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Can you tell me, aside from all the obvious such as positive attitude, outgoing personalities, se

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

nse of teaching, etc.,etc., what is the one quality that every great leader has in common?

We kn

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

Examples of combination products may in

w about the obvious things such as visions,setting goals, planning and taking actions. This is th

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

one quality that without its presence, there would be no leadership.

I will give you my take on

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

the subject. In order to be a great leader, no matter who you are or how powerful your heritage,

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

Combination pro

ou MUST have the WILLINGNESS TO LEARN.

Do you think that our Presidents come into office knowing

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

all there is to know about running a country? Absolutely NOT! They must be willing to research d

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

fferent avenues of resolving issues, creating plans, setting goals and setting forth plans of act

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

on. All of the obvious things that I mentioned before but in order for these things to happen, yo

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

must be willing to aquire the knowledge to do so.

No matter how much education you have had or

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

ow much of a genius you have become, there is always something to learn. Once you lose the willin

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

Following aspects would a

gness to learn, your leadership powers will fade like a red blouse washed in hot water! Gradually

dd to the challenges in developing combination products:

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

all of the other qualities that have empowered your presence will fade away and your leadership w

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

ll dwindle. People will begin to look for new leadership with fresh ideas.

Their ideas are fresh

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

because they allowed themselves to learn new things. Your current knowledge will only carry you s

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

far before it becomes stale and boring.

It would be a lot like trying to write books or article

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

Professional from academic institutions, pharmaceutical industries, health care indust

s using the same content that is stored in your brain without adding anything new. KNOWLEDGE is p

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

wer and POWER is maintained by creativity and CREATIVITY is fed by WILLINGNESS TO LEARN.

Always

.

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

eep your mind open to knowledge. Thirst for it like a tree thirsts for rain and you will begin to

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

Companies that provide selfless information through particip

flourish and grow while imbedding strongly implanted roots into the foundation of your leadership

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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Love him or hate him, small businesses can learn a lot about marketing from Howard Stern.

If you are a net worker and want to become more efficient on meeting the right people, well then let me suggest not being the first person at the event or party. You see it makes sense to let the crowd sort itself out first. You can allow the shameless sales people and hardcore party pitchers to make their sales spiels and let the party separate into groups.

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