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Digg It - The ERP Implementation And Solving Some Issues Down The Road
Your business is constantly changing. We hear this once in a while, so it sounds familiar and
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
probably true. But if you are to remember those special periods in which the world seemed al
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
l different, you will notice that it takes a moment to find such a period, not too long ago.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
The moments you have traced were probably those you had bought something new; such as a video
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
recorder, that made it possible to save precious moments. That is one example, but think for
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
yourself the devices and products you have bought, but that did not always change your life.
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
An ERP implementation may fall in this category. Companies that buy products hoping for a si
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
tuation to change will often get disappointed. Unfortunately this becomes clear after a long
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
period where the system is plugged in the operation.
One of the problems I hear about when o
One of the problems I hear about when o
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
ganization deal with such an implementation is that there is a mismatch of competences. Compe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tences in the sense of who is doing what. Normally this involves some business units and a ce
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ntral department. The business unit is free up to a certain (but often unclear) point to inve
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t in own solutions and in new product developments. As more units follow this path, there co
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
mes a point where this freedom will give a out of proportion amount of extra work in the cent
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ral administration departments. Business criteria for one department are often out of sync w
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
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
th criteria for other kind of departments. This is something your organization should be awar
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e of.
It is however also logical that new investment take place and ERP systems are sound in
It is however also logical that new investment take place and ERP systems are sound in
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
vestment choices.
What your organization should not forget is that the previous issue still
What your organization should not forget is that the previous issue still
.
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
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
eeds to be solved. And a system may help, but as you know from your own experience with your
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
video camera; you often forget to bring it when there is an important event.
© 2006 Hans Boo
© 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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