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Summary - When Faced With Change, Do You Whine or Shine?
My yellow Labrador, Bo, hasn’t done well with the recent birth of my youngest son. Bo is five years old, but since we brought home the young babe, he has reverted to things he hadn’t do
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
ne since he was a puppy. He is peeing all over the house, tearing up furniture, and avoiding us as a sign of defiance.
It may seem silly for Bo to act this way, but think about how YO
It may seem silly for Bo to act this way, but think about how YO
; 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
U act when faced with change. Sure, you don’t start peeing everywhere or tearing up furniture, but do you lose control or resort to childish behaviors?
Change is constant and affects
Change is constant and affects
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
very area of your life. At work, in any given day, your products, customers, delivery schedules, or company’s policies could change. The way you react to these changes can either caus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e you to lose focus and sales, or it can propel you into greater success. It’s YOUR CHOICE!
Because fear is such a strong emotion, it creates an enormous amount of energy in a person.
Because fear is such a strong emotion, it creates an enormous amount of energy in a person.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Unfortunately, that energy tends to be negative and destructive. People dislike change because it puts them face-to-face with an even greater fear – the unknown. People who fear change
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
see themselves as the victim. They feel unprepared and inadequate to conquer whatever may come before them. They think they have lost control when, in reality, they have given it up t
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
rough their defeatist attitude.
An attitude like this is internally damaging to your focus and motivation and externally destructive throughout the company. When people are afraid, the
An attitude like this is internally damaging to your focus and motivation and externally destructive throughout the company. When people are afraid, the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y can act like a puppy that has just been yelled at, putting their tail between their legs and peeing themselves. They spew out negative comments to others, making others as afraid as
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
hey are.
While fear is natural, there is a way to manage it and even use it to your advantage. You can turn fear into positive energy by CHOOSING TO DO SO and by taking control of you
While fear is natural, there is a way to manage it and even use it to your advantage. You can turn fear into positive energy by CHOOSING TO DO SO and by taking control of you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r attitude and actions.
Be strong in your convictions.
Stop allowing others to determine your mood; you know the difference between right and wrong, good and bad. Choose to do
Be strong in your convictions.
Stop allowing others to determine your mood; you know the difference between right and wrong, good and bad. Choose to do
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
what is right and be proud of your decision. It may be difficult, but it makes all the difference in your personal success and the success of your company.
Be confident in your ab
Be confident in your ab
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
lities.
Trust yourself. When everybody in your company is thinking negative, it’s easy for doubt to creep in. Don’t let it! You do good work, you are an asset to the company – t
Trust yourself. When everybody in your company is thinking negative, it’s easy for doubt to creep in. Don’t let it! You do good work, you are an asset to the company – t
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
rust in your abilities and focus on the positive contributions that you make.
Be proud of the work that you do.
Work for yourself first. Strive to be the best for your reasons
Be proud of the work that you do.
Work for yourself first. Strive to be the best for your reasons
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
not someone else’s. Being accountable to yourself first will help you see the purpose and pride in ANY work that you do, even if the task seems menial. You won’t need validation from
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
everyone around you if you’re proud of who you are and what you do. With this independence, you’ll have the inner-confidence needed to weather any storm.
Learning to take control of
Learning to take control of
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
ourself in a changing situation will allow you to turn the energy that fear creates into POSITIVE energy. Although it may be easier to react negatively, challenge yourself to find the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
positive aspects and opportunities that lie within every change. When you see change as a challenge and an opportunity, you will get excited about it! Your energy and new and improved
.
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
ttitude will become contagious, quickly spreading throughout your company.
Changing your attitude will change your results. While others are still moaning and groaning, you’ll be on th
Changing your attitude will change your results. While others are still moaning and groaning, you’ll be on 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 phone with future customers, discussing new opportunities. Your choice to stay positive is all in your mind. You control your mind; you control the situation; you control the outcome
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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