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Main Subject - All Change Please
Restructuring, redundancy, redeployment; mergers, acquisitions; downsizing, upsizing, expansion, streamlining; cost cutting, cost savings, cost justif
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
ications.
All the above signal change, and if you're like most people, change might just sit a bit uneasily with you. This is true whether you're cha
All the above signal change, and if you're like most people, change might just sit a bit uneasily with you. This is true whether you're cha
; 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
nging where your desk is positioned or changing jobs. It's very rare to have no reaction to change.
Though, of course, some people thrive on it and a
Though, of course, some people thrive on it and a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ctually have a hard time maintaining any kind of status quo.
In this day and age of working practises, it's unusual to exist with no change in your j
In this day and age of working practises, it's unusual to exist with no change in your j
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
b or working environment. Yes, some people still do stay in one job for life, but that is no longer the norm as it was just a decade ago. People chang
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e jobs and even careers at a remarkable pace these days and yet, somehow, their emotional reaction to change hasn’t caught up with what they're actual
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
ly doing.
Now all the psychologists will tell you that even when you're doing something by choice and that will supposedly make your life better (lik
Now all the psychologists will tell you that even when you're doing something by choice and that will supposedly make your life better (lik
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
changing job or moving house), you will still experience stress. So imagine how stressful things can be if you didn't choose the change yourself; if
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
it was imposed on you.
In the workplace you can almost be guaranteed that in most cases, one change after the other will indeed be imposed, not chose
In the workplace you can almost be guaranteed that in most cases, one change after the other will indeed be imposed, not chose
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
n. When this happens, there's all kinds of resentments and disgruntled feelings that sweep around the office like flu: Why weren't we consulted? It's
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ot going to work anyway. I could do a better job than them planning this move. Etc.
If this sounds familiar and is something you have in the past, or
If this sounds familiar and is something you have in the past, or
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
are going through now, we have a couple of challenging tips that might make it a whole lot more manageable.
First, you could decide to choose to go
First, you could decide to choose to go
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
along with it all without a single gripe. 'What?', we hear you shout. Yes, you could take a look at whatever situation you find yourself in and choose
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
something to agree with about the change. It doesn't have to be something major, or even the key reason the change is happening; it should, however,
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
e something you genuinely think is good. Sometimes (more often than not) we get so focused on the downside of change that we overlook the fact that th
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
ere may very well be lots of upsides at the same time.
Second, initiate some change yourself. This, too, can be quite small, but its affect can be fa
Second, initiate some change yourself. This, too, can be quite small, but its affect can be fa
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
r reaching. The reason for this is the difference between passive choosing and active choosing. When change is imposed on us, we can go quite passive,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
either through frustration, anger, fear, anxiety or a combination of all of those feelings.
Once we become active, we create more energy, we get thin
Once we become active, we create more energy, we get thin
.
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
gs moving, we feel less a victim to change than an active participant.
Finally, the thing about being actively involved in change is that you get to
Finally, the thing about being actively involved in change is that you get to
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
stay in charge of some of it, however minor a role, and you are seen to be someone who makes things happen.
Not a bad thing in an ever changing world
Not a bad thing in an ever changing world
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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