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While there are many qualities that differentiate a leader from the rest of the pack, there are some important ones that are common to most business le

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

aders that help them to manage work and people. These are as follows.

Ambition:–
The person with a dream is the most likely to attain success, si

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

Examples of combination products may in

ply because he or she has a goal to work towards. Someone with the drive and high aspirations will be propelled towards the determination and diligence

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

to make a success of their business. Every great leader, in business and in other fields of life has an objective that they work to achieve and this b

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

comes the driving force that shows others the vision of what can be. This inspires the leader and the people around him or her towards the actions requ

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

Combination pro

ired to make the vision a reality.

Knowledge of the business:–
A sound understanding of the dynamics of the business that they are in is a common

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

quality amongst great business leaders. They learn from books, people and experience to develop a keen sense of the workings and history of their busin

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

ess. While this is essential for any business person, it is an art mastered by leaders that makes them highly successful at their work.

Consistency:–<

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

r> Consistent behavior inspires trust and is the foundation for integrity. The higher or nobler qualities of character such as integrity, concern for

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

people, honesty work only when applied with consistency. The people who look to leaders for guidance or inspiration do so because they believe that a l

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

ader will give the right answer every time. This is possible only through consistency of thought and action.

Good listening skills:–
All the soft

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

Following aspects would a

skills are important for a leader but one of the most essential leadership skills in business management is being a good listener. This allows the lea

dd to the challenges in developing combination products:

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

ers to pick up on little facts that many overlook. Listening contributes to the knowledge base of the individual as opposed to speaking, which only imp

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

arts knowledge to others. The leader is also able to inspire confidence and attract people to him or her because they know the leader is listening.

Cr

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

ativity:–
A good deal of being a leader is to think on your feet. Your situation and environment change constantly in the business world and a goo

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

d business leader keeps an open mind. A leader will adapt quickly to new information and have the creativity and vision to handle change.

Ability to o

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

Professional from academic institutions, pharmaceutical industries, health care indust

n up to mistakes:–
A leader manages problem situations by owning up to mistakes and taking the blame in place of trying to cover mistakes up or pa

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

ss the buck. This is a sign of true integrity and inspires others to stand by him or her in a time of crisis. If a leader were to try and cover up the

.

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

istake, people would respond in an angry, indignant manner and he or she would lose all the trust and power vested in him/ her.

Decision-making skills

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

Companies that provide selfless information through particip

:–
A strong business leader is decisive and has the courage to stand by the decision taken. This is the hallmark of all great managers and leaders

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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