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Changing roles from employee to leader can be fun and very rewarding. It usually brings about more

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

pay, more responsibility, and prestige. But it can also bring about some potential pitfalls as well

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

Examples of combination products may in

Here are 3 areas you can anticipate in advance as potential problems.

First of all, many of us ju

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

p into our new role and never really know what is expected of us. We find out as time goes on just

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

what we are not doing, typically from tough feedback from our manager. Take some time and study you

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

Combination pro

job description. Write down what you perceive as deliverables, goals, and objectives. Then ask fo

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

some time with your manager to find out from her perspective what she expects. Then make sure that

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

you are meeting with your manager weekly to receive feedback on your performance.

Second, you must

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

understand that “what got you here will not keep you here.” You may have been the best performing t

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

am member, never late, never absent, and able to perform all functions within the team. But your ro

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

e as team leader is NOT to do the work, but rather accomplish goals and objectives through others.

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

Following aspects would a

Also known as delegation. Let go of the idea that you can do it better and faster than anyone. You

dd to the challenges in developing combination products:

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

goal is to build a team that is as close to self-sufficient as possible. They should perform the s

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

me when you are gone as they do when you are present.

And finally, remember that leadership is abou

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

t people. Providing support, direction, and motivation is what you are getting paid for. You would

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

not be in your role if you did not have people on your team. Your success depends on their success,

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

Professional from academic institutions, pharmaceutical industries, health care indust

so focus on making your team members a successful and you are sure to be doing well yourself. If yo

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

u are into being a leader just for the money and power, your career will end in just a few short yea

.

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

s.

Go to our website at www.LeadershipMentor.net and you will find audio session available to liste

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

Companies that provide selfless information through particip

to free of charge. Don’t leave Leadership to just happen, start to learn as much as you can today!

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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