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Summary - Penalty Phase - Getting Out of a Tough Moment
Arguments happen in every kind of relationship. They're just a part of life. Therefore, it's how we handle those moments that will d
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
efine the future of our relationships and how well they prosper and grow. I am sure that you've heard it said many times that in a h
; 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
eated moment you have to watch your words.
This is because words are very powerful and whatever you say can never be taken back. So
This is because words are very powerful and whatever you say can never be taken back. So
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
try to follow a few basic steps when a heated argument arises in your life. Step back and don't say a word until you have had a cha
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nce to process the situation. Try to really hear, not just listen to what the other person is saying. Even if you don't agree with t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hem, accept the fact that its how they feel and you will go a long way if you hear what they are saying. Your partner will begin to
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
feel validated and believe that you do care about their feelings.
Once you have listened to your partner's side, offer to sit down
Once you have listened to your partner's side, offer to sit down
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
to discuss the matter together. It's important to use an even tone, no matter how angry you may be. Once you are seated, start askin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
g questions about why your partner feels the way he/she does and listen to his/her response, again using an even tone. Be sincere. A
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
fter you have listened carefully to your partner’s side, explain how you feel without acting as though you are trying to win a debat
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e and annihilate them.
Ask your partner what he/she thinks a fair solution to the problem would be, and listen thoughtfully, contin
Ask your partner what he/she thinks a fair solution to the problem would be, and listen thoughtfully, contin
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
uing to look him/her in the eye. Tilting your head a bit to the side will give a non-verbal cue that you are even more interested in
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
what your partner has to say. Tell your partner that you value his/her opinion and offer what you think a good solution might be if
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
it should differ from his/hers, again using an even and sincere tone.
If there still remains a difference in opinion, try to come
If there still remains a difference in opinion, try to come
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
to some sort of compromise. You both may even need to walk away and think about some things for a while, agreeing that once you come
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
back together you will come to some sort of compromise. Don't let anything--children, phone calls or anything else-- get in the way
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
of coming back together for a resolution. If you let the problem go, it will only fester and explode into something bigger at a lat
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
er date. Resolve it now!
If the problem is too large for both of you to find a compromise, you may need to seek someone from the ou
If the problem is too large for both of you to find a compromise, you may need to seek someone from the ou
.
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
tside--a wise friend, a counselor at your church or a professional counselor--to help you to come to a resolution. Whatever you both
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
decide on, make sure that you follow through on the decision and not just brush it under the rug. Do what you say, say what you do!
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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