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After the performance of an employee is appraised, the superior should inform the employee about the level

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

of the employee’s performance, the reason for the need for improvement of performance, and the methods of

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

Examples of combination products may in

this improvement. The superior should counsel the employee about his performance and the methods of improv

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

ng it.

Counseling is a planned, systematic intervention in the life of an individual who is capable of ch

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

osing the goal and the direction of his own development. Thus the purpose of counseling is to help the emp

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

Combination pro

oyee to be aware of his own performance, his strengths and weaknesses, opportunities available for perform

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

nce development, and the threats in the form of technological change. Performance counseling can be done i

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

the form of performance interview by the superior.

The post-appraisal interview has been considered by m

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

st of the organizations, as well as employees, as the most essential part of any appraisal system. This in

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

erview provides the employee the feedback information. It also gives the appraiser an opportunity to expla

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

n to the employee his rating, as well as the traits and behavior he has taken into consideration for appra

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

Following aspects would a

sal.

It also gives the opportunity to the employee to explain his views about the rates, standards or goa

dd to the challenges in developing combination products:

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

s, rating scale, internal and external environment, or causes for a low level of performance. Further it h

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

lps both the parties to review standards, set new standards based on the reality factors, and helps the ap

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

raiser to offer suggestions coach the employee through his advancement.

Thus the post-appraisal interview

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

is designed to achieve certain objectives. The first objective is to let employees know where they stand.

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

Professional from academic institutions, pharmaceutical industries, health care indust

he second objective is to help employees do a better job by clarifying what is expected of them. The third

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

objective is to plan opportunities for development and growth. The fourth is to strengthen the superior- s

.

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

bordinate working relationships by developing a mutual agreement of goals. Last but not least, the post-ap

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

Companies that provide selfless information through particip

raisal interview provides an opportunity for employees to express themselves on performance-related issues

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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