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Digg It - The 7 Rules of Upward Communication
Bit by bit, your workplace is changing.
As the old industries disappear, and along with them, control styles of manageme
As the old industries disappear, and along with them, control styles of manageme
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
nt, so new structures and new systems are taking their place.
Where once the manager sat atop the pyramid, and issued co
Where once the manager sat atop the pyramid, and issued co
; 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
mands to the team below, today there is every chance that it is the team that sits astride the pyramid and issues informa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ion to the manager below.
Today, it is teams that have the information and knowledge. It is the teams that know how the
Today, it is teams that have the information and knowledge. It is the teams that know how the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
business's customers feel. And teams that can manage by themselves.
All this means a re-think on the traditional nature
All this means a re-think on the traditional nature
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
f communication.
Where once the predominant flow of communication was from the top downwards, in a one-way flow, in toda
Where once the predominant flow of communication was from the top downwards, in a one-way flow, in toda
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 information age, communication is multi-directional and purposeful. It goes anywhere and goes where it is needed.
Tha
Tha
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
t can be up or down, horizontally across, and all ways diagonally.
And one of the key skills of this kind of communicati
And one of the key skills of this kind of communicati
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n is Upward Reporting.
This skill requires: knowing how to get and keep the ear of your boss; reporting in a timely fash
This skill requires: knowing how to get and keep the ear of your boss; reporting in a timely fash
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
on; knowing what he or she needs to hear; being short and accurate; balancing problems with solutions; and being willing
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o be questioned and cross-examined.
To illustrate Upward Reporting, here is a set of rules posted by a manager to a self
To illustrate Upward Reporting, here is a set of rules posted by a manager to a self
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
-managing team on how she wants to be kept informed.
"When you report up the way, please remember...
Rule 1: Kee
"When you report up the way, please remember...
Rule 1: Kee
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
me regularly informed; I hate nasty surprises.
Rule 2: Don't deadline me. I know it's been done to you, but ple
Rule 2: Don't deadline me. I know it's been done to you, but ple
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
se give me some time to think.
Rule 3: Only bring matters that you really can't resolve. Anything else will just
Rule 3: Only bring matters that you really can't resolve. Anything else will just
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
go back to you.
Rule 4: Don't leave out the bad points because you want to look good: tell me it all.
Rule 5
Rule 4: Don't leave out the bad points because you want to look good: tell me it all.
Rule 5
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
Give me at least three options for every problem. I prefer to choose and it's quicker.
Rule 6: Do your home
Rule 6: Do your home
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
ork before you come; I don't want you to have to go away and look something up.
Rule 7: Remember that this is how
Rule 7: Remember that this is how
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
you'll want your staff to report to you when you're in my position!"
Communication is, and always has been, the glue th
Communication is, and always has been, the glue th
.
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
t binds an organization together. Just because the predominant direction of that communication may have shifted from top-
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
own to bottom-up, doesn't mean it is any less important. Learn how to properly report up and you'll master the new regime
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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