Advice You - Business

According to statistics one out of every five pregnant women will not return to work. Quitting abruptly after

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

childbirth could wreak havoc on your finances, your career and even your relationship with your partner.

How

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

Examples of combination products may in

can you determine if you are vulnerable to quitting your job abruptly after having your baby? Below are some

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

lements that can contribute to leaving your job:

1. You hate your job-Babies have a way of forcing true feeli

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

ngs to the surface. This means that if you hate your job now, while you are pregnant, you might find it physi

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

Combination pro

ally impossible to leave your baby to return to it afterwards. If this is the case in your life, admit it now

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

and start planning to find a new job, start your own business or take a leave of absence. Now is definitely be

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

ter than later.

2. You are a perfectionist- Being a working mother means trusting others to do things for you

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

but not necessarily like you do them. Practice letting things go around the house a little bit and delegating

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

more at home and at work. Women who insist on doing it all may end up quitting abruptly due to the stress caus

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

ed by impossibly high standards.

3. You are 100% sure that you will be returning to work-Women who refuse to

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

Following aspects would a

even allow themselves the thought of quitting are prime candidates for leaving abruptly after giving birth. Th

dd to the challenges in developing combination products:

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

s is sometimes due to feeling cheated by a short maternity leave or simply repressing true feelings about thei

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

r dual roles. Pregnancy and babies are not about certainties. It is wise to take some time and consider all op

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

ions including what you (and your partner) would do if one of you decided not to return to work.

The bottom l

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

ine is that whatever you choose will be the right decision for you as long as you are making the decision cons

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

Professional from academic institutions, pharmaceutical industries, health care indust

iously and not out of stress or unacknowledged feelings. The benefits of knowing, for the most part, what your

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

actions are going to be after the birth of your baby are numerous when you think about finances, planning at

.

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

ork and not burning future bridges.

Notes:Cigna insurance company estimates that for every woman who quits he

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

Companies that provide selfless information through particip

r job after childbirth, four return. Source: Wall Street Journal, 1998 Work & Family Column, Sue Shellenbarger

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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