Just Answers - Writing and Speaking

How many times have you attended a public meeting where you did have something im

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

portant to say, but your fear of speaking in public kept you silent? You are not

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

Examples of combination products may in

alone in this regard because there are many people that have a great fear of publ

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

ic speaking. This is something that you do have to get used to. While you can eas

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

ly voice your opinion when you are in a small group of people whom you know well,

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

Combination pro

it is an entirely different situation when you are faced with speaking in front

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

of a group of strangers.

Even though public speaking is encouraged in school, on

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

ly a few students actually master the art. For one thing, you do have to like get

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

ing up in front of people to make a speech and you do need to have something wort

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

hwhile to say. You don't need to have a speech of three or four pages in most cir

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

cumstances, but you do need to have your thoughts well-organized so you can prese

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

Following aspects would a

nt what you have to say clearly. Stuttering and stammering only makes the listene

dd to the challenges in developing combination products:

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

s aware of the depths of your fear.

For many people, speaking in public is a nec

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

essary part of the job. In these cases, they may need to take classes to help the

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

m get over their shyness and get help with writing effective speeches. The writin

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

g does require a good grasp of the mechanics of English grammar so you don't make

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

Professional from academic institutions, pharmaceutical industries, health care indust

any faux pas that will spoil what you have to say. Even something as simple as an

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

introduction can turn into a joke, if you are unsure of your ability to speak. I

.

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

once attended a dinner where the speaker invited the minister to say grace by sa

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

Companies that provide selfless information through particip

ying. "I would like to call on our new pasture to ask the blessing for this meal.

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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