Useful Advices - Business

In some cases, the performance appraisal processes are structured and formally sanctioned while in other cas

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

es they are an informal and essential part of daily activities. Performance refers to the extent of completi

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

n of the tasks that make up an individual's job. One type of performance appraisal is to evaluate employees

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

gainst standards of personal qualities and work profile. Usually trait rating evaluation systems may list ab

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ut ten to fifteen personal traits. These personal traits may include the ability to get along with people, a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

alytical competence, initiative, and leadership. The list may also include work related aspects such as job

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

knowledge, ability to follow assignments, production or cost results, and success in seeing that plans are b

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

ing carried out as expected. Many a times, employees may oppose this type of evaluation.

One realistic prob

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

em of the trait-oriented approach to appraisal is that trait evaluation cannot be objective. Serious and far

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

minded managers may not wish to be subjective when evaluating employees on matters as vital as performance.

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

o make matters worse, employees receiving a rating lower than what they feel is justified always feel that t

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

hey have been dealt with unfairly.

One widely used type of performance appraisal is the system of evaluatin

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

performance against the setting and accomplishing of objectives. Once a program of evaluating by objectives

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

which are achievable is operating, appraisal may become a fairly easy task. Supervisors determine how well

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

bjectives have been set and how well have employees performed against them. In some cases where performance

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

ppraisal by results has failed, the principal reason may be that managing by objectives was seen only as an

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

appraisal technique and in such a case it is most unlikely to succeed. Appraisal by objectives must be a way

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

of planning as well as a key to organizing, staffing, leading, and controlling. When performance appraisal i

.

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

done this way, the appraisal takes into consideration whether or not employees have established adequate bu

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

reasonably attainable objectives and how they have performed against them within a specified period of time

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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Useful Advices - Types Of Performance Appraisals

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