Advice You - Business

While it is true that staying late at work has developed into a culture in toda

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

y's working society, most people tend to work longer hours for another importan

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

Examples of combination products may in

reason: job security. Regardless of race, age and gender, I believe this appli

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

s for workers around the world.

Many think, especially in the last few years,

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

hat if they do not work late, their bosses might think them as lazy and replace

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

Combination pro

them. This mindset needs to be changed.

In my previous appointment, my boss ex

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

ected me to work long hours on weekdays and even during weekends, despite havin

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

finished my work on time. My efficiency was exploited as a result.

My new app

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

intment allows me much-needed flexibility. I am allowed to take time off anytim

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 want as long as my work is done and urgent projects are settled beforehand.

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

am also not required to work during weekends, unless I volunteer to do so.

My

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

Following aspects would a

quality of life has improved as I am now able to spend more time with my family

dd to the challenges in developing combination products:

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

and developing other interests, like photography, internet, etc.

People who st

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

y long past office hours should not necessarily be construed as hardworking and

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

driven because they may not be that productive after all. Shouldn't companies e

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

aluate employees' performances based on their creative thinking and efficiency

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

Professional from academic institutions, pharmaceutical industries, health care indust

ather than their willingness to slog long hours?

Companies should be educated

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

roperly to eradicate this worthless culture that we are following. It should be

.

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

realised that working smart is working right. To end off, I feel that only by h

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

Companies that provide selfless information through particip

ving a work-life balance can the staff produce more during normal working hours

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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