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Business is not perfect. Every employer faces internal problems that include employee differences, unmet company ex

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

pectations and lack of productivity to name just a few. Unfortunately, these problems eventually land back on the de

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

Examples of combination products may in

ks of the organization’s leadership team. No matter how distasteful handling these issues may be, they must be addr

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

ssed.

Consider the following scenarios for potential problems in your work place, problems that could be resolved w

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

ith the right management training.

Attitude-Troy is a disgruntled employee who always has a negative outlook

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

Combination pro

on job tasks. His negativity has affected his co-workers; they are beginning to adopt his pessimistic behavior. As

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

his supervisor, you are frustrated with him and the every growing string of defensive employees he’s influencing.

<

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

b>Communication-Amanda has not shown up for a few days of work. Her managers have never enforced a strict polic

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

about calling in sick so she figured she could get by a few days without showing up or contacting her supervisors.

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

She returns only when she ‘wants’ to come back to work. She thinks she will be “off the hook” if she is approached

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

bout her absence because there was never a clear absence policy to begin with.

Productivity-Spencer, a new h

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

Following aspects would a

ire, has joined a team of veteran workers. Too busy with their own duties, the experienced team fails to effectivel

dd to the challenges in developing combination products:

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

train Spencer. They felt that he would quickly pick up knowledge by simply watching them do their work. Now, one

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

f the experienced team members will be out for six weeks and you feel short handed.

Morale-You sense a lack

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

of unity with your fellow co-workers inside the company. You have a major project coming up in two weeks. You want

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

to know what things you can do to build working relationships that promote teamwork. Would company sponsored events

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

Professional from academic institutions, pharmaceutical industries, health care indust

and activities help?

Does your company experience problems similar to these? Are your company policies challenged

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

or ignored? Do your employees complain or seem unclear about their job duties? Do employees show a loss of motivat

.

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

on, simply doing their jobs without feeling responsible for the quality of work?

With the appropriate management tr

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

Companies that provide selfless information through particip

ining, supervisors and leaders are able to develop conductive environments where employees are empowered and engaged

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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Employees' writing skills — or the lack of them — substantially affect the bottom line in ways you may never have considered. This article gives some surprising examples.

Have you thought about turning your interest in Reiki into a business? If you'd like to know a little more about how to develop a Reiki practice, here are a few tips about the legal aspects of the business.

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