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This article relates to the Work/Life Balance competency, which investigates how your staff feels with regard to the balance between work and personal life. It explores issues

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

such as priority of family and hours on the job, also covered in this competency. Organizations that enjoy a high satisfaction level in this area will normally exhibit a low ra

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

Examples of combination products may in

te of absenteeism and experience higher employee retention. Evaluating this competency is helpful in understanding issues relating to a workforce that is commonly tardy or abse

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

t from work.

This article, Employee Ideas Achieve Work Life Balance, is part of AlphaMeasure's compilation, Tales from the Corporate Frontlines. It illustrates how one group o

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

f employees worked together to find new ways to achieve a healthy balance between the demands of work and personal or family life.

Anonymous Submission

I work as an of

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

Combination pro

ice assistant with a small business that deals in the distribution of swimming pool chemicals and supplies. Our peak periods are somewhat cyclical - busy times fall into season

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

al periods, and in the peak months it is not uncommon for our staff to spend 70 to 80 hours per week at the office.

I am a long-term employee of this company, and while the ad

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

ded hours may have upset my work life balance in the past, the extra overtime pay usually offset the inconveniences in my personal life. Until two years ago, that is. About tha

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

time, my elderly mother began to need more care, and more of my time. My children began to complain that I was too seldom available to attend their sporting and school events.

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

I mentioned this to my coworkers one day, as I sat down in the break room after my second lunchtime interruption by phone call. Although it was crazy at work, things were eve

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

worse at home, I told them. The pressure and stress were really building at this point.

I was surprised to discover that my coworkers were experiencing the same problems with

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

Following aspects would a

work life balance. "We need to have flex time", one of them said. "We should be able to decrease our working hours during the slow months, take a break and catch up with our f

dd to the challenges in developing combination products:

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

amilies and personal obligations, and just relax." Everyone agreed --- but how could it be handled? We spent some time over the next few days devising a flextime plan that allo

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

ed each of us to take a break and work a reduced schedule once the slow season arrived. We could spend the extra time away from work catching up on the family activities, house

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

hold maintenance, and general relaxation.

We discussed the plan with our supervisor, who set up a meeting with the owners of the company. It turned out that they were very pos

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

tive about our proposal, as cash flow was weak during the slow periods, and our plan would be good for business in the long run. Our employers had also recently become concerne

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

Professional from academic institutions, pharmaceutical industries, health care indust

d about morale, and having finally achieved a fully skilled and trained staff---they didn't want any of us to leave.

Last year, we began our flextime schedule. Morale improved

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

- both at home and at work, for the entire staff. We have reached a viable work life balance, and all it took was a little consultation and creative scheduling.

The busy mont

.

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

s are still harrowing, but knowing that a slowdown is ahead makes a huge difference in our morale, mental focus, and productivity ---both on and off the job.

© 2005 AlphaMe

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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Maryland payroll has some unique aspects and conditions. Some of the details and laws are set out in this article including information concerning: tax withholding and reporting; unemployment insurance taxes and reporting; wage and hour laws; and child support withholding.

There was a man who wanted to see both hell and heaven. He goes first to a land where all the people have delicious food to eat. But they have spoons longer than their arms, so they go hungry and suffer horribly. Then he goes to another place where everyone has the same wonderful food and the same long spoons. But here, they use the spoons to feed each other! This is the nature of hell and heaven, and the hair’s breadth that divides them. This parable demonstrates the difference between what people normally call ‘partnership’ and the partnership which could possibly exist in a team or an organisation of people working together.

Using project audits and reviews is recognized by most project-oriented firms as a Project Management Best Practice. Many firms, however, have not focused their audits and reviews, resulting in inconsistent protocols and inconsistently applied project management standards. This article provides some guidance on the development of those protocols, and the areas to focus during these reviews.

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