Advice You - Business

Everyone at the office thought that using the company e-mail system to share jokes and funny stories was great fun. That is, until one offended employee decided to sue his employer

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 having helped to create a hostile work environment.

Employee access to E-mail and the Internet can help to streamline communication among employees, and between employees and

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

Examples of combination products may in

ustomers. But, just like conversations or information communicated on paper, E-mail messages have the power to create significant liability issues for employers who fail to adequat

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

ely supervise how the medium is being used.

Here are just a few of the risks that unregulated access to E-mail and the Internet can create:

Loss Of Proprietary Company Information

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

Most business owners are extremely careful about the distribution of hard copies of company confidential information, and take great pains to ensure that such materials are kept s

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

Combination pro

ecure. But, an ill-intentioned employee can easily attach electronic copies of confidential materials to outgoing e-mails, all from the comfort and convenience of their own compute

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

terminal.

Wrongful Access To Proprietary Information Of Others: Just as your proprietary information can easily slip into the hands of others, so too can employees tap into the c

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

onfidential information of other companies, or misuse their copyrighted or trademarked properties. Such actions can place your company in the direct path of charges of corporate s

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

ying or of infringement of intellectual property rights.

Creation Of An Evidence Trail: As the Microsoft antitrust cases clearly demonstrate, copies of E-mails are increasingly be

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

ing subpoenaed as evidence in legal cases. Seduced by the ease of E-mail communication, many users become surprisingly candid and may openly discuss business strategies and tactics

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

that may come back to haunt your company.

Contribution To A Hostile Work Environment: As we noted above, offensive E-mail messages sent to other employees can be just as problemat

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

Following aspects would a

ic as the employee who begins every conversation with an inappropriate joke. Unmonitored use of the corporate E-mail system to circulate such material can land employers in hot wat

dd to the challenges in developing combination products:

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

r for contributing to the creation of a hostile work environment.

Potential To Alienate Customers: Employees using the company’s E-mail system to solicit for a favorite political

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

cause or to proselytize personal religious beliefs place the company in the position of unknowingly supporting those positions. Such unwitting support can jeopardize relationships

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

ith customers, prospects and vendors.

Increased Risk To Company’s Computer Infrastructure: E-mail is the distribution method of choice for computer viruses that can cripple your c

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

omputer network. Less devastating but no less taxing on your computer resources are the scores of junk e-mail messages received by employees that participate in Internet chat rooms

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

Professional from academic institutions, pharmaceutical industries, health care indust

and discussion groups that are unrelated to their work responsibilities.

Lost Productivity: Although E-mail and Internet access can improve communications, they can also serve as

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

diversions from an employee’s work responsibilities for all of the reasons noted above.

The best defense against such exposure? A policy that makes clear the restrictions on the u

.

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

e of the company’s E-mail system and Internet access can go a long way to help your employees understand the power, and the danger, inherent in E-mail communications. And, while ha

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

Companies that provide selfless information through particip

ving a company E-mail policy won’t insulate you completely from possible legal exposure, it can help to support your claims of having taken reasonable efforts to minimize such risks

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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I received this inquiry asking how I would assess this Customer-Gone-Wild episode. After I share it with you, I'll affix my answer, which I hope everyone will find useful.

The key to successful business development is about building the ability to align and adapt as a 'best fit' to the current market conditions, environment and context in which the business is operating. There are four factors for preparing for aligning a business. They are strategy, disciplined leadership, a plan and a 'can do' culture.

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