Main Subject - Business

This article relates to the Human Resource Functions competency, commonly evaluated in employee satisfaction surveys. It reflects one employee's satisfaction with the manner in

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

which her HR department carried out their work. This competency examines how your employees feel with regards to the quality and implementation of the human resource role within

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

Examples of combination products may in

your organization. A human resource department that is properly informed of employee issues, demonstrates a high integrity level, and communicates effectively with staff and man

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

gement should expect a high satisfaction level in this competency area.

This short story, Human Resources at Work, is part of AlphaMeasure's compilation, Tales From the Corpora

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 Frontlines. It illustrates how a competent, compassionate staff can perform their HR functions and really make a difference in the lives of employees, creating goodwill that s

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

Combination pro

reads throughout the workplace.

Anonymous Submission: Human Resources at Work

I've worked at a few different companies, and never had much interaction with human resour

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

es departments, other than hiring and benefits enrollment paperwork.

I'd like to tell you about one staff member who really made a difference in my life. Stricken with a sudden

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

and very debilitating sickness, I was completely confused about my benefits and responsibilities with regard to time off for treatment, and the coverage provided by my company-

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

aid health insurance plan. I'd rarely even been sick before, and never hospitalized.

I called work from my hospital bed to tell my manager what had happened. I asked a few ques

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

ions about my options and he told me he hadn't a clue---and offered to transfer my call to the HR department. I really didn't know what to expect. I had heard some lunchroom com

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

laints abut nasty attitude over the years, but had no reason to expect a problem in this situation. Still, I was nervous.

I needn't have been. Julie was kind, helpful, and very

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

Following aspects would a

efficient. She had a broad base of knowledge about my benefit programs and the sequence of procedures that I should follow. There were a few areas that seemed questionable, but

dd to the challenges in developing combination products:

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

he promised to get answers and get back to me. She fulfilled that promise quickly and efficiently.

Over the next few weeks, which proved to be a trying period, Julie was always

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

there for me. She helped me process paperwork, contacted the proper home office departments on my behalf, and did everything she could to minimize the stress involved in my reco

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

very. "You just concentrate on getting better, I'll take care of everything at this end", she would say to me whenever things got too confusing. She really understood my distrac

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

ion and took over for me when I wasn't thinking clearly. I'm sure there were times when another person would have lost her cool and become frustrated, but Julie never did.

I re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ently returned to work after a long rehabilitation period. I'm feeling much better now, and see and speak to Julie less often. When I think of the people who were most responsib

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

e for helping me to recover, I always think of her. She took responsibility to assist me, and did a fantastic job. She knew how to handle my issues, and was masterful at effecti

.

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 communication. Julie is an asset to our human resources department, and reached the standard that I believe all professionals in this field should strive for.

© 2005 Alpha

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

Companies that provide selfless information through particip

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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