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Useful Advices - Performance Appraisal Systems
Performance appraisal is a nine-step process. At the first stage, performance standards are established based
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
on job description and job specification. The standards should be clear, objective and incorporate all the fac
; 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
tors. The second stage is to inform these standards to all the employees including appraisers. The third stage
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
is following the instructions given for appraisal measurement of employee performance by the appraisers throug
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
h observation, interview, records and reports.
The fourth stage is finding out the influence of various inter
The fourth stage is finding out the influence of various inter
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
al and external factors on actual performance. The influence of these factors may be either inducing or hinder
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
ing the employee performance. The measured performance may be adjusted according to the influence of external
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
nd internal factors. The performance derived at this stage may be taken as actual performance. The fifth stage
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is comparing the actual performance with that of other employees and previous performance of the employee and
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
others. This gives an idea where the employee stands. If performance of all the employees is ranked either too
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
high or too low, there may be something wrong with the standards and job analysis.
The sixth stage is compar
The sixth stage is compar
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
ing the actual performance with the standard and finding out the deviations. Deviations may be positive or neg
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
tive. If employee performance is more than the standards, it is positive deviation and vice versa is negative
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
deviation. The seventh stage is communicating, the actual performance of the employee and other employees doin
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
the same job and discuss with him about the reasons for positive or negative deviations from the pre-set stan
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
dard as the case may be.
The eighth stage is suggesting necessary changes in standards, job analysis in inter
The eighth stage is suggesting necessary changes in standards, job analysis in inter
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
al and external environment. Lastly, there is follow up of performance appraisal report. This stage includes g
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
uiding, counseling, coaching and directing the employee or making arrangements for training and development of
.
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 employee in order to ensure improved performance. If the actual performance is very poor and beyond the sc
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
ope of improvement, it may be necessary to take steps for demotion, retrenchment or any other suitable measure
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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