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"The only unique asset that business has for gaining a sustained competitive advantage over rivals is its workforce-the skills and dedication of its employees. There is no other sustainable competitive ad

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

vantage in the modern, high-tech, global economy," said Robert B. Reich, former Secretary of Labor under President Bill Clinton and now professor of public policy at the Goldman School of Public Policy at

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

Examples of combination products may in

the University of California at Berkeley.

Managing Labor in Tough Times

The workforce is changing, and depending on what sector your business is in or what part of the country it is located in, yo

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

u may be feeling the pinch of the growing labor shortage. Recent research from the Boston College Center on Aging and Work indicates what some companies are doing and that is: intensifying recruitment and

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

reorganizing work flow so that they stay productive with fewer people. In these tougher labor times, organizations will also need to address poor work habits of their current employees to increase retent

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

Combination pro

ion and to improve quality of service and productivity.

Getting Control of the Workforce

One of the greatest challenges for your supervisors is in knowing how to deal effectively with employees who

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

have less than desirable work habits. There is even more pressure if the organization is going through change, and you are doing more with fewer people. Typical issues such as absenteeism, language issue

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

s, and dress and grooming habits can lead to poor morale for the entire team and become a real management issue.

Do these managers sound familiar to you? -Sheila stays away from dealing with issues such

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

as grooming because they seem too personal in nature. -Jeff treats negative behavior with negative behavior himself. -Rob believes there are just too many larger issues to tackle.

Do these managers sound

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

familiar to you? -Sheila stays away from dealing with issues such as grooming because they seem too personal in nature. -Jeff treats negative behavior with negative behavior himself. -Rob believes there

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

are just too many larger issues to tackle.

Do you think this isn't happening in your organization?

Of course it is. More than you probably know. A chip here, a chip there and the volume of poor wor

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

Following aspects would a

k habits adds up in terms of lost time and money to the organization and the ability to retain employees. But, these issues can be dealt with through appropriate communication so that employee self-esteem

dd to the challenges in developing combination products:

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

can be maintained.

Reich points out in a talent management article that on-the-job-training and on-the-job skills development can help retain your workforce. Your supervisors, managers and team leaders

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

may not already have the skills they need to help their employees improve their work habits.

Keys to Sustaining Competitive Advantage

One of the keys you need in sustaining a competitive advantage

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

is certainly training. Improving Work Habits is a Vital Learning training program for your supervisors to help them clearly and specifically communicate the nature of employee work problems and develop an

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

individual plan for addressing the issue. The program will enable managers to:

Recognize the difference between job performance and work habits and the skills it takes to bring the situation to a succes

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

Professional from academic institutions, pharmaceutical industries, health care indust

sful resolution.

Understand that unsatisfactory work habits must be dealt with quickly and effectively before they require disciplinary action.

Explain clearly and specifically the nature of the issues

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

with work habits by focusing on behaviors rather than attitude.

Use an action plan and ongoing reviews to help team members improve work habits and demonstrate personal accountability.

Your training par

.

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

tner can help you implement a solution that is right for your organization. The online version makes it easy to deliver the program in a blended format, saving you time off the job, but yet it trains and

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

Companies that provide selfless information through particip

reinforces the skills needed to tackle poor employee work habits.

Quote for the Week

"Training is the vehicle by which a philosophy of people potential is transformed into fact". - Cloyd S. Steinmet

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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