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It is a common belief that management and leadership are the same role. While it is common that a manager also plays the part of

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

the leader, these two roles are truly separate in function and in the way they add to the success of an orginization. By understa

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

Examples of combination products may in

ding the difference between management and leadership you will become more effective in helping others see the road ahead.

To un

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

derstand the difference between management and leadership, consider the construction of a new road. To build that road there are

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

workers, machinery and tools which are all vital in the road’s construction. Managers help ensure those workers, machinery and to

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

Combination pro

ols work together in the most efficient way possible. A manager makes sure those workers are well-trained, motivated, rested and

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

that they know what they’re supposed to do next. The manager does the same thing with the tools and the machinery to make sure t

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

hat they’re working correctly and that the workers are able to use them efficiently and safely. This is the role of management.

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

n the other hand, a leader makes sure that the road is going in the right direction before the construction begins. That leader

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

also monitors conditions in new situations to ensure that the road under construction is still the correct one and is still going

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

in the right direction.

How does this affect you as a leader? Are you spending your time managing people when you should be maki

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

Following aspects would a

ng sure that the road ahead is the one that you want to be on? To expect to be an effective leader you must present a clear visio

dd to the challenges in developing combination products:

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

and a trail you are willing to walk on first. While there are times when it is appropriate for a leader to fill a management rol

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

e, it is vital to understand the difference between leadership and management so you can be effective no matter which role you ha

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

pen to be filling at a given time. If you are a leader overseeing managers, it is important that you provide them with the correc

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

t perspective so they may be effective in their management role. Don’t manage the managers. Lead them.

If you are not in a forma

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

Professional from academic institutions, pharmaceutical industries, health care indust

leadership role, it is also important that you understand that when a leadership opportunity arises there is a difference betwee

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

n being a leader and managing the effort. Even if you end up filling both sets of shoes it’s important to understand the differen

.

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

e in roles in order to fill them effectively. If, on the other hand, you learn how to lead by showing people that you are walking

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

Companies that provide selfless information through particip

down the right road, you will become a natural leader and will be able to help many others find success as your achieve your own

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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Situation may arise when you are opening a dollar store in which inventory levels have fallen way below acceptable levels. It does not matter what the reason, it is important to address the situation as quickly as possible. The obvious way to address the problem is to order additional merchandise to place on the sale floor.

At first glance, this question may seem a little silly. Of course I know what my job is. But in my experience, from both sides of the fence, many of us find out the hard way just what is expected of ...

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