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Digg It - Go Beyond Hearing and Listen, Listen, Listen
If we listened twice as much as we talked, we would be a lot further down the road to success. Peo
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
ple sometimes think I am very quiet when they first meet me. Those that know me are aware that I a
; 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
m quite the opposite. When I am in a setting where I do not know anyone, I spend my time listening
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to conversations. I pick up good information about most people at the event. Once I feel I have e
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nough to go on, I will put my hat in the ring and speak up. If most people did the same thing, the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y would learn how to participate in a conversation. Not only do you have to listen to conversation
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
s, you actually have to hear what they are saying. It is only through hearing that you will gain a
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
understanding. I am not saying you need to understand every conversation but you do need to under
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
stand enough to make an intelligent comment to get into the circle.
Another way to get into a con
Another way to get into a con
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
versation is to reiterate what you have just heard. I use, "did I hear you say . . . . .?” The res
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ponse is usually yes and then they continue to explain why they said it. This is your opportunity
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
to follow up with your comments. You must continue to listen and hear throughout any conversation
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
and only make a comment when you know exactly what you are talking about. I made a fatal error onc
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
e when someone was arguing a point and I agreed with them. They then asked me how I knew about the
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
subject. I was dumb-founded and could not answer as I was not really hearing what they said, I was
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
just listening in. I felt very foolish and now I make sure I hear the words and understand them b
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
efore agreeing. There is nothing like an embarrassing moment to straighten up your habits.
When y
When y
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ou attend events and spend your time adding to conversations, you are really taking in information
.
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
that will be valuable for you at another time. You will get to know the participants in the conve
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
rsation and perhaps even exchange business cards. You may also find that you have common interests
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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