Advice You - Business

THE PROBLEM:

- You've got an excellent system, and a fool-proof network, bu

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

t the problem is you're dealing with Harvard graduates not fools.

Today, ha

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

Examples of combination products may in

kers are not as sloppy as they were 10 even five years ago. They are educate

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

, by the best professors money can buy, and even though you have purchased s

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

me of the greatest software to battle them, they have an advantage. They thi

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

Combination pro

k outside the box, because they are human. You end up looking like the fool

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

ith a fool-proof network that doesn't work.

Don't get discouraged.

Here ar

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

the steps to make your network 100% secure.

-get a router if you don't hav

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

one

-talk to your IT department to make sure everything is in order

-get

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

*vulnerability assessment*

-make sure your antivirus is doing what you pai

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

for it to do

-read up on network security

All of these solutions are very

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

Following aspects would a

simple, so simple that most of us feel that we are already doing that.

SO d

dd to the challenges in developing combination products:

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

d these guys (click below) http://www.computerworld.com/governmenttopics/go

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

ernment/legalissues/story/0,10801,100239,00.html?source=NLT_SEC&nid=100239

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

f you need assistance with getting a Vulnerability Assessment you can email

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

e directly at nigel.williams@keeransystems.com or call 780.409.4222 x104

T

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

Professional from academic institutions, pharmaceutical industries, health care indust

e worst thing about getting hacked is you never see it coming on till your G

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

tting SUED for identity theft.

Nigel Williams Account Executive, Keeran Sy

.

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

tems

751 Scotia Place II
10060 Jasper Avenue
Edmonton AB Canada T

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

Companies that provide selfless information through particip

J 3R8
T 780.409.4222 x104
F 780.409.4223
www.keeransystems.co

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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Advice You - Your Business Is In Danger!

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