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As a Christian leader, you are held to high moral, ethical, and social standards. As a leader, you are held to high standards, but as a Christian leader, that bar is raised even higher. Wh

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

y? Because both the Christian and non-Christian social environment has tended to expect that Christians measure up to their self-proclaimed moral and ethical standards, as they rightly shou

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

Examples of combination products may in

ld. What can you do to be sure you ‘stand up to the test’ in the area of Christian leadership?

1) Probably the most important thing you can do as a Christian leader is to clean up your act

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

---if there is anything in your life, moral or ethical, which would not stand up to scrutiny if the entire world found out---you must eliminate it immediately. Do not give anyone an occasio

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

n to think that you are a hypocrite.

2) Be sure that every decision you make is honest and ethical. You cannot effectively lead, as a Christian or not, when your decisions and actions are

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

Combination pro

not above-board, fair, and honest.

3) As a Christian leader, commit to telling the truth no matter what. As a Christian leader, when you lie or tell half-truths, people tend to feel that y

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

our entire faith is a sham. In fact, if you are habitually lying and telling half-truths, your faith may indeed be a sham.

4) Learn everything you can about the tasks at hand, even if it m

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

eans working in the trenches for awhile. No one likes to be led by someone who has never done what they are doing. This doesn’t mean you have to become an expert, just participate in the m

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

enial work long enough to understand the frustrating aspects of the work. Another benefit to this is, when you have actually done the work, you can more effectively brainstorm solutions to

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

challenges when they arise.

5) Lead by example. Do you expect your employees or secretaries to arrive on time for work, and dressed well? Then you must do the same. Sometimes it is so ea

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

sy to think that you have earned the right to come in whenever you feel like it, or to return from lunch whenever you wish. Sure, you may have earned the right, but you gain far more by set

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

Following aspects would a

ting the example for performance. Do you expect others to work overtime when a project is behind projections? Then you must be willing to do the same.

6) Although you may feel you have ea

dd to the challenges in developing combination products:

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

rned the right to delegate away all the work, continue to be involved in productive tasks. By doing some of the work, not only do you gain the respect of your employees, but also you keep i

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

n touch with the flow of things. As a leader, it is easy to become disengaged from the actual productive segment of your business, and resultantly make decisions that look good on paper and

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

sound good around the boardroom table, but are actually worthless when the rubber hits the road.

7) Constantly reevaluate your own performance. Often, you may spend so much time correctin

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

g the actions of others and solving crises you didn’t create, that you develop a sense that others aren’t as capable as you. Consequently, you may not recognize when you are falling into ba

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

Professional from academic institutions, pharmaceutical industries, health care indust

d habits that also need to be corrected. Be the first to recognize and correct your own short-fallings.

8) Avoid pride. Once in a position of leadership, especially if you are good at wha

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

t you do, it is easy to begin to feel that you are invincible. Once that occurs, you become vulnerable to pride, and may make decisions you would frown on if your subordinates made the same

.

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

decisions. Maintain full responsibility for your actions, and keep them above-board at all times.

Bonus Step:

9) Learn to manage your time. When you are in a position of leadership and

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

Companies that provide selfless information through particip

find yourself delegating away most of the time-consuming tasks, it is easy to lose control of your time. Again, when your employees see you wasting your time, they will tend to do the same.

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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