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Useful Advices - Changing Conflict To Dialogue
Dialogue is a different kind of conversation. It's a way of exploring and understanding information and ideas. When practiced, it draws on and uses the wisdom of everyone involved.
It
It
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
is easier to create an argument than it is to create a dialogue. You do this when you have a different opinion than someone else about how to solve a problem, and you act as if there is
; 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
one correct answer and your task is find it.
As long as you believe that a single correct course of action exists, you debate the issue. You try to convince others that a particular pos
As long as you believe that a single correct course of action exists, you debate the issue. You try to convince others that a particular pos
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tion is correct. Someone wins and someone loses. Even when you believe that this is an outmoded way to solve problems, you continue to use it, because it is comfortable and familiar (Bus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ness as usual).
Dialogue, a technology for creating understanding in groups, is different. Dialogue is inclusive instead of exclusive. Dialogue is based upon the belief that there are m
Dialogue, a technology for creating understanding in groups, is different. Dialogue is inclusive instead of exclusive. Dialogue is based upon the belief that there are m
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ny ways of approaching any issue, and that no single one is correct.
The aim of Dialogue is to create a forum in which ideas can be explored, expanded, deepened and illuminated until ne
The aim of Dialogue is to create a forum in which ideas can be explored, expanded, deepened and illuminated until ne
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
meaning and understanding emerge. Instead of trying to create support for your own positions, when you engage in Dialogue you listen to and question others, attempting to deepen your un
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
derstanding of all of the information being presented.
The principles are simple, but not easy to put into practice. The challenge is to listen with care to each statement or question t
The principles are simple, but not easy to put into practice. The challenge is to listen with care to each statement or question t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
at is offered, and to respond in a way that deepens the investigation of the topic that is being explored.
You may then offer a statement of your own understanding, or ask a question to
You may then offer a statement of your own understanding, or ask a question to
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
focus the exploration in a new direction.
When everyone in the group agrees to practice the Dialogue process, learning increases dramatically. However, even if you're the only one inte
When everyone in the group agrees to practice the Dialogue process, learning increases dramatically. However, even if you're the only one inte
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ested in changing the conversation, you can make a good start at it by following these steps.
Being clear is more important than being right.
Instead of trying to prove that your idea
Being clear is more important than being right.
Instead of trying to prove that your idea
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
r position is correct, your task is to explain your beliefs carefully, so that others can understand them. As others come to understand your position, they may ask questions to clarify
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
heir understanding. Or they may also offer observations of their own that will allow you to better understand other aspects of your original ideas.
Eventually a shared understanding is
Eventually a shared understanding is
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
developed from many contributions, and the idea comes to belong to the entire group instead of to any single member of the group.
If it is necessary to make a decision about the issue b
If it is necessary to make a decision about the issue 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
eing addressed, it is done after the exploration is completed. Often such decisions emerge quickly and easily without any need to debate different positions. Everyone present has had the
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
opportunity to be heard and acknowledged and has made a contribution to the outcome. Commitment to such decisions is high (NOT just business as usual).
Exploring different perspectives
Exploring different perspectives
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
on the truth instead of arguing about which is correct can best be accomplished in a protected environment. It takes time to practice the skills of listening deeply and asking questions
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nstead of advocating your favorite positions.
Setting aside uninterrupted time to explore issues, without expecting to achieve any particular result, and agreeing to simple rules like a
Setting aside uninterrupted time to explore issues, without expecting to achieve any particular result, and agreeing to simple rules like a
.
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
lowing each speaker to complete a statement without interruption, are basic conditions necessary to begin the process. Learning to say "I wonder what would happen if..." instead of "I 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
nk you should..." is an important part of establishing an environment for Dialogue.
Trained professional facilitators can help you and your group learn how to implement these procedures
Trained professional facilitators can help you and your group learn how to implement these procedures
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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