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Picture a man at the train station. I found this example on the Internet about the difference between data, information and knowledge. The train tables on the stat

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

ion show data about train schedules. The way the data is presented produces information informing users about the train departures, etc. Knowledge however is produced by t

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

Examples of combination products may in

e person in front of this schedule, knowing from experience that a certain train will arrive first, even though it left later. (a free translation of: www.hemmis.be/produc

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

ten/emaserver/emaserverkendata.htm)

“What do you want?” You’ve probably heard this question enough when searching for a career. Knowledge management starts when

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

ou have to find your first job and knowledge management will keep you company when moving forward with ever next step. For every question – what do I want - you will think

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

Combination pro

about; what do I have? What are my capabilities and competences?

Simple. There are many careers that are quite transparent; most medical careers, accounting and

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

o a lesser extent law. Many other careers are much more ambiguous. You may study engineering but favor a sales oriented job. It is easy if you know what you want, but when

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

you are in front of the gate of the university, you are not aware of the destination.

Knowledge management. Knowledge management is just taking care of this gap b

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

tween wish and reality, between the future and now. Knowledge management is about coming into action, because you know what you want (to achieve). For a company this is no

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

t really different although that there are many individuals in a group that is moving into same direction. Nobody really knows into what direction exactly and what knowled

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

e is therefore suitable.

Learning. Continuous learning seems one solution of bridging knowledge gaps. As long as you are eager to learn you will get there in the e

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

Following aspects would a

nd (and hopefully a bit sooner). But learning is not always the solution. First of all it is expensive. Secondly it requires a sequential process; first you learn than you

dd to the challenges in developing combination products:

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

do. First we go to school, and then we start working. Besides that, learning doesn’t always trigger new actions. And that is in the end what a company needs. Action.

O

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

n the job. On the job learning is a best practice that has proven itself worthy. One disadvantage of this style is that the knowledge gaining process is merely implic

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

t; you know what seems to work well, but your organization (you) doesn’t know why. And if you do not know why, you can’t judge either whether this – way – is applicable in

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

another environment.

Exchanging experiences. We all know the example of someone who joins a new organization, bringing in new knowledge. Valuable knowledge. But t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is new employee also needs to learn a lot about the way this organization functions. There is a mismatch. But that is not too much of a problem as long as there is a will

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

to cooperate and to share ideas how things were done on either side.

Bottom line. What matters therefore is not the amount of knowledge that people carry with them

.

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

but the "amount" of attitude in which they are willing to share this. Knowing this; If you are to manage knowledge you do not have to focus on knowledge as content, but m

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

Companies that provide selfless information through particip

ostly on the way this knowledge process takes place. Then you can also be confident that the man who is standing in front of the time tables is not alone.

© 2006 Hans Boo

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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