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Digg It - Tales from the Corporate Frontlines: Workplace Ethics: Reaching the Highest Standard
This article relates to the Ethics in the Workplace competency, commonly evaluated in employee surveys. It gives examples of how employees and customers consider ethical behavior and
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
sound values an integral part of your organization. This competency covers a variety of topics like customer treatment, employee professionalism, and expected/acceptable organizatio
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nal behaviors. At a high level, this competency will investigate the standards by which your employees treat your customers, co-workers, and the organization itself.
This short stor
This short stor
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
y, Workplace Ethics: Reaching the Highest Standard, is part of AlphaMeasure's compilation, Tales from the Corporate Frontlines. It provides insight into one organization's efforts to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
establish and maintain the highest possible standard of ethics in the workplace.
Anonymous Submission
When I began working at a local no-profit organization, I had little e
Anonymous Submission
When I began working at a local no-profit organization, I had little e
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
xperience with the concept of workplace ethics. My previous jobs had been in retail and health care, where I'd worked in team environments, and the companies I'd worked for weren't e
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
thics oriented. I'd seen a few memos dealing with issues like sexual harassment, but no extensive workplace ethics programs appeared to be in place. When a situation arose that invol
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
ved an ethics issue, employees turned to immediate supervisors for direction and then followed that direction.
So, I was surprised when, only two weeks into my new job, I was asked
So, I was surprised when, only two weeks into my new job, I was asked
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to join a focus group dedicated to revamping the organization's ethics program. The Human Resources department was gathering info to use in conjunction with data to be gained from an
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
upcoming employee satisfaction survey. I agreed to participate, making it clear that I had no idea what was involved, but would do my best to make the group's effort a success.
Whe
Whe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
n I arrived at the first meeting, I didn't know what to expect. The facilitator made it clear from the start that the main purpose of the group was to gain feedback about employee es
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
timation of the current workplace ethics program. He handed out an information packet containing the applicable policies as well as all the procedures currently in place. We were ask
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ed to review it all and return with our honest comments and reactions with regard to effectiveness, compatibility with our personal values, and relationship to the organizational cul
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ture. Evaluation forms were provided to help with this process. He also made it clear that all participation was completely voluntary, and we should not feel pressure to discuss any
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
issues with which we felt uncomfortable.
We were also asked to consider:
* Whether the company wide standards of conduct were strict enough
* Whether the leadership represente
We were also asked to consider:
* Whether the company wide standards of conduct were strict enough
* Whether the leadership represente
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
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
d a strong enough role model
* Whether core values such as respect and honesty were demonstrated visibly enough in the everyday operation of the organization.
It was a thorough
* Whether core values such as respect and honesty were demonstrated visibly enough in the everyday operation of the organization.
It was a thorough
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
and complete review process. Finally, it occurred to me that as a non-profit organization, we really had an obligation to be sure that we were operating within the highest possible
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ethical standards. At the end of the process, and after the results from the employee satisfaction survey were in, changes would be made as needed to ensure that we had an exceptiona
.
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
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
l workplace ethics program in place. A good thing, in my opinion, for any company that wants to strengthen its reputation and create a highly ethical workplace culture.
© 2005 Al
© 2005 Al
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
phaMeasure, Inc. - All Rights Reserved
This article may be reprinted, provided it is published in its entirety, includes the author bio information, and all links remain active.
This article may be reprinted, provided it is published in its entirety, includes the author bio information, and all links remain active.
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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