Actual - Writing and Speaking

Q: You have talked on your teleseminars about putting a teleseminar

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

audio onto a CD. Are you making your own CDs from your pc or do yo

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

Examples of combination products may in

outsource this?

A: A little background first. One of the great wa

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

s to create products out of your articles is to conduct a telesemin

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

r based on one or several of your articles. The teleseminar by itse

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

Combination pro

f is a product that you can then sell to your market.

You can also

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

take the audio of the teleseminar and burn it onto a CD and then yo

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

u have another product to sell to your market.

Now on to the quest

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

on. At the present time, I am making my own CDs right on my own lap

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

op actually. The volume of sales is getting to the point though whe

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

e I think my next move ist to invest in a small duplicating machine

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

Following aspects would a

and put my son in charge of this division. At some point I may have

dd to the challenges in developing combination products:

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

to outsource it further, but wouldn't that be a good problem to hav

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

?

For now, here are the steps I use -

1. Record the teleseminar u

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

sing a free service like freeconferencing.lifeoffice.com

2. Downlo

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

d the mp3 onto my computer.

3. Edit the mp3 and add intro and exit

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

Professional from academic institutions, pharmaceutical industries, health care indust

music.

4. Import the audio into my iTunes.

5. Burn the mp3 to a C

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

.

6. Slap on a nice label.

That's really all there is to it. It's

.

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

a great way to get started, especially on a shoe-string budget. It'

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

Companies that provide selfless information through particip

really a nice 360 process and I'll go into more in another article

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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