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Architecture is (normally) about buildings, cities and infrastructure (and the like). You can see it around you and everybody has an op

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

inion about it. You either like the style of that building or you don’t and all the nuances in between.

Between the Style of an orga

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

Examples of combination products may in

ization and the goal it pursues (although not everybody shares this approach of goal-oriented organizations) unfolds the area of systems.

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

Systems are a response to functional needs. A library provides the function to exhibit the public word. Accessibility is therefore an add

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

tional non-functional requirement. Once you or your organization is aware of the functional requirements it can start building Systems pr

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

Combination pro

viding the appropriate Construction.

This Function-and-Construction matching exists of three pairs, like the three pairs of wings of a bu

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

ilding :

The organization (human resources and organizational structure) that responds to the business process.
The in

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

ormation and functions that are accommodated with systems.

And the non-functional requirements that are solved with infrastruct

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

ure.

The metaphor of a building is not exactly appropriate, because between the different wings and each floor there are many

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

onnections...

In that way, the systems that companies use are accommodated on the middle floor and play a central role in the organizatio

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

. The structure of the systems exhibits much of the style and the business priorities.

This is a list of the systems of which one or more

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

Following aspects would a

could be present in your organization:

ERP – Enterprise Resource Planning. Systems that manage the internal operation.

dd to the challenges in developing combination products:

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

>SCM – Supply Chain Management. Dedicated to the management of information with third parties.

DMS – Document Management System.

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

Controlling the flow of documents.

CMS – Content Management System. Organize content that is to be shared by everyone.

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

>HRM – Human Resource Management. Systems that are to manage the human resources.

CMS – Contact Management System (e-mail respon

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

ers for example).

DWH – A Warehouse of corporate client and product data.

TCS – Telecom Systems. A wide area of system

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

Professional from academic institutions, pharmaceutical industries, health care indust

s that manage telephone traffic.

...etc.

If you think that this list represents the left or right wing on the seco

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

d floor, you can imagine that many powers influence this area. Every company, with whatever size, struggles with area. First because it is

.

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

prominent and eye-catching; everybody is dealing with it. Managing information systems is like managing politics; everybody has an opinio

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

Companies that provide selfless information through particip

about how it should be. The challenge is about managing new business and taking these systems with you...on your way...

© 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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