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The butterflies started as you turned off the alarm this morning. Your appetite gone, you managed to swallow half a piece

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

of toast and a gulp of coffee before leaving for work. The commute seemed abnormally quick as you find yourself walking

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

Examples of combination products may in

in to the office. The cold sweat begins as your butterflies intensify. A co-worker notices your color and comments, “You

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

don’t look so good. Are you feeling okay?” You glance at your watch. The presentation will begin in ten minutes.

Of c

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

urse you’re not okay! Standing up and speaking in front of an audience is one of the most unnatural and truly frightenin

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

Combination pro

g experiences anyone will ever have. And now it is your turn.

The fear and discomfort that so many people associate with

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

public speaking is directly rooted in a lack of confidence and experience. As odd as it may seem, the only tried-and-tru

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

method for overcoming this fear and truly excelling at public speaking is to force yourself to do it repeatedly. Given t

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

he proper guidance and quality tips, your abilities will begin to improve. Increased ability coupled with increased exper

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

ience will build confidence, which will automatically increase the quality even more. From that point on, a snowball effe

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

t is inevitable.

Very few people have any interest at all in making their careers out of public speaking; however, even f

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

Following aspects would a

ewer people can expect to make it through their careers without some public speaking being required. Therefore, the basic

dd to the challenges in developing combination products:

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

concepts governing high-quality public speaking (and the “insider secrets” of people who have been there) should be of vi

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

tal interest to everyone.

Whether your audience fills a stadium, an auditorium or a boardroom, your goal should always be

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

to knock ‘em dead! Make sure no one ever leaves your speech or presentation with a question mark floating over their head

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

. Grab their attention at the first word, and never let it go. Leave them wanting more.

All of this is not only possibl

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, but also necessary if you wish to be effective when you open your mouth in front of two or more people. With your repu

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

ation on the line in front of an audience who may or may not care about your future, the need for quality is evident.

“An

.

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

audience will only remember one thing from a forgettable speech,” stated professional speech writer, Justin Lambert, “and

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

Companies that provide selfless information through particip

that is the speaker.” The importance of mastering this skill cannot be stressed enough.

Do your speeches knock ‘em dead

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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