Main Subject - Business

Employers pay a high price for absenteeism, often more than they may realize, in terms of both fin

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

ancial and production losses and employee morale. Managers may view the tasks of finding a substit

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

Examples of combination products may in

ute employee as a short-term inconvenience; however, absenteeism frequently has more serious long-

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

term effects. Employers can, nevertheless, ensure that employees report in regularly and remain on

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

the job.

Before employers can determine the best way to combat absenteeism, they must identify t

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

Combination pro

he organizational and individual factors that contribute to the problem. Among the most common pot

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

ential problem areas employers need to explore are the following:

* Job satisfaction: Empl

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

oyees who like their job are more likely to come to work than those who find work unstimulating.

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

* Work attitude: Some employees come to work no matter how sick they feel, while others cal

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

l in sick no matter how well they feel.

* Company culture: If management's attitude is lax

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

and absenteeism is accepted as a normal practice, the organization's culture may have to be change

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

Following aspects would a

d before attendance can be improved.

* Excessive rates of sick leave: As some insurance co

dd to the challenges in developing combination products:

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

mpanies are now doing, employers need to monitor sick leave rates and reward employees who use few

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

er sick leaves.

Once you know the cause of absenteeism in your organization, it will become easy

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

for you to correct, or minimize, the problem. But you have got to do your homework.

Remember:<

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

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

Professional from academic institutions, pharmaceutical industries, health care indust

Gibbs, MSW

PERMISSION TO REPUBLISH: This article may be republished in ezines, newsle

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

tters, and on web sites provided attribution is provided to the author, and it appears with the in

.

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

cluded copyright, resource box and live web site link. Email notice of intent to publish is apprec

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

Companies that provide selfless information through particip

iated but not required. Mail to: eagibbs@ureach.com.

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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Main Subject - Reducing the High Cost of Absenteeism

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