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Dictator, Imperial or democratic are different types of administration for many different countries in the world. All of them have one thing

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

in common. There is always one person at the top. The difference lies in how the delegation of power is distributed & the structure of its

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

Examples of combination products may in

ierarchy.

The above analogy can be applied to an office environment. There is the main boss, principal or Chief Executive Officer (C.E.O.),

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

the upper management, lower management, & the normal workers. Different companies may have different management styles as the above example.

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

However, the hierarchy of position still remains as we know who everybody is because of the chain of command in an office environment. Basi

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

Combination pro

cally we can adhere to a guideline to help us maintain a feasible working relationship with our office subordinates, peers, office superiors

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

& bosses.

• The number one rule we should know is how to avoid offending the boss. Remember that an office hierarchy is traditionally not f

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

at. It is shaped like a pyramid with one point at the top. Offending anybody from any of the levels above your level will ensure that you st

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

y where you are or even demoted to a lower level.

• A good trait we should develop is leadership communication skills for succession. Pract

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

ice good public speaking, leadership skills, & set an example to co-workers as they may look up to you one day in the future.

• Never forge

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

your status in the office. Act appropriately to other people according to their position in the office. You can act superior to people at l

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

Following aspects would a

wer rank than your position but you should act humble to those above your rank.

• The hierarchy must be understood & respected. Find out wh

dd to the challenges in developing combination products:

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

t type of management structure the office practices. Is the boss very social with the workers or prefer the office to be managed by another

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

person? Who is your direct superior? Do not bypass your direct superior over office matters unless instructed by a higher ranking boss.

• T

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

e position must be respected even though you do not respect the person. Perhaps you know of a person’s lifestyle preference outside of the o

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

fice. The person may not deserve your respect outside of the office but a person’s position in the office hierarchy must remain respected to

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

Professional from academic institutions, pharmaceutical industries, health care indust

maintain a good & conducive working environment.

• Understand the upwards & downwards communication in the office hierarchy. Practice good

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

interpersonal communication skills with as many people in different rank levels of the office hierarchy. It can increase your chances of bei

.

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

g a favorable candidate for a promotion. Also, it should help you maintain good office relationships.

Apply it well to your career and you

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

Companies that provide selfless information through particip

an be on a path to a higher rank up the traditional office hierarchy pyramid instead of being stagnant, demoted or shown the early exit door

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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Talks of the steps involved in Six Sigma Project Selection, brainstorming and using a questionaire, and variation.

Developing a power-image to identify your business creates memorable recognition in the minds of your clients. It brings them back to do business with you because they remember you. What have you done recently to make your business memorable? Try a brand?

It is all out war in finding good companies to work for these days. As people scramble for an edge in winning out over other candidates, there are some rules of the hunt that are truly different.

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