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Advice You - Getting Fired - Facing the Facts - and a Possible Solution
Your boss called you in and said you are difficult to get along with and are causing problems not only for him but for other people i
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
n the office. He says you resist direction and don't take criticism well. And he says you're too critical of everybody else. But you
; 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
really think he's exaggerating. You think the people around you are more of a problem than you are, but on the other hand, your wife
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
r girlfriend says the same thing about you that your boss does. What do you do?
Listen to what these people are saying. There's an o
Listen to what these people are saying. There's an o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ld saying that if one person tells you that you're a horse, you can ignore it. If two people tell you, you might think about it. If 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
ree people tell you, buy a saddle. Your boss, your co-workers, and your wife are all telling you a similar story. It's time to listen
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
.
Why listen? Because if you don't, it sounds quite likely that you'll lose your job. And if you're doing this at home, and your wif
Why listen? Because if you don't, it sounds quite likely that you'll lose your job. And if you're doing this at home, and your wif
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
e is telling you about it, and you're ignoring her—which you have been so far—there's no way your marriage is fulfilling. And if you
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eep this up, the consequences will get worse and worse with time. You end up terminally alienating your children—if you have any—your
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
co-workers, your wife, pretty much everybody.
Time to listen. So what would listening look like?
Make an appointment with your bos
Time to listen. So what would listening look like?
Make an appointment with your bos
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. Tell him something like this:
"I've been thinking about what you said to me, and it has to be true. You're seeing these characteri
"I've been thinking about what you said to me, and it has to be true. You're seeing these characteri
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
stics in me, other people at work are, and my wife is, so it seems pretty unlikely that everybody is making this up. The only reason
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
I resisted you when you talked to me the other day is that I am literally blind to these behaviors in myself. I guess I've been actin
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
like this with people for so long that I just don't know that I'm doing it. So I want you to know two things: First, I really did no
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
t realize what I was doing; and second, I don't want to keep doing it."
"So I'm going to need some help here. If you're willing, I'd
"So I'm going to need some help here. If you're willing, I'd
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
like to meet with you periodically so you can point out some specific instances of my behaviors that would help me realize the overal
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
l pattern, so I can begin to change my behavior. I'm also going to be asking my wife to do this, so I can get all the feedback I can.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Would you be willing to do that?"
As you do this, you'll be demonstrating to your boss that you're serious about listening and abou
As you do this, you'll be demonstrating to your boss that you're serious about listening and abou
.
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
changing. Then do the same thing with your wife. Ask her to tell you about the things you're doing that are interfering with your re
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
lationship.
This is a great opportunity for you, not just to save your job but to enrich the rest of your life. Take advantage of it
This is a great opportunity for you, not just to save your job but to enrich the rest of your life. Take advantage of it
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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