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Privacy issues around words such as "Personal", "Private", "For the Eyes of Department Management Only", "Privileged" and other words requesting Privacy in communi

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

cations need to be very seriously considered.

It is incumbent upon managers in business, education, and industry today, to be very sensitive and forthright in the

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

Examples of combination products may in

r communications, and in response to privacy requests regarding communications from their employees. To be less than totally forthright can result in some very un

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

savory results from disenfranchised employees.

Let's face it. Management is about decisions, and decisions as to what you do with "Private" communications can ha

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

e long ranging results. If the communications relates to discussions of harassment and/or sexual harassment, or other discrimination issues, some very difficult d

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

Combination pro

ecisions must be made. As any investigation of these matters will result in multiple persons being made aware of the situation, it is probably best for the manage

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

to stop the party divulging the information, and make them aware of the aspects of the process of investigating the claims which will likely not be supported in t

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

he concept of "privacy." Let the accuser make the choice, continue without privacy being assured, or decide not to continue with the statements being made.

While

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

the issues of privacy in discussions of harassment and sexual harassment are quite clear, there are other areas of management communications much less clear, but s

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

till problematic. Matters relating to personnel issues might be one such case. An employee complaining about the actions of another employee, might request "priv

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

cy". The manager in this case should try to find other means of substantiating the claim without divulging the identity of the complainant. If this will not be p

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

Following aspects would a

ossible, then another conversation with the complainant is indicated, in which you might indicate that a problem has been identified, but taking action on that pro

dd to the challenges in developing combination products:

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

lem will probably implicate the complainant as the one that divulged the issue. Then let the complainant decide whether "privacy" or "solving the problem" will be

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

the course of events that best suit the complainant's needs.

In many other privacy matters, the singular choice should be to honor the request for Privacy. Tota

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

ly!! Completely!!

To do less than that could take several negative paths. Certainly the employee, whose "privacy" request has been abused, will seek ways to get

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

even. Any practices of the agency or group that may be less than correct, or possibly even illegal, will make good means of getting even if the disenfranchised e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ployee chooses. If it is in a case relating to any of the forms of discrimination, including harassment and sexual harassment, then abuse of the privacy issues, c

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

an easily be considered retaliation. One article I recently read indicated that retaliation cases are some of the easiest discrimination cases to win.

As a manag

.

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

r in Business, Education or Industry, take very serious consideration as to any and all decisions you make when "privacy" is an issue on the table.

Bill Barger

B

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

Companies that provide selfless information through particip

arger Specialties LLC

Information and resources on Harassment and Sexual Harassment are available through my web site at: http://www.sexualharassmentresources.co

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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