client as quickly as I need. Sometimes when I get the information, i

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

Following aspects would a

's too late for other options." After hearing this explanation, we turned the information around and comm

dd to the challenges in developing combination products:

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

nicated our concerns to the client. They didn't understand that a single e-mail or phone call could have

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

aved them money. They were focused on a paper trail.

Many people strive for perfection and they want to

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

e the best they can be. Some people never think about it. Even asking the question would be a shock to th

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

ir system. Is this the best I can do? Is this the best WE can do? Sometimes even answering "yes" leaves a

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

Professional from academic institutions, pharmaceutical industries, health care indust

little gnawing dought in the back of your mind, which can surface the next time you work on the same ty

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

e of project. If the doubt is there, then there must be a way to improve . . . and if we can improve . .

.

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

we CAN do better.

A simple question and a complicated answer can result in improved work methods, posit

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

Companies that provide selfless information through particip

ve communications, lower prices and better people . . . is this the best we can do? You better believe it

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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When Control Solutions, one of USA's biggest accounting firms dealing with Sarbanes-Oxley (SOX) accounting compliance procedures, wanted to recruit accountants for its expanding practice, it looked at Enabilizer, a New Delhi-based accounting outsourcing firm. That look has led to the two signing a joint venture agreement that allows Control Solutions to outsource its SOX work to the Indian JV.

With the news of a new round of layoffs in the automotive industry, this article points to the impacts affecting the local economies, the families and the children. In this article, there are listed 3 steps that each affected family should be looking at taking now. All of the rest of us who will be indirectly affected need to take a look at these steps to begin to prepare ourselves for a very soft landing in the event we experience the same situation and scenario.

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