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These About Spain articles are not about tourism, although Spain is a beautiful country. They are meant to function as a reference for management and organization. Spain is

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

the decor to which common business issues are mirrored. Each company is struggling with certain issues, just in the same way that a government and the inhabitants of a country are

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

Examples of combination products may in

dealing with similar topics; distribution, priorities, communication, investments, infrastructure. (Corporate) Governance. And many others.

When you live and work in a foreign coun

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

ry you automatically compare that country with your own. During the process of adaptation you wonder about the differences and you will not only get to know a new country, the proce

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

ss also sheds some new lights on your own background.

One of the first (relevant) differences is the topic of infrastructure. Infrastructure is therefore important both for an orga

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

Combination pro

nization as for countries, because infrastructure is about quality. And when you examine the style of an organization you come across at least two possible ways of dealing with infr

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

structure.

But let’s first search for a definition. What are we talking about? Infrastructure is a very broad area; here are some definitions :

The basic physical syste

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

ms of a country's or community's population, including roads, utilities, water, sewage, etc. These systems are considered essential for enabling productivity in the economy. Develop

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

ing infrastructure often requires large initial investment, but the economies of scale tend to be significant. (www.investorwords.com)

As a Base; the stock of basi

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

facilities and capital equipment needed for the functioning of a country or area; "the industrial base of Japan" As a Substructure; the basic structure or features of a system or

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

organization (www.wordreference.com)

The definition I favor will include also elements like; education, safety, and other aspects of national governance.

Possible wa

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

Following aspects would a

ys of handling an organizational infrastructure are; pave the way (the infrastructure) once it is clear that you need it (1) or; prepare and plan the infrastructure up front before

dd to the challenges in developing combination products:

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

olling out new business developments.

The advantage is of the first is that it is the most flexible way; you only start investing in new roads, etc...once people really start using

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

them. “Let’s first check whether this road will really be used, before paving it...” This approach seems the preference way in Spain. Big real estate projects will start their dev

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

elopments at fallow areas. Later on, roads will be constructed or improved. Normally this wouldn’t be a problem. Yet, water is another element of infrastructure. Recently however, a

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

real-estate development project was cancelled because of insufficient water supplies. The infrastructure wasn't ready.

In the Netherlands, you wouldn’t easy encounter those kinds o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f problems; they prefer the other way, where infrastructure, care and governmental support are often leading (although there is a trend in the other direction).

The origin of this

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

infrastructural difference could be traced to the differences in the nature (and not the culture) of both countries. Holland is small and flat and therefore easily endowed with infr

.

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

structure. The Spanish countryside is extensive rough and uneven.

Yet the other cause is the cultural difference; The Netherlands have always had (like other northern countries) an

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

Companies that provide selfless information through particip

elevated collective sector, whereas Spain is a country with many individual ‘States’ struggling for more autonomy; and that doesn't benefit a "collective" support.

© 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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