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Generally leadership and leader skills themselves require a professional knowledge, good practic

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

e and often intuition. It truly requires powerful potential from a pile of dull grey rubble. Som

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

Examples of combination products may in

times the purpose of leadership is instructive, interactive, participative, mentoring, or dictat

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

orial. In all cases, leadership involves influence and power.

When defining leadership power, i

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

is critical to appreciate that the perception of someone as a leader is just as important as th

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

Combination pro

e legitimacy of that perception. Once the perception is defined and accepted by the group, its

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

egitimacy becomes mute. But leadership has to be recognized by others in order to be effectively

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

used. The important issues to remember about leadership are that perception is just as importa

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

t as the position, rank, or office; and effective leadership occurs when everyone knows exactly

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

what is expected, and what the rewards or risks will be. Scientists have developed six power cat

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

gories which are necessary to be a real leader. They defined coercive power, expert power, infor

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

Following aspects would a

mation power, legitimate power, referent power and reward power. All of these powers however, wo

dd to the challenges in developing combination products:

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

ld not be useful and effective if a person could not impress people by his potential. Good poten

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

tial for leader is the ability to not divide and separate but to join without personal exception

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

In such case people surrounding a leader would come to realize that he would not give them an 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

ssignment that he himself was not willing to lead, and therefore because of his willingness to s

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

Professional from academic institutions, pharmaceutical industries, health care indust

are the risk, his men were able to accomplish their goals with a high level of confidence and pr

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

ofessionalism.

So why is leadership important to an organization? Without leadership the organi

.

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

ation will lack focus or direction, and without direction there will not be any destination. The

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

Companies that provide selfless information through particip

refore, if the organization cannot find out where to go, then any road are open to a real leader

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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