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Digg It - 3 Lessons About Meetings from the Forest
Here are three lessons about meetings that came from a walk through the forest.
1) Giant Sequoias
These marvelous trees are a
1) Giant Sequoias
These marvelous trees are a
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
living example that some things take time.
True, we need to work with a sense of urgency. We need to do more with less. We ne
True, we need to work with a sense of urgency. We need to do more with less. We ne
; 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
ed to move faster than the speed of chaos.
And we also need to be appropriate.
Rushing through some issues can produce false
And we also need to be appropriate.
Rushing through some issues can produce false
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
solutions.
For example, a group slams together an annual plan, only to find that the plan ignores real market conditions, orga
For example, a group slams together an annual plan, only to find that the plan ignores real market conditions, orga
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nizational limitations, and individual support. The result is a document that no one uses.
For example, a powerful group makes
For example, a powerful group makes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a decision without listening to other people's ideas. And then a bad situation becomes worse. In fact, sometimes the neglected
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
side retaliates with such force that the original group loses status.
Better: Take time to make sure that all considerations
Better: Take time to make sure that all considerations
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
are included in plans and decisions. If you are planning a meeting to resolve a major issues, hire a skilled facilitator to hel
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
p you obtain a result that lasts.
2) A Bear Cub
This cub behaved like a goofy toddler while mama bear went about her business
2) A Bear Cub
This cub behaved like a goofy toddler while mama bear went about her business
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
collecting groceries in a supermarket. The cub climbed on logs, fell off rocks, and dropped things on mama. And during all of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
this play, mama bear just kept working, munching plants, gathering nourishment.
That is, she kept eating until the cub ran tow
That is, she kept eating until the cub ran tow
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
ard me. Then mama bear looked up, growled, and chased after the cub. (I'll assume that's what she did, because I ran away when
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
Mama Bear growled.)
What's the point?
Sometimes we need to allow an appropriate amount of disorder because it's part of growt
What's the point?
Sometimes we need to allow an appropriate amount of disorder because it's part of growt
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
h. It's part of letting people explore. It's part of letting people be themselves. Of course, when threats appear, then we shou
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
ld take charge. And we may only need to growl to restore order.
3) Mustang Clover
In the spring, the Sierra Nevada mountains
3) Mustang Clover
In the spring, the Sierra Nevada mountains
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
are covered with patches of Mustang Clover. These small flowers (typically, less than half an inch across) look like simple sma
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
ll pink dots as you walk past them. But if you pause and look closely, you will discover a masterpiece of complex beauty.
The
The
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
point: Are you pausing to notice important details? Some may be merely enjoyable reminders of how wonderful life can be. Others
.
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
may be essential indicators about the health of your business.
By the way, you can view photos of a Giant Sequoia, a bear cub
By the way, you can view photos of a Giant Sequoia, a bear cub
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
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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