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So much has been written and said about drawing a line between your home/family life and your business life. Most people would assume that you have to keep your family out of

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

your business in order to be disciplined in order to stay focused on your job and business.

Many people can tell you that in order to keep your family life from encroaching

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

Examples of combination products may in

into your business life, but in order to keep your business functioning, you have to also keep your business OUT OF YOUR FAMILY LIFE.

Yes, this means, you should have perso

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

al space too, at home.

This is important, to most of us because we have a shared space between home and family. It's easy to confuse the both of them up and start getting bo

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

th lives mingled together. For instance, your children would be asking you to help with their homework when you're in the middle of something important. Your children fall si

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

Combination pro

k and your clients are chasing after you for something - which one is more important? You'd say the deadline, huh? So would I - some time back.

But I have been in this freel

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

ancing and home-for-work business for more than half a decade now and I understand one thing now - it depends on when your clients are calling you.

If they call you during f

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

amily time, you have to tell them that you will get to it a little bit later on when you are working. The line between work and family time should NOT be blurred.

Why is thi

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

important?

Well, for one thing, if you have specific time for both your lives, you would feel more satisfied with your working arrangements. You wouldn't be disgruntled, di

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

ssatisfied or angry with your clients about taking your precious family time from you! Imagine if your work is taking up your weekdays and weekends too - wouldn't that actual

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

y defeat the purpose of working from home? You might as well NOT be working from home if you were spending more time at work (or is less available to your children and family

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

Following aspects would a

), wouldn't you agree?

So, workaholics like me - it's best to actually draw a very clear line between family life and working life - even if they are one and the same.

For

dd to the challenges in developing combination products:

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

me, as example, I work 24 hours a day, 7 days a week and 365 days a year. Yes, that's true and I have a tagline too - the freelancer that doesn't sleep. But then again, it do

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

sn't mean that I don't sleep or I don't have a personal life. I will answer queries and phone calls and emails at un-godly hours. My response rate is normally very quick. But

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

I have definite working hours.

I work from 10.00a.m. till 2p.m. and then 3.30pm. till about 5.30pm. Then after my kids go to sleep, I spend another few hours working before

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

conking out with my kids in my arms in bed…right next to my computer (my office). I tell my live-in maid that between those hours, unless it's a life and death situation, I a

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

Professional from academic institutions, pharmaceutical industries, health care indust

m not to be to interrupted. I keep to my time religiously.

During weekends, I will only attend to phone calls and emails and not do any work at all unless necessary. For mos

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

t projects, they require me to complete things for them by MONDAY, which would mean that I have to work over the weekend. But I schedule it into the Saturday and not touch an

.

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

thing for the entire Sunday! And for rush projects that requires me to work over the weekend, I would normally charge them a 'rush fee' because I don't want to encourage them

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

Companies that provide selfless information through particip

to use my weekends for work.

This is essential for a good working environment for any homepreneur. Believe you me, it will make a happier and more effective business person

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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