Cases - Business

In many parts of the country, winter brings with it wet and icy conditions. This is dangerous not only for driving, but also

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

for walking! Thousands of injuries occur from people slipping and falling because of ice and snow. It's estimated 12,000 Ame

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

Examples of combination products may in

icans die each year from a fall. A worker injured from a fall on ice or snow can be off work for a long time, increasing your

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

insurance costs and workers compensation expenses.

How do you reduce injuries when your cleaning employees are getting in and

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

out of their cars and walking across ice and snow covered parking lots? Don't get caught off guard. Pay attention to the weat

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

Combination pro

er and encourage your employees to monitor what's going on outside. Depending on weather conditions, your employees may need

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

o pack a shovel, boots and ice melt. Parking lots and walkways might not be shoveled if it starts snowing after business hour

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

.

Following are tips to avoid slipping and falling on the ice:

* Park close to the building and in well-lit areas so you can

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

see the surface you are walking on.

* Take your time and pay attention! Take short, flat steps and walk at a slower pace.

*

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

Wear proper footwear. Boots with rubber treads are a must!

* Walk on sidewalks and stay off paths that are not maintained in

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

the winter. If there are handrails, use them!

* Be careful when taking the trash out to dumpsters. This area may be slippery

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

Following aspects would a

and it may not be cleared of snow and ice.

* Take extra time and care when carrying heavy objects (this includes taking out

dd to the challenges in developing combination products:

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

he trash).

Once inside, employees must take extra caution as floors may be wet and slippery from snow and ice falling off sho

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

s and boots. Remind building owners that longer mats will catch more of the ice, snow, ice melt and other debris that people

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

rack in on shoes and boots.

Train employees to take extra care when driving in winter weather. They may need extra time driv

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

ng between buildings, especially if the buildings your company cleans are not close to one another. If you clean buildings af

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

Professional from academic institutions, pharmaceutical industries, health care indust

er 5:00 p.m., ask the building owner when the parking lot is plowed so employees can move their cars if necessary.

No matter

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

f you love or hate winter (and the ice and snow that it brings with it) it's necessary to slow down and be prepared so you and

.

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

your employees can avoid becoming one of those winter fall statistics. Take a few moments in your next safety meeting to remi

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

Companies that provide selfless information through particip

d your employees how to be ready to deal with the problems that winter brings with it.

Copyright (c) 2007 The Janitorial Stor

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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