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So many times in seminars I hear people say that the main goal for them is “to get through the day wi

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

thout someone yelling at me.”

I propose a new day for you with a new skill set. The proactive “I wil

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

Examples of combination products may in

l service you before you start yelling” skill set.

So, what do you do now?

1st is identify your wea

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

est area in your skill set. Is it listening, communicating or even impatience with customers? Once yo

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

u have decided which it is we need to embark on a course of correcting it. The thing to remember is y

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

Combination pro

u did not build the skills you have now in a day, and it will take a little time to get a new skill s

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

et in place. Just work at it day by day, and suddenly you will find yourself with new daily skills, n

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

t old worn out skills.

Once you have decided which skill you want to improve,you'll need to find a s

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

ource to study and learn from. It can come from the library, several adult development sites, you nam

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

it. Just Google your weak spot and wala, you now have pages and pages to choose from.

Next. Learn.

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

Copy. Study. Practice. Repeat. Learn. Copy. Study. Practice. Repeat. Again and again. Humans love rep

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

Following aspects would a

etition. Don’t believe me; try stopping your favorite hobby. Why do we read a book we love over and o

dd to the challenges in developing combination products:

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

er? If we didn’t love repetition, why do we purchase DVDs? You’ve already seen it right?It’s because

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

we learn and assimilate information this way.

Next, practice the language you would like to use. Scr

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

pt it out. If you are hearing the same type of complaints over and over, script out the complaint and

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

several responses you would like to use. You might be surprised at the answer you have been giving.

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

Professional from academic institutions, pharmaceutical industries, health care indust

nce you have seen it in print and then said it out loud, you may not like it. Don’t be afraid to chan

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

ge it up a little. Just get it down on paper. And say it again and again.

By now, you can almost fee

.

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

the confidence growing in your responses and yourself!

You will feel ready to handle most anything.

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

Companies that provide selfless information through particip

And you’ll find that customers will respond to your new found skills and confidence with compliments

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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