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Advice You - Responsibility + Sensitivity = Cooperative Authority
I was wondering if you can give me some advice. I work as a salesman and the company owner is a DICTATOR. Nothing 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
s accepted unless he personally approves it. That’s causing us big problems since we can’t sell on the spot. And if
; 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
the bargain isn’t completed at the moment, someone else will come and take it. Salesmen here don’t have any author
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ity to do anything. We get embarrassed in front of our clients. This is not professional. And if anyone talks about
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
this problem, the owner simply says, ‘It’s my money and not yours.’ What can I do to convince him? I would appreci
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
te your ideas about this.
***
Excellent question! Here’s my reply:
Sometimes business owners and department head
***
Excellent question! Here’s my reply:
Sometimes business owners and department head
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
s can be very restrictive. Sometimes it is due to insecurity, sometimes to past bad experiences, sometimes they are
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
simply unsure how to loosen the reins.
One course of action you can take is to give your company owner a proposal
One course of action you can take is to give your company owner a proposal
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
outlining the exact situations you are concerned about, and the parameters you would like to be able to approve on
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
the spot for your clients.
Make the guidelines conservative (at first) so you can be reasonably sure he will appr
Make the guidelines conservative (at first) so you can be reasonably sure he will appr
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ve your initial request. Such a proposal would get things going in the right direction and give you some (although
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
very limited) freedom.
Work within this approved range for a couple of weeks or months, still going back to him as
Work within this approved range for a couple of weeks or months, still going back to him as
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
agreed (and with a smile) for personal approval of everything else.
After some time has passed and he can see you
After some time has passed and he can see you
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
are following the rules, ask him to stretch the range just a bit more, and then a bit more, and then...you get the
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
idea.
The key is not to fight him, push him or even complain about him! Rather, work with him to create a clear p
The key is not to fight him, push him or even complain about him! Rather, work with him to create a clear p
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
otocol and build up his comfort and confidence first. Ask for more later.
EM-POWER-ment will come more quickly whe
EM-POWER-ment will come more quickly whe
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
n you demonstrate EMpathy as well as your eagerness for POWER.
Key Learning Point
Empowerment is essential for an
Key Learning Point
Empowerment is essential for an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
y growing business, and certainly for growing careers. To gain more authority, take more responsibility and show mo
.
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
re sensitivity. That’s being responsible, too.
Action Steps
If you are stuck in a situation where you have little
Action Steps
If you are stuck in a situation where you have little
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
leeway, finite freedom or just a dribble of discretion, use this approach to improve things s-l-o-w-l-y but surely
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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