Digg It - Business

In most organisations the administration/support team, although they can be acknowledged as being important to the business, they are treated as if th

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

ey're not.

Day after day, week after week they are in the office, slogging away making sure the work gets done. Many of them are so conscientious the

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

Examples of combination products may in

y won't take time out and stay at their desks until the work is done. Not only are they integral to the running of any business, their income and the

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

way they are treated may not always reflect the importance of their role.

Jenny's Story

Jenny has worked for her current employer, for the past thre

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

years and thoroughly enjoys her role as Personal Assistant to the General Manager. They have a great working relationship. Whenever she needs time of

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

Combination pro

f to attend her children's sports days and special events, it's never an issue. If she requires the occasional afternoon or morning off to deal with p

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

ersonal matters, all she has to do is ask. Because of this attitude with her employer, she does her utmost best in her work and never thinks twice abo

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

t working overtime on the odd occasion. In fact she works twice as hard.

This is a totally different situation to Jenny's previous employer. Jenny ha

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

d been working for another organisation where her boss was 'married to the job'. Although he had a wife and family, his behaviour didn't reflect this.

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

He worked all hours of the day and night and couldn't understand why everyone else went home at 5.00 p.m. Although she did her utmost best to organis

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

him and get the work done on time, he would always ask for tasks to be done just when she was getting ready to leave for the day.

On the many occasi

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

Following aspects would a

ons when she worked back or took work home so that her boss would have what he wanted for the next morning,he never thanked her. He just assumed that'

dd to the challenges in developing combination products:

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

s what she should do. He never considered her needs. She was a single parent and therefore had major responsibilities. She had a life too. Her boss on

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

the other hand was fortunate to have a a wife who didn't work and took care of their personal life.

Prior to Jenny being in this role, there had bee

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

three other people who had worked in her position, and all three had lasted less than three months.

Jenny had enough, she left after 6 months and fo

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

und her current position. It wasn't the money that was her main issue. It was the flexibility and appreciation. Although her boss was pleasant enough,

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

Professional from academic institutions, pharmaceutical industries, health care indust

he just didn't understand that there is more to working with someone than just paying their wages.

The Final Word

When employing staff make sure th

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

y are the right fit. If you're looking for someone who can be extremely flexible in their hours and can come in early and stay late, then make sure th

.

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

at person is in the right personal situation to do that.

Employing people is a skill in itself. Keeping them happy so that they will be an important

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

Companies that provide selfless information through particip

part of your business is another story. As mentioned in prior newsletters, when you look after your people, they will look after you and your business

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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Every day millions of people let their inner fears stop them from creating the life of their dreams. No on will deny that it is scary to step out of your comfort zone, but once you challenge your fear and take action, you can attain great things.

Six Sigma implementation projects are meant for reducing wastage in business processes. However, for ensuring the success of Six Sigma implementations, it is necessary to provide adequate training to everyone involved with the implementation.

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