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Digg It - Accountability
One of my worst moments in a new job, the one
where I realized I wasn't in Kansas anymore, came after my
first business trip to the other coast. The admin who had
made my travel arrangements asked which hotel I wanted to
stay in. Of the two choices, one was 2 blocks
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
from the site,
the other was across town. Blithely, I chose the closer hotel.
Later that month, my manager hand delivered my expense reimbursement check, and a stern warning. I'd significantly exceeded the hotel per diem, and wasn't to do it again.
When I started to questi
Later that month, my manager hand delivered my expense reimbursement check, and a stern warning. I'd significantly exceeded the hotel per diem, and wasn't to do it again.
When I started to questi
; 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
on her, the response was "You
should have known it was above the range."
We both lost that day. I'm sure she had been called on the carpet for my lack of "accountability." I felt like I'd been set up.
The underlying problem is what I often hear labeled as a commun
We both lost that day. I'm sure she had been called on the carpet for my lack of "accountability." I felt like I'd been set up.
The underlying problem is what I often hear labeled as a commun
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ication problem. When I probe, I hear some version
of "everyone knows that" from managers, and
employees complain they never know when the axe is going
to fall.
Holding staff accountable is a crucial part of a manager's responsibility. But, any person, inclu
Holding staff accountable is a crucial part of a manager's responsibility. But, any person, inclu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ing
you and me, can be held accountable only when:
We know what is expected of us.
And, we believe we've agreed to the expectations.
As a manager, it's up to you to spell out the expectations. You need to let employees know, very explicitly, and in a w
As a manager, it's up to you to spell out the expectations. You need to let employees know, very explicitly, and in a w
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ay
they can hear, what your expectations are.
Build on where they are right now. Don't start at the skill level or level of understanding you think anyone in that position SHOULD have, but what they DO have.
If you have any question that they may not be getting what
Build on where they are right now. Don't start at the skill level or level of understanding you think anyone in that position SHOULD have, but what they DO have.
If you have any question that they may not be getting what
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
you are saying, go back, and check for understanding.
Then go for commitment. Just because they understand doesn't mean they agree to do it.
Understand is, "I know what's expected." Agree is "Yes, I will do it."
Make sure the agreement is explicit.
Only then will you
Then go for commitment. Just because they understand doesn't mean they agree to do it.
Understand is, "I know what's expected." Agree is "Yes, I will do it."
Make sure the agreement is explicit.
Only then will you
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
have both conditions for accountability.
It goes without saying you have the responsibility of being accountable yourself. At the management level, there are higher standards of accountability. No longer can you say I didn't know, or I didn't understand.
It's your wa
It goes without saying you have the responsibility of being accountable yourself. At the management level, there are higher standards of accountability. No longer can you say I didn't know, or I didn't understand.
It's your wa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ch. You're accountable for what's happening.
Which means, of course, that you need to hold your people accountable. There will come a day someone doesn't follow through, meet expectations, or deliver on a commitment.
Remember Rule #1: Behaviors that are rewarded are apt
Which means, of course, that you need to hold your people accountable. There will come a day someone doesn't follow through, meet expectations, or deliver on a commitment.
Remember Rule #1: Behaviors that are rewarded are apt
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
to be repeated.
And the Corollary for Rule #1: The best reward for "bad behavior" is to do nothing.
If you don't hold people accountable they'll quickly learn a lesson you don't want to teach: You don't really mean what you say. They can do what they want, or think nec
And the Corollary for Rule #1: The best reward for "bad behavior" is to do nothing.
If you don't hold people accountable they'll quickly learn a lesson you don't want to teach: You don't really mean what you say. They can do what they want, or think nec
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
essary.
Accountability
One of my worst moments in a new job, the one where I
realized I wasn't in Kansas anymore, came after my first
business trip to the other coast. The admin who had made
my travel arrangements asked which hotel I wanted to stay
in. Of the two choices
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
, one was 2 blocks from the site, the
other was across town. Blithely, I chose the closer hotel.
Later that month, my manager hand delivered my expense reimbursement check, and a stern warning. I'd significantly exceeded the hotel per diem, and wasn't to do it again.
When I
Later that month, my manager hand delivered my expense reimbursement check, and a stern warning. I'd significantly exceeded the hotel per diem, and wasn't to do it again.
When I
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
started to question her, the response was "You
should have known it was above the range."
We both lost that day. I'm sure she had been called on the carpet for my lack of "accountability." I felt like I'd been set up.
The underlying problem is what I often hear labeled a
We both lost that day. I'm sure she had been called on the carpet for my lack of "accountability." I felt like I'd been set up.
The underlying problem is what I often hear labeled a
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
s a
communication problem. When I probe, I hear some
version of "everyone knows that" from managers, and
employees complain they never know when the axe is going
to fall.
Holding staff accountable is a crucial part of a manager's responsibility. But, any person, inc
Holding staff accountable is a crucial part of a manager's responsibility. But, any person, inc
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
luding you and me, can
be held accountable only when:
We know what is expected of us.
And, we believe we've agreed to the expectations.
As a manager, it's up to you to spell out the expectations. You need to let employees know, very explicitly, and in a way th
As a manager, it's up to you to spell out the expectations. You need to let employees know, very explicitly, and in a way th
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
ey can hear, what your expectations are.
Build on where they are right now. Don't start at the skill level or level of understanding you think anyone in that position SHOULD have, but what they DO have.
If you have any question that they may not be getting what you
Build on where they are right now. Don't start at the skill level or level of understanding you think anyone in that position SHOULD have, but what they DO have.
If you have any question that they may not be getting what you
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
re saying, go back, and check for understanding.
Then go for commitment. Just because they understand doesn't mean they agree to do it.
Understand is, "I know what's expected." Agree is "Yes, I will do it."
Make sure the agreement is explicit.
Only then will you have bot
Then go for commitment. Just because they understand doesn't mean they agree to do it.
Understand is, "I know what's expected." Agree is "Yes, I will do it."
Make sure the agreement is explicit.
Only then will you have bot
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
h conditions for accountability.
It goes without saying you have the responsibility of being accountable yourself. At the management level, there are higher standards of accountability. No longer can you say I didn't know, or I didn't understand.
It's your watch. You
It goes without saying you have the responsibility of being accountable yourself. At the management level, there are higher standards of accountability. No longer can you say I didn't know, or I didn't understand.
It's your watch. You
.
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 accountable for what's happening.
Which means, of course, that you need to hold your people accountable. There will come a day someone doesn't follow through, meet expectations, or deliver on a commitment.
Remember Rule #1: Behaviors that are rewarded are apt to be
Which means, of course, that you need to hold your people accountable. There will come a day someone doesn't follow through, meet expectations, or deliver on a commitment.
Remember Rule #1: Behaviors that are rewarded are apt to be
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
repeated.
And the Corollary for Rule #1: The best reward for "bad behavior" is to do nothing.
If you don't hold people accountable they'll quickly learn a lesson you don't want to teach: You don't really mean what you say. They can do what they want, or think necessary
And the Corollary for Rule #1: The best reward for "bad behavior" is to do nothing.
If you don't hold people accountable they'll quickly learn a lesson you don't want to teach: You don't really mean what you say. They can do what they want, or think necessary
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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