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References - Shifting the Conflict: 4 Steps to a Faster Resolution
Have you recently encountered conflict in your career or in your life? You are not alone. Conflict touches all of us at some point in
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
our lives. The question is, how do we resolve it?
Actually, resolving conflict is not all that hard when you look at it from a diffe
Actually, resolving conflict is not all that hard when you look at it from a diffe
; 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
ent point of view. In other words, when you look at trying to shift the conflict instead of trying to resolve the conflict, you will h
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ve greater success. Why? Because shifting the conflict comes from within you, and you can control you. Resolving a conflict involves
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
more than one person, meaning others you have no control over. In order to shift the conflict, you have to shift you. That sounds eas
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
enough, doesn't it?
There are four steps involved in shifting a conflict. Anyone who follows these steps will definitely have succes
There are four steps involved in shifting a conflict. Anyone who follows these steps will definitely have succes
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
s in coming to a final resolution. The hardest part is being honest with yourself. Can you do that? Sure you can!
1. Assess Your S
1. Assess Your S
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
tuation
In 4-5 sentences, describe what's going on. What's the big picture here? What is the energy surrounding it? Is it calm or w
In 4-5 sentences, describe what's going on. What's the big picture here? What is the energy surrounding it? Is it calm or w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ll all hell break loose at any moment? On a scale of 1-10, 1 being the worst situation ever and 10 being the best, how would you rate
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
his one?
2. What are the facts?
Leaving all emotion and opinion out of it, list all of the facts. Right now, it doesn't matter what
2. What are the facts?
Leaving all emotion and opinion out of it, list all of the facts. Right now, it doesn't matter what
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
you think about it or how you feel about it. All that matters is you know what really happened. Write a realistic summary of the fact
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
s. To help you in this process, answer these questions:
When did it start?
How did it start?
What was your part in this?<
When did it start?
How did it start?
What was your part in this?<
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
r>
Who else was involved?
How did you get to this point?
3. Look at it from the opposite point of view.
If the issue is with
How did you get to this point?
3. Look at it from the opposite point of view.
If the issue is with
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
another person or entity (company, organization, group, etc.), look at it from their side. As far as they are concerned, what happened
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
If no one else was involved, then look at it from the opposite side anyway. I know this is an extremely difficult step to take, but
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
his process gives you a new perspective, which is exactly what you need right now to shift the conflict.
4. Now, it's time for a solu
4. Now, it's time for a solu
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
tion.
Make a list of possible solutions. Try to think outside the box on this, because that may be where you'll come up with the perf
Make a list of possible solutions. Try to think outside the box on this, because that may be where you'll come up with the perf
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ct solution. Which solution makes the most sense? What are you willing to do to put this thing behind you? What is your next step?
.
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
ick a solution and move forward with it. Don't look back.
Remember, it's not about being right or wrong - it's about getting rid of w
Remember, it's not about being right or wrong - it's about getting rid of w
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
at's not working. Let go of the stress of the conflict - you don't need it. It's time to move on...
Copyright 2006 Wendi Moore-Buyss
Copyright 2006 Wendi Moore-Buyss
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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