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Change and learning are highly correlated. Think about it:

We learn at school and we change. This is a gradual change. The pro

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

cess of learning makes that we open up and see new possibilities we previously not imagined. We continue to learn at high schoo

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

Examples of combination products may in

or university and there we change even more. The knowledge that we have gathered becomes a powerful source with which we can s

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

lect what we want.

And when we start to work we learn even more. During this process we grow older and we also acknowledge cer

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

ain limitations of our physical and mental powers. The process of learning and change continuously interact with each other. I

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

Combination pro

order to change we need to learn a new way of organizing or a new way of doing things and at the same time we have to learn th

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

t the old way is no longer suitable.

The younger you are the easier it is to change. This is why management is often eager to

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

ire relative young employees, because they do not have the burden of years of experience. The continuous investment in educatio

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

and learning changes you but at the same time it makes you more “rigid”. What you have learned has been valuable and will make

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

you proud.

Think of two professors at a university. The first supports the scientific management approach of change whereas th

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

other is specialized in the field of Organizational Learning, Like Peter Senge. Each with their own vision on change managemen

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

Following aspects would a

t. Do you think that these will ever change their views or paradigm? Equally, a Human Resource Management change approach will

dd to the challenges in developing combination products:

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

ot fit with the ideas of social and political power behind change. Leaders of either view will meet but never change from one

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

aradigm to another.

And so it is with learning and change in business or on a personal level. The more we have learned the les

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

we are able to change and to leave behind that precious treasure of knowledge that we have acquired.

So, if you are forced to

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

change or you want to change, first think about your background. How much do I value what I have done and more important: am I

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

Professional from academic institutions, pharmaceutical industries, health care indust

illing to give up this expertise in order to learn some new trick which I will not master for a long time?

That is the dilemma

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

with change. It is easy when you start from a Greenfield, but becomes hard when you have worked and invested so much and a simp

.

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

e new trend or fad just deflates it all.

Now, how does this affect you and what should you do? As a first step: just think abo

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

Companies that provide selfless information through particip

t all this. When dealing with change think about your background and whether it fits the situation you are in.

© 2007 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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