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Main Subject - Control of the High Seas
Control the high seas and put yourself in charge.
No, not the high seas where swashbuckling Pirates roame
No, not the high seas where swashbuckling Pirates roame
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
d. These
HIGH C's are the way to "C SUCCESS"
COMMAND, COMMUNICATE, CONTROL, COMMIT
COMMA
COMMAND, COMMUNICATE, CONTROL, COMMIT
COMMA
; 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
ND
From birth until age 5 your parents tell you what to do.
From the age of 5 until 18 school te
From birth until age 5 your parents tell you what to do.
From the age of 5 until 18 school te
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ls you what to do.
From 18 to 22 you are told by college or the military what to do.
At that point s
From 18 to 22 you are told by college or the military what to do.
At that point s
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
omeone hands you a diploma or a discharge and says “Knock ‘em dead.”
You have never been taught to th
You have never been taught to th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nk for yourself and are conditioned to accept commands. You are not in control of your personal High Seas.
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
Your customers have received this same training.
You must command your customers. Tell them what you w
You must command your customers. Tell them what you w
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
nt them to do, they will do it. Instead of asking if they would like to see your product in action tell them to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
watch how simple it is to use.
COMMUNICATE
Webster’s Dictionary defines this as a verb that
COMMUNICATE
Webster’s Dictionary defines this as a verb that
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
means "to transfer information, thought or feeling so that it is satisfactorily received or understood."
T
T
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
here are two critical elements in that definition. The first tells us this is a verb. That indicates action. Th
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
e second uses the word “satisfactorily.” Effective communication requires you to make certain your customer un
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
erstands what you are saying.
It is equally important you understand your customer. Most misunderstandings
It is equally important you understand your customer. Most misunderstandings
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
are due to a lack of understanding. If that happens you will understand not making the deal.
CONTRO
CONTRO
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
Once again you must look at the definition as seen by Webster. “To regulate or have power over.” You mus
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
t regulate the events by learning the Road to the Sale and using it EVERY time. You must have control over 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
equence of events.
COMMIT
When you commit you are giving yourself over to something. A marriag
COMMIT
When you commit you are giving yourself over to something. A marriag
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e commitment is the giving of one life to another. A commitment to military service is a tour of duty for a set
.
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
amount of time.
During the sales process there are two commitments.
The first is your commitment to follow th
During the sales process there are two commitments.
The first is your commitment to follow th
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
e Road to the Sale.
The second happens when you ask your customer to commit to the completion of the sale.
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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