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Digg It - Corporate Performance Evaluations
For many years, managers have been evaluated against standards of personal traits and work characteristics.
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
Typical trait-rating evaluation systems may list ten to fifteen personal characteristics, such as ability
; 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
to get along with people, leadership, analytical competence, judgment and initiative.
The list may also i
The list may also i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
clude such work- related characteristics as job knowledge, ability to carry through on assignments, product
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ion or cost results, or success in seeing that plans and instructions are carried out. However, until recen
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
years, personal traits have far outweighed work-related characteristics. On the basis of these standards,
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
the rater appraises subordinates, rating them from unacceptable to outstanding.
One practical problem of t
One practical problem 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 trait approach to appraisal is that, because trait evaluation cannot be objective, serious managers do n
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t wish to utilize their obviously subjective judgment on a matter as important as performance. And employee
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
s who receive less than the top rating almost invariably feel that they have been dealt with unfairly.
Tra
Tra
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t criteria are at best nebulous. Raters are dealing with a blunt tool, and subordinates are likely to be va
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
gue about what qualities they are being rated on. In the hands of most practitioners, it is a crude device,
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
and since raters are painfully aware of this, they are reluctant to use it in a manner that would damage t
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
e careers of their subordinates. One of the principal purposes of appraisal is to provide a basis upon whic
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
h to discuss performance and to plan for improvement. But trait evaluations provide few tangible things to
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
iscuss, little on which participants can agree as fact, and therefore little mutual understanding of what i
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
s required to obtain improvement.
As the deficiencies of trait rating have come to be recognized, a number
As the deficiencies of trait rating have come to be recognized, a number
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
of changes and additions have been introduced. Some are aimed at making the traits more comprehensible to
.
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
aters. Often, too, trait and work-quality forms are supplemented by open-ended evaluations in which, withou
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
t specific guidance, appraisers are asked to supply whatever evidence on performance they feel is pertinent
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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