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E-Folder - Managing Your Team (Part 10) - Why Assumptions Are Dangerous
From the day we are born, we begin our own unique development process which can be influenced by our parents, our siblings, our teachers, our friends, our church, our faith, our readings, society and so on. Part of this
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
unique development process is establishing our own set of values that stay with us through life.
These values drive our belief system which, in turn, influence our behaviours and actions.
Having a set of values is grea
These values drive our belief system which, in turn, influence our behaviours and actions.
Having a set of values is grea
; 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
t. What's not so great is when we cannot accept a differing set of values belonging to someone else.
Take a moment, think of your team members or others with whom you are in regular contact. Have there been occasions w
Take a moment, think of your team members or others with whom you are in regular contact. Have there been occasions w
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hen you haven't quite understood or totally disagreed with their views or their behaviour?
what was your immediate reaction?
Did you seek clarification, did you try to understand, or did you assume, based on yo
what was your immediate reaction?
Did you seek clarification, did you try to understand, or did you assume, based on yo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ur values and beliefs, that their behaviour was due to................?
The danger with this assumption, any assumption, is that it can lead to bad feeling, resentment, even hostility when we start to voice these assump
The danger with this assumption, any assumption, is that it can lead to bad feeling, resentment, even hostility when we start to voice these assump
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tions, these attributes that we have decided to give someone.
Listen, we can all be guilty of this from time to time. Think about it. Isn't a lot easier and more comfortable to rationalise someone's actions and bring
Listen, we can all be guilty of this from time to time. Think about it. Isn't a lot easier and more comfortable to rationalise someone's actions and bring
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
some sort of meaning to their behaviours.
The twist is that it is also human nature to get our backs up when somebody does exactly the same to us...
I know why you did that
I know what ma
The twist is that it is also human nature to get our backs up when somebody does exactly the same to us...
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
kes you tick
You never agreed to it in the first place
We all know what you think
You're just opting for the easy way out
The harsh reality is that this behavi
The harsh reality is that this behavi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
our, assuming that which is not true, is an excuse for not making the effort, for not working at understanding, for not seeking the real explanation.
Now, this is bad enough if left unchecked within the team. Unfortuna
Now, this is bad enough if left unchecked within the team. Unfortuna
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
tely, there can also be a tendency to make assumptions about individuals, even groups outside the team.
They don't want our inputs
You know they have it in for us
That lot, what
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
a waste of space
He'll never support us in a month of Sundays
They're just waiting for something to go wrong
Why is this a problem? Bottom line? It will almost definitely lea
Why is this a problem? Bottom line? It will almost definitely lea
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
d to the wrong decisions being made, reaching conclusions and developing actions which are certain to deliver less than favourable results.
What's a team leader to do?
Well, by now, you'll know that I am going t
What's a team leader to do?
Well, by now, you'll know that I am going t
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
o reiterate the need for well established ground rules, for following a systematic approach, for ensuring statements are based on facts and are well supported. Post the ground rules on the wall in the team sessions. Remi
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
nd all participants that these were agreed.
If a comment is made by one team member to another, you can rest assured that the recipient and the rest of the team will be waiting with bated breath to see what your reactio
If a comment is made by one team member to another, you can rest assured that the recipient and the rest of the team will be waiting with bated breath to see what your reactio
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
n is going to be. Ignoring it is not the right behaviour - think of the messages you send to the team - the agreed ground rules mean nothing, zilch, nada. And, as it happens You really don't care what they think of ea
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
ch other.
Being constructive, confronting the issue and not the person...
"Pete, if I heard it correctly, Willy has just said that your behaviour shows you don't care whether we succeed or not. How would you des
Being constructive, confronting the issue and not the person...
"Pete, if I heard it correctly, Willy has just said that your behaviour shows you don't care whether we succeed or not. How would you des
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
cribe your behaviour?"
shows the individuals have and will be listened to and, of course, the success of the team is important. This success can only be realised if everyone is on board and willing to head in the s
shows the individuals have and will be listened to and, of course, the success of the team is important. This success can only be realised if everyone is on board and willing to head in the s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ame direction.
The team member's suggestions as to why a different group did what they did may well be close to the mark, but how do you, the team, know that? Confirm it, make sure before acting or reacting. Again, th
The team member's suggestions as to why a different group did what they did may well be close to the mark, but how do you, the team, know that? Confirm it, make sure before acting or reacting. Again, 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
e team's success may depend on it.
"How does that explain why they took that action? How can we confirm that? What data can we get to show that this is not just an assumption or someone's opinion."
That conclud
"How does that explain why they took that action? How can we confirm that? What data can we get to show that this is not just an assumption or someone's opinion."
That conclud
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
es this 10 part mini series on Managing Your Team. Even if you have taken only one thing, embraced only one idea, it has been worthwhile publishing these articles.
There are other Team Building articles in the pipeline.
There are other Team Building articles in the pipeline.
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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