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Advice You - If They Would Only Do It My Way
You have the perfect plan, you know how it will play out, everyone has a role and the outcome is assured. Then one or all of the people, or the characters in your play, don't follow your script and you don't get what you want in the way you want it.
This occurs all the time in fami
This occurs all the time in fami
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
lies, offices, business deals, friendships and teams. You, the director, KNOW how it should go if only everyone would do it YOUR way.
People use a variety of tactics to convince others to do things their way. Guilt, rewards, punishments, praise, begging, and so on.
Everything work
People use a variety of tactics to convince others to do things their way. Guilt, rewards, punishments, praise, begging, and so on.
Everything work
; 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
s sometimes, and you convince yourself that you have 'the power' to have people follow your plan and your script, except when your actors don't follow your plan, then the director (you) gets angry, frustrated, stressed, and lonely. Sometimes a director may tell himself that he isn't
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
good enough, that he doesn't don't know what he is doing, that he is a failure. He takes personal responsibility for the outcome by inflicting emotional pain on himself. Other times a director may blame everyone else. She may say that everyone else is the cause of the problem. She
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
had nothing to do with it. She had the perfect plan. Her plan was the best and if only everyone followed her way than there wouldn't be a problem.
Sometimes you may be treated as the actor in someone else's play. If you didn't agree to be a participant you may find yourself feeling
Sometimes you may be treated as the actor in someone else's play. If you didn't agree to be a participant you may find yourself feeling
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
resentful, put upon, victimized, threatened, and rebellious. Your behavior may be passive aggressive (smiling on the outside but sabotaging the production with your attitude or actions).
As leaders, managers, parents and team members it is important to realize that 1- everyone has
As leaders, managers, parents and team members it is important to realize that 1- everyone has
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
a choice, 2- everyone has their own plan, 3- everyone is the director of their own perception of the world.
The clash occurs when you expect everyone to follow your directions/orders/demands and they don't see the benefits or rational behind it or the "what is in it for me" factor.
The clash occurs when you expect everyone to follow your directions/orders/demands and they don't see the benefits or rational behind it or the "what is in it for me" factor.
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
We humans are self-centered, it is how we are. We have to decide to 'think' of others and not be so engrossed in our selves and our own affairs, easier said then done.
How can we get out of our self-centeredness and be better managers, leaders and parents? This is what this artic
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
le is all about.
Quotes
"When I get out of 'me' and find 'we' I become more successful"
"The one important thing I have learned over the years is the difference between taking one's work seriously and taking one's self seriously. The first is imperative and the second is disa
Quotes
"When I get out of 'me' and find 'we' I become more successful"
"The one important thing I have learned over the years is the difference between taking one's work seriously and taking one's self seriously. The first is imperative and the second is disa
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
strous".
~Margot Fonteyn
Self-interest is the enemy of all true affection.
~ Franklin D. Roosevelt
"It's hard to follow God closely when your eyes are focused on everyone else around you."
~Unknown
"When an organism begins to become self-centered, taking only in r
~Margot Fonteyn
Self-interest is the enemy of all true affection.
~ Franklin D. Roosevelt
"It's hard to follow God closely when your eyes are focused on everyone else around you."
~Unknown
"When an organism begins to become self-centered, taking only in r
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
gard to its own needs and ignoring those of its neighbor, we call it cancer."
~Ra Bonawitz
"Selfishness is not living as one wishes to live, it is asking others to live as one wishes to live."
~Oscar Wilde
Try-its:
To eradicate ourselves of self centeredness we have t
~Ra Bonawitz
"Selfishness is not living as one wishes to live, it is asking others to live as one wishes to live."
~Oscar Wilde
Try-its:
To eradicate ourselves of self centeredness we have 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
o first accept what we are powerless over:
1. Write a list of at least 25 people, places, things and situations that you are powerless over.
2. Review your list
3. Let the people, places, things and situations go. If you belong to a religious group give your list to your
1. Write a list of at least 25 people, places, things and situations that you are powerless over.
2. Review your list
3. Let the people, places, things and situations go. If you belong to a religious group give your list to your
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
God and let him handle the list for you.
For instance, I have no control of the situation when my son drives his car. He is 19. I'm not in the car with him. I can't navigate the road for him. I can't push cars out of the way if someone gets distracted and sways into his lane. I've
For instance, I have no control of the situation when my son drives his car. He is 19. I'm not in the car with him. I can't navigate the road for him. I can't push cars out of the way if someone gets distracted and sways into his lane. I've
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
handed that situation to a higher being, I know others who have faith knowing that all is well and let it go.
I do not have control over my clients. I'm not sitting in their offices 24/7 guiding their decisions. I've given all the information I can for them to make a decision. Ulti
I do not have control over my clients. I'm not sitting in their offices 24/7 guiding their decisions. I've given all the information I can for them to make a decision. Ulti
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
mately it is their decision based on all the information that they know (and I don't). I have to let it go.
Kick-butt actions:
Here are some questions to ask yourself when you find yourself trying to direct uncooperative people:
How important is it REALLY to have the person do
Kick-butt actions:
Here are some questions to ask yourself when you find yourself trying to direct uncooperative people:
How important is it REALLY to have the person do
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 task?
What are the rewards and consequences for the person? (Be clear and communicate those)
Can you, and more importantly, will you follow through on the rewards and consequences? If not, don't talk about them. If you don t follow through you will sabotage yoursel
What are the rewards and consequences for the person? (Be clear and communicate those)
Can you, and more importantly, will you follow through on the rewards and consequences? If not, don't talk about them. If you don t follow through you will sabotage yoursel
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
f by losing credibility.
Are there actions you want them to do OR do you want a specific outcome and the action doesn't really matter.
If friction arises be prepared to ask yourself:
What role did you play in this?
What was your responsibility?
What can you
Are there actions you want them to do OR do you want a specific outcome and the action doesn't really matter.
If friction arises be prepared to ask yourself:
What role did you play in this?
What was your responsibility?
What can you
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
do to make this situation right?
Do you need to apologize for your self centeredness or human frailty?
What will you do differently next time?
Remember we are all just players (actors) in this theatre of life. As a director/leader your job is to:
Inspire
Edu
Do you need to apologize for your self centeredness or human frailty?
What will you do differently next time?
Remember we are all just players (actors) in this theatre of life. As a director/leader your job is to:
Inspire
Edu
.
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
cate
Coach
Correct
Celebrate
Speak specifically regarding expectations and accountably.
If you do not have these conversations and chaos and friction will be the result.
Taking control and being in control are two different sides of the same coin. One
Coach
Correct
Celebrate
Speak specifically regarding expectations and accountably.
If you do not have these conversations and chaos and friction will be the result.
Taking control and being in control are two different sides of the same coin. One
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
is the beginnings of leadership the other can lead to the illusion that you ARE in control of people, places things and situations. Ultimately you are only in control of your own actions, thoughts, behaviors. So are you a director creating chaos or a leader inspiring a team effort
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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