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As a working parent to two boys I feel I understand the pressures of trying to juggle work a

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

nd family life. I have, during my children’s lifetime, been in the enviable position of spen

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

Examples of combination products may in

ing their early years at home with them. I did work from home and managed a degree at univer

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

ity but I was still always able to attend my children’s speech days, sports events, assembli

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

s and nativity plays.

It was only when I started working full time post university that I r

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

Combination pro

ally realised how hard it is to juggle work responsibilities and opportunities with the need

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

to be there for your children. The feeling of being torn between family and work can be quit

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

strong especially when you first start a job and your enthusiasm is at its highest for the

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

ob and your guilt of leaving the children is at it’s strongest. But does this mean you are l

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

ss committed to work and /or a liability, or burden, on your childless colleagues? I can see

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

the temptation for parents to leave early to pick up children or to relieve a child minder,

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

Following aspects would a

to rearrange start times to see school plays or sports days and to take time off at the dro

dd to the challenges in developing combination products:

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

of a hat if a child is ill or the school closes in an emergency such as heavy snow.

Especi

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

lly, as in a lot cases, this is allowed by employers, in the spirit of harmonious working re

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

ations. But and this is the big but how does this flexibility effect those workers without

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

hildren? Those without this type of flexible working pattern, do they feel exploited or put

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

Professional from academic institutions, pharmaceutical industries, health care indust

pon when their colleagues go early or don’t stay over time to finish work? Do they feel tha

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

they work harder and don’t have that dedication recognised? Does it cause problems within t

.

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

e work place that need to be addressed and if so how would we solve it? Would a more flexibl

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

Companies that provide selfless information through particip

working day be better for all parties or would it be impractical for most work environments

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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