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Main Subject - Don't Pollute Those Around You
There is a great deal of wisdom in what my mother told me, "If you can't say anything nice don't say anything at all." Recently
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
I was in the front row (which by the way is known as the millionaire's row because winners don't hide at the back) of a company t
; 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
aining event. A colleague of mine was not impressed with one of the trainers. She could not or would not contain her disdain and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
roceeded to make a series of noises to express her lack of approval for the presenter's style and delivery. The noises ranged fro
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
; exaggerated sighs, low groans and mumbled words.
Normally I would have ignored the rudeness and written the person off as bein
Normally I would have ignored the rudeness and written the person off as bein
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
g discourteous and immature but my concern was for the young woman who sat between us. It was her first time at this kind of even
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
and I didn't want it tainted by the rude person's antics. When there was a break in the day's training I asked the demonstrative
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
woman to step outside with me. I told her I could appreciate her negative opinion of the presenter's style and admitted that ther
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
were others who might have delivered the material in a more appealing fashion. When I told her my concern was that the new girl
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
might end up adopting her negative opinion of the presenter and miss out on the important content of the presentation. She looked
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
very sheepish as she admitted that wasn't being fair to young woman.
I'm reminded of something I have to caution my wife with in
I'm reminded of something I have to caution my wife with in
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
certain situations, "Inside voice, outside voice." Even the most positive of us entertains a negative thought from time to time.
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
t is your responsibility to determine which thoughts get shared out loud and which remain silent. When you put down others or exp
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
ress your negative judgments to those around you, you are polluting the room. At best you will contaminate the others and elimina
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 any value they may have gotten from the presenter. At worst you will have portrayed yourself as someone who is negative, judgme
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
tal and inconsiderate, not the traits of a winner.
If you ever find yourself in a training or educational event and start to thi
If you ever find yourself in a training or educational event and start to thi
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
k the presenter or instructor is inept, catch yourself. Instead of looking for where he or she is not reaching your expectations
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
start imaging yourself up on stage. Ask yourself, "How would I present this information? How would I do a better job?" If you don
.
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
t like the way trainings are done then become a trainer and do a better job. It is your responsibility to get as much out of a tr
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
ining as possible. It is also your job to make every event as positive as possible. It will be good for you and your organization
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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