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For a long time, companies used employee time clocks to keep track of how many hours each employee worked each week. Each empl

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

oyee had their own punch card, which they inserted into the time clock so the time could be stamped on it. Even though technol

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

Examples of combination products may in

ogy has caught up with the time clock, it is still one of the best ways available of keeping track of the hours an employee wor

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

ks, and transferring that information across to payroll so that the employee is paid correctly.

Nowadays, it's more likely tha

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

t an employee will have his own plastic swipe card, and he will swipe this through a slot on the time clock to record the time

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

Combination pro

he starts and finishes. This information is either transferred immediately to the computers in payroll, or is downloaded at re

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

gular intervals so that the data can be accessed by payroll. This data can then be uploaded straight into a pay system, or pri

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

nted out on a spreadsheet for checking and entry into the pay system. Overall this system is much more efficient and reduces t

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

he possibility of human error.

It's a good idea to locate the time clock somewhere convenient, such as near a main entrance or

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

in a room set aside for taking breaks. If an employee isn't paid for lunch breaks, they need to swipe their card at the start

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

and end of lunch. It must be clearly stated that it's against company policy for any employee to swipe a card on behalf of ano

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

Following aspects would a

ther employee. In other words, it's against the rules to clock in or out for another employee. Using another person's time ca

dd to the challenges in developing combination products:

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

rd is nothing less than fraud, and is grounds for instant dismissal of both the employees concerned. Naturally it's important

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

to make sure the fraud wasn't committed on purpose to get someone else into trouble.

The employee time clock is a great time s

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

aver, because it allows a computer to do most of the work. However it's important to remember that no system is totally perfec

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

t. Swipe cards have been known to fail, particularly once the magnetic stripe starts to get worn. This can mean an employee's

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

Professional from academic institutions, pharmaceutical industries, health care indust

time isn't recorded. Of course there's always the human element, too - someone can simply forget to swipe his or her card. E

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

rrors like these will need to be manually fixed in the computer data.

Even with modern technology and computerization, it's st

.

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

ill necessary to keep track of the hours worked by an employee who is paid by the hour. Although there is still room for error

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

Companies that provide selfless information through particip

s to occur, the employee time clock is still ensuring that companies have an efficient way of keeping track of the hours worked

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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