Just Answers - Computers and Technology

I am currently a Network Administrator that supports about 100 Se

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

rvers and 2000 Clients that has 8 years experience in Network Eng

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

Examples of combination products may in

ineering. This article explains why certifications really dont ma

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

ter.When I was in school all that my classmates talked about was

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

how you need this certification and that certification. Now that

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

Combination pro

am responsible for interviewing technicians I learned that they

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

really dont matter.

How many times did your Interviewer ask you

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

to see your actual certification. NEVER or almost NEVER. As long

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

s you know the material you can say you have any certification yo

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

u want. Since 95% of employers will never really check does it ma

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

e it right to lie about what certifications you really have. I wo

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

Following aspects would a

uld have to say YES and NO. It is not right to lie about what cer

dd to the challenges in developing combination products:

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

tifications you really have but on the other hand most companies

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

ave a non technical person interview you so all he wants to hear

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

is what are you CERTIFIED in.

My suggestion would be to just kno

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

the information that the job is for and now about saying you hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e all the certs. I still personally go and get all the certificat

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

ions but that is because I am required to show proof at my curren

.

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

position.

Thanks,

arsbargains

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

Companies that provide selfless information through particip

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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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Just Answers - Why Computer Certifications Really Don't Matter

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