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Main Subject - Presentations – Lessons Learned (at School)
In fact this article is a preparation for a next article on the same topic; one that is actually
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
still due.
We are to absorb so much knowledge that we tend to forget what we have learned when w
We are to absorb so much knowledge that we tend to forget what we have learned when w
; 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
e where still at school. Maybe you remember the time when you where asked to read out loud in fro
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nt of the class.
“Period.”
This period is key. Not only when reading a text, but also when pres
“Period.”
This period is key. Not only when reading a text, but also when pres
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nting the kind of material in front of a group of people. The technique is the same. You stop bec
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ause the action has ended end you are stepping into a new area. The period is there to signal thi
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 for you as a reader, but in the presentation you are to use this as a pause to check whether yo
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
ur public (readers) is still with you. It serves as a turning point (or a hinge) to turn the past
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in to the future. The period shows what is done. Up to the next phrase or picture, unless...
Unl
Unl
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
ess there is a problem. That is what you hope for giving a presentation (not always probably), bu
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t you would like to interact with the audience, because without feedback you cannot tell whether
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
the story has landed safely.
If nobody argues, then you can continue. The pause should also gi
If nobody argues, then you can continue. The pause should also gi
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
e you confidence knowing that what you are presenting is relevant and valuable and maybe passed t
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
o your audience.
Before we knew how to read properly, we forgot to wait for the traffic lights;
Before we knew how to read properly, we forgot to wait for the traffic lights;
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
we skipped the full stop and headed to the next sentence. But once we were confident in reading o
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
ut loud we stopped, waiting for the next action.
We tend to forget these simple things from the
We tend to forget these simple things from the
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
ast. Or maybe, when we forget to use a pause in the presentation, we are not confident enough.
P
P
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
erhaps that is the first step before presenting the material – to gain faith in what we will offe
.
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
r.
© 2006 Hans Bool
PS: The article that is still due is part two of – Models that color your p
© 2006 Hans Bool
PS: The article that is still due is part two of – Models that color your p
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
resentation. This has been quite a while. This brings me "lessons learnt" – do not pause too long
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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