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Many professionals and managers are so involved in day-to-day crises and fighting fires that they f

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

orget about a key leadership characteristic: self-management. Effective leaders are first of all

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

Examples of combination products may in

effective in managing themselves – their time, their focus, their emotions and their careers. It’s

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

too late to figure out what’s next for you once your company has merged, had lay offs, changed str

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

ategy or whatever. Here are the biggest mistakes leaders make in their careers.

Burning bridge

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

Combination pro

s along the way.
Each profession may seem big – but, as you move up in your career, you co

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

me to realize how ‘small’ each really is. Something you said or done may comes back to haunt you.

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

Not having big enough goals.
A key career stopper is setting your goals too low or not

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

being willing to put in the time it takes to reach goals. Believing “I could never do that” or, “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

hey’ll never give me the go ahead” means it probably won’t happen. Take risks, try new things, ini

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

tiate and learn and grow.

Playing office politics.
Some people pick the wrong battles

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

Following aspects would a

to fight. When you get enmeshed in gossiping or office politics, you forget about the goals, missi

dd to the challenges in developing combination products:

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

on and getting the job done. It’ll lead to a lack of outcomes – a career killer every time.

Ha

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

ving a bad attitude.
“It kills even the most talented,” said one top executive, who has ob

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

served many talented people rise and fall. Attitudes are learned, and you can improve yours daily b

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

y consciously and actively working on it. Negative attitudes slow you down, but good ones are jet f

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

Professional from academic institutions, pharmaceutical industries, health care indust

uel, enhancing all you do.

Thinking that money is everything.
A great salary doesn’t e

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

quate to happiness. For most people – executive or staff – money means very little if you are trul

.

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

y unhappy. Job satisfaction is the number one reason people elect to find a new job. What gets you

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

Companies that provide selfless information through particip

up each day excited about going to work?

Take control of your career! If you don't, who else will?

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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