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Advice You - Are You An Effective Communicator
The movement of information in any organization is from top-down, bottom-up, or department to department. You would be surprised at how much redundancy takes place in many organizations b
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
ecause the primary method of communication is:
1. You have to be in the right place at the right time.
2. You have to be high enough on the food chain.
3. You have to be in
1. You have to be in the right place at the right time.
2. You have to be high enough on the food chain.
3. You have to be in
; 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
the "in group" or
4. You have to fight for every scrap of information that you need to do your job right or better.
Again I ask you: How well can an employee do their job if they d
4. You have to fight for every scrap of information that you need to do your job right or better.
Again I ask you: How well can an employee do their job if they d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o not have the information they need to be effective?
I don't care what else you accomplish this year. If you can effectively address these three issues, you will be amazed at how much m
I don't care what else you accomplish this year. If you can effectively address these three issues, you will be amazed at how much m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ore profitable and competitive you can be in the market place.
Again, “Expecting different results from repeated behavior is a mild form of insanity.”
I am amazed at how frequently this
Again, “Expecting different results from repeated behavior is a mild form of insanity.”
I am amazed at how frequently this
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
quote has applied to me and various areas of my life. How about you? Does it apply to any area of your business today? A department? Policy? Procedure? You and your attitudes, expectatio
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
ns, or behavior?
To combat this habit of repeating mistakes in judgment, decisions, or actions, I have developed the following three questions that I ask myself every month, quarter, and
To combat this habit of repeating mistakes in judgment, decisions, or actions, I have developed the following three questions that I ask myself every month, quarter, and
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
year. I often share these questions with my audiences to get them thinking.
The three questions are:
1.What are you doing in your life, career, business, etc., that is working? Why
The three questions are:
1.What are you doing in your life, career, business, etc., that is working? Why
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is it working?
2.What are you doing in these same areas that is not working? Why isn’t it working?
3.What did you formerly do in these areas that used to work – that you have st
2.What are you doing in these same areas that is not working? Why isn’t it working?
3.What did you formerly do in these areas that used to work – that you have st
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
opped doing? When and why did you stop doing these things?
Answering these three critical questions can keep you traveling in the right direction in all areas of your business, career, a
Answering these three critical questions can keep you traveling in the right direction in all areas of your business, career, a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nd life if you will ask them often enough and pay close attention to the answers you get.
The purpose of this exercise is to ensure that you are:
1.Focusing on the right things in t
The purpose of this exercise is to ensure that you are:
1.Focusing on the right things in t
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
he right way
2.Letting go of old stuff that isn’t working
3.Reevaluating your career, business, and life from a past as well as a future orientation
4.Stretching yourself i
2.Letting go of old stuff that isn’t working
3.Reevaluating your career, business, and life from a past as well as a future orientation
4.Stretching yourself i
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
nto new areas of development
5.Experimenting with new strategies, attitudes, philosophies, feelings and skills
6.Reinventing yourself each year
7.Staying ahead of the curve
5.Experimenting with new strategies, attitudes, philosophies, feelings and skills
6.Reinventing yourself each year
7.Staying ahead of the curve
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
of relentless change
Many people are stuck in old ways of thinking, doing, and believing that just are not working for them anymore. Many managers, executives, and business owners are b
Many people are stuck in old ways of thinking, doing, and believing that just are not working for them anymore. Many managers, executives, and business owners are b
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
gged down in products, policies, and approaches that just are not working – and may never have – but they hold on to them for dear life, regardless. Why? Fear? Comfort? Indecision? Arroga
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
nce? Ignorance? Ego? Politics? It could be any or all of these or others.
Are you holding on to something that you need to let go of? For example:
1.A product that has outlived its purp
Are you holding on to something that you need to let go of? For example:
1.A product that has outlived its purp
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
ose or usefulness?
2.An unproductive or negative employee that is sabotaging the productivity of a department or the entire organization?
3.A policy that should have been change
2.An unproductive or negative employee that is sabotaging the productivity of a department or the entire organization?
3.A policy that should have been change
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d months or years ago?
4.An attitude or prejudice that is getting in the way of your personal success?
5.A management style that is counterproductive?
6.A procedure that is
4.An attitude or prejudice that is getting in the way of your personal success?
5.A management style that is counterproductive?
6.A procedure that is
.
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
redundant or counterproductive?
7.A habit pattern that is keeping you or your organization from improved effectiveness?
Why not spend some time on these final questions to see if y
7.A habit pattern that is keeping you or your organization from improved effectiveness?
Why not spend some time on these final questions to see if y
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
ou can uncover any areas that need modification or abandonment. If you feel really daring, why not put these questions to some of your employees or direct reports for their responses, too
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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