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Advice You - Managing People; Feedback, the Breakfast of Champions
Athletes know that to improve they have to receive feedback on their performance. The feedback they receive may come by way of analysis of their performance on the track through a review of a video or analysis of their fitness, a
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
nalysis of their diet and metabolism or even analysis of their muscle fibre.
The more specific the feedback, the better the potential they have to improve their performance. Feedback is given on whether the diet needs changing,
The more specific the feedback, the better the potential they have to improve their performance. Feedback is given on whether the diet needs changing,
; 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
or the level of effort they expend in exercise, or the intensity of the exercise or the level of repetitions and so on.
Even more valuable feedback is given in that there are standards for every measurement. Standards are known
Even more valuable feedback is given in that there are standards for every measurement. Standards are known
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
for not only what times they should be running, but also what body fat level they should have, what percentage of fast twitch muscle is best for their event and other factors pertinent to their performance.
Standards are develop
Standards are develop
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ed from comparing world's best practice and determining the requirement for a particular athlete at their level of development or from empirical research carried out by the national sports institute.
Most of us recognise the fee
Most of us recognise the fee
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
back given to athletes as being necessary and extremely valuable to aid their performance development. The feedback is given as personal data. The data is specific. If data is not available, then controlled, documented observatio
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
ns are used. The feedback is related only to the goals of the athlete at the particular stage of their development.
If it is intuitively true to us that feedback to athletes that is specific, realistic, related to the goals of t
If it is intuitively true to us that feedback to athletes that is specific, realistic, related to the goals of t
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
he person, direct and non judgemental, then why do we, as managers, struggle to give feedback to subordinates?
Perhaps part of our inability to give feedback stems from our inability to receive feedback. To receive feedback we n
Perhaps part of our inability to give feedback stems from our inability to receive feedback. To receive feedback we n
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eed to follow a few simple rules.
In seeking feedback we need to be explicit. Make it clear what kind of feedback we are seeking. If necessary, indicate what kind we do not want to receive. The feedback from others is entirely f
In seeking feedback we need to be explicit. Make it clear what kind of feedback we are seeking. If necessary, indicate what kind we do not want to receive. The feedback from others is entirely f
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
or our benefit and if we do not indicate what we want we are unlikely to get it.
If we are receiving unsolicited feedback we still need to be specific about how we want to receive the feedback. We should not put up with poor fee
If we are receiving unsolicited feedback we still need to be specific about how we want to receive the feedback. We should not put up with poor fee
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
back technique such as "You did well" or "You did poorly". We need to ask, "What did I do well?", and "Why was it considered to be a job well done?", and "What is the impact on the organisation of doing the job the way I did it?"
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
, and "What could I do even better next time?"
We need to be aware. We need to notice our reactions, both intellectual and emotional. Particularly notice any reactions of rejection or censorship on our part. If the viewpoint fro
We need to be aware. We need to notice our reactions, both intellectual and emotional. Particularly notice any reactions of rejection or censorship on our part. If the viewpoint fro
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
m which the other is speaking is at variance with our own we should not dismiss it. Some people find it useful to partially dissociate or distance themselves in this situation and act as if they were witnessing feedback being giv
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
en to someone else.
We need to be silent and refrain from making a response other than to clarify the feedback; to not even begin to frame a response in our own mind until we have listened carefully to what has been said and hav
We need to be silent and refrain from making a response other than to clarify the feedback; to not even begin to frame a response in our own mind until we have listened carefully to what has been said and hav
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
e considered and clarified the implications; to not be distracted by the need to explain. If we really need to give an explanation do it later after the feedback session.
To give feedback we need to consider some simple rules fr
To give feedback we need to consider some simple rules fr
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
m the flip side of the coin.
Be realistic, directing our comments towards matters about which the person can do something. Ask people to do something different, not to be something different.
Be specific, accurate and timely, g
Be realistic, directing our comments towards matters about which the person can do something. Ask people to do something different, not to be something different.
Be specific, accurate and timely, g
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
iving sufficient data based information to pinpoint the areas to which we are referring. Allow the other person to have a clear idea of what is being said about those specific areas when it is fresh in their mind.
Be sensitive t
Be sensitive t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o the goals of the person and not just our goals. The work was produced for a specific purpose and we should be aware of that purpose and give our views accordingly.
Be descriptive and describe our views. Don't say what we think
Be descriptive and describe our views. Don't say what we think
.
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
the person should feel. Offer considered, rational views and allow the other person to accept or reject them as he or she sees fit.
Be consciously non-judgemental, offering our personal view and not acting as an authority.
Be
Be consciously non-judgemental, offering our personal view and not acting as an authority.
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
direct and say what we mean. Avoid wrapping it up in fancy words or abstract language.
If we take feedback seriously either giving or receiving, we may indeed find we have been sharing our bacon and eggs with a team of champions
If we take feedback seriously either giving or receiving, we may indeed find we have been sharing our bacon and eggs with a team of champions
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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