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Many business owners find themselves in the position to confront employees about their Internet use. Non-work related activities including online games, Internet shopping, stock trading,

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

Internet radio, streaming media and MP3 downloads represent the new temptations in the workplace.

When an employee connects to the Internet, your company is exposed to these four threat

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

Examples of combination products may in

:

• Productivity Threats: Just 20 minutes of recreational surfing a day can cost a company with 30 employees over $1000 per week (At $25/hr per employee)
• Legal Threats: 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.

can sue if you don't provide a work environment free of gender and minority harassment. This means taking reasonable care to block offensive Internet content.
• Network Threats: An

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

mployee can crash your network just by logging into the wrong website. Other activity like recreational surfing and downloading MP3 files can divert valuable bandwidth from critical busin

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

Combination pro

ss needs.
• Security Threats: Viruses enter networks through a variety of sources, such as web-based email, Instant Messenger file transfer, email attachments or through other files

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

directly downloaded from a website. Companies of all sizes must effectively incorporate email, Instant Messages and web traffic logs into their overall records management strategy. So

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

e companies must do this to comply with industry regulations such as Sarbanes-Oxley, Gramm-Leach-Bliley and HIPAA.

The first step is to choose the types of Internet content that will not

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

be allowed in the workplace. Keep in mind that not all employees will have the same privileges, so it is important the network management solution you choose provides a flexible configur

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

tion to suit your needs.

There are two basic types of Internet monitoring solutions: Gateway and desktop solutions. Gateway solutions are software or hardware that act as checkpoint fo

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

all Internet traffic on the network. Desktop solutions are installed on the local machine to enforce the Internet policies before the request leaves the machine. Desktop solutions work

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

Following aspects would a

well on smaller networks and gateway solutions work well on both.

The next step is to create an official company policy specifically for Internet use. It should include all Internet ac

dd to the challenges in developing combination products:

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

ivities and not just those you wish to manage. Keep in mind the document cannot account for every possible scenario on the Internet, so it is important to use broad terms with specific e

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

amples. For example, instead of stating “Political opinions are not to be posted on newsgroups,” you may wish to use “Messages originating from the company network or other company-owned

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

assets may not contain political opinions.” The second clause is much stronger because it doesn’t specify a message type or delivery system. If you have liability insurance, then be sur

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

to get their approval on all documents. In some cases they will have additional provisions that directly relate to your industry.

The most difficult step will be implementing the new p

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

Professional from academic institutions, pharmaceutical industries, health care indust

olicies. In most cases, some or all users will experience a reduction in Internet privileges. Prepare for a temporary increase in support requests as some users will be prevented from a

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

cessing some work-related content. Internet policy configuration is an on-going process that must be routinely maintained.

Soon the complaints from users will cease and production will

.

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

eturn back to normal. It is important to keep your filtering software updated and to maintain a history of Internet activity. If the time comes when you must confront an employee about

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

Companies that provide selfless information through particip

heir Internet use, you will have proof of their Internet activity and a detailed comparison to their peers. That is a much stronger case than saying “I’ve seen you 10 times looking at ….

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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Much of the business advice from male business gurus doesn’t quite cut it for women entrepreneurs. These gurus haven’t figured out how they advice is different for women. Plus, they’ve left out some parts all together!

The war on sp^am has so far been waged on two fronts: legislation to make sp^am illegal and filters that prevent sp^am reaching its destination.

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