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This article relates to the human resource functions competency, commonly evaluated in employee satisfaction surveys. It deals with employee feelings with r

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

egard to the quality and implementation of the human resource role within your organization. A human resource department that is properly informed of employ

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

Examples of combination products may in

ee issues, demonstrates a high integrity level, and communicates effectively with staff and management supports a high level of confidence in the company, t

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

hroughout the workforce.

This article, Adapting Human Resource Functions, is part of AlphaMeasure's compilation, Tales from the Corporate Frontlines. It c

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

omments on the changing roles of human resource departments as companies change with the times.

Anonymous Submission

Adapting Human Resource Functi

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

Combination pro

ns

About three years ago, our company went through major downsizing. As a career human resources specialist, I was skilled at performing a number of HR fun

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

ctions, including payroll, benefits administration, and policy development and administration. At the time of downsizing, our department consisted of ten as

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

sociates, serving a worker population of roughly 600 employees.

After downsizing, we found our number cut in half. How on earth were we supposed to accompl

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

ish all of our work? We were gathered into a meeting and told that the payroll and benefits administration functions would be outsourced.

Our initial react

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

ion was one of disbelief. This was a lot to digest---big changes in a really short period of time. Our HR department had prided itself on being highly compe

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

ent. Employee satisfaction surveys had always given us the highest possible rating. Our employees valued and respected our team and its efforts. Could we ma

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

Following aspects would a

intain that same level of satisfaction, or would our jobs now consist of merely "putting out fires" correcting problems resulting from errors in the outsour

dd to the challenges in developing combination products:

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

ced work? We were worried. We understood the need for trimming the payroll to make our company more competitive, but long standing practices were deeply emb

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

edded in our psyches, and we were in shock.

In the meeting, our director told us that a team of training specialists would soon arrive, to help us manage t

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

he transition. It was a good thing, she told us. Our duties would change, but we would have more time to focus on company policy development and implementat

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

on, training and orientation of new and current workers. We would also be able to participate fully in company initiatives designed to make us more competit

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

Professional from academic institutions, pharmaceutical industries, health care indust

ive in the current economy.

As time went by, we realized that our director had been correct. In fact, the change was extremely positive. We had eliminated

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

time-consuming clerical work that utilized only a small portion of our skills, and we were given training opportunities that broadened our scope and prepare

.

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

d us to accomplish bigger and better things for the benefit of our employees, our department, and the entire company.

© 2005 AlphaMeasure, Inc. - Al

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

Companies that provide selfless information through particip

l Rights Reserved

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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