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E-Folder - Politics at the Office - Friend or Foe?
With the 2008 elections quickly approaching, it seems that you just can't get away from the election coverage.
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
Everywhere you go, you'll hear something about the election. This includes your office. At the water coole
; 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
r, right before a meeting, even just chatting in the hallway, the subject is bound to come up. The question i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s this: Should you discuss politics in the office? Based on my experience, the quick answer is a definite
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>no. There are multiple reasons for this, but I'll focus on the main one which is described below.
While
While
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
it may seem harmless to discuss politics with your co-workers, you need to remember one important fact: Poli
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
tics is a very polarizing subject. People tend to be passionate about their political beliefs, and the
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
e strong feelings can bleed into their work interactions. It's unfortunate, but some people who don't agree w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ith your political beliefs can hold it against you at work, even if it has nothing to do with what you're work
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
ing on. At worst it can even cost you your job, if you happen to disagree with someone who has that kind of p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ull. At the very least it can strain relationships between yourself and your co-workers. Either way, I haven
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
't seen any good come out of it. Even people who are you're friends could become a problem, as you could touc
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
h on something very personal to them and not even know it.
What should you do if someone insists on talking a
What should you do if someone insists on talking a
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
bout politics? When this occurs, I either change the subject or extricate myself from the conversation. What
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
you don't want to do is just start agreeing to get out of the conversation. This just causes problems
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
and confusion, because this will only encourage them to continue on the subject. Also, they can use you as an
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
example when talking to other people. For example, they could say "..Yeah, well, I was talking to Kevin and
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he agrees with it as well.". Now you have another co-worker who is getting the wrong impression of you. Over
.
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
all, it just becomes a big mess that can cause massive problems for you and your co-workers.
In the end, it's
In the end, it's
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
your choice. Discuss politics in the office at your own risk, but be very aware of the possible consequences
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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