Advice You - Business

We all know how glorious those first warm days of spring feel. The trees are blooming, the birds are singing... boy, it's sure hard to keep your head out of the clouds when the skies are blue and the sun's shining brightly.

But

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

if you're outside enjoying the warm weather... who's running your business?

Spring fever is a notorious distractor for those of us trying to earn a living on our own. There's no stern manager telling us we'd better hurry back f

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

Examples of combination products may in

rom lunch. There's no one to stop us from cutting out early and cruising down to the local outdoor restaurant, slipping on our jogging shoes and heading off to the park, or venturing over to the mall for a reckless afternoon of s

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

hopping for spring fashions. So with no Big Brother to scold us, how can a freelancer keep springtime distractors from affecting productivity? Here are seven tips.

1. Shift your schedule forward or back a couple of hours.

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

If you normally sit down to work at 9 a.m., try getting up a couple of hours earlier. You can wind down at about 3 p.m. and have the afternoon/evening for yourself. Or, if you're not a morning person, ease into your day with som

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

Combination pro

e mindless activities; spend some time out of doors. Settle down to business at about 11 a.m. and work through to 7 pm. While you're doing this, remember all those poor nine-to-fivers who can't enjoy such a flexible schedule!

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

>2. Break up your work day into sections. Feeling blocked, and/or restless? Don't fight it. Sitting there for hours trying to get things accomplished when you just can't concentrate is only going to make the problem worse. S

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

pend a couple of hours doing work, and then if you need to, take some time out to clear your head. Chances are, when you return, you'll be primed for productivity. And don't forget that sometimes the greatest ideas are born when

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

the sun goes down!

3. Take a vacation. Sometimes you just have to give your body what it's asking for: a rest! If work is overwhelming you to the point that you just want to get in your car and drive away, then maybe that

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

's what you should do. Even just a few days away from the computer will do wonders for your mind, body and spirit. Take a long weekend for a scenic retreat. You'll be amazed at how much better you feel when you get back!

4. S

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

tart setting goals on paper. If you aren't doing this already, the spring season is a great time to get into the habit of setting practical goals. Having that list you can check off is a really handy way to be efficient. It's

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

Following aspects would a

sort of like being in the grocery store when you aren't in the mood to go shopping! Write down the things you need to accomplish and set a completion date (or time) for each task. Set small goals over the course of a work week,

dd to the challenges in developing combination products:

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

and bigger goals over a span of a month or two. Refer back to your list frequently, and don't forget to reward yourself for your accomplishments. You'll soon come to realize: goal-setting really helps keep you on track!

5. De

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

signate a time to check email. How many times have you set your mind to a task only to find you've lost an entire hour because you made the mistake of checking email? Email is by far the biggest time waster, especially when t

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

he weather is warm and everyone's preoccupied with frivolity. Don't give in to the temptation! Instead, designate two or three hours of your day to checking and responding to emails as well as deleting old ones that take up space

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

in your mailbox. And NO, that forward your Aunt Millie sent does not count as a work-related email!

6. Take it outside. Who says you have to sit in a dark room staring at the monitor for 9 hours straight? If the weather

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

Professional from academic institutions, pharmaceutical industries, health care indust

is balmy, why not enjoy it while at the same time keeping busy! Print out your documents, grab a beach chair and choose a nice, quiet spot where you can work quietly and enjoy the warm sunshine. Don't forget a paperweight of some

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

kind in case the wind picks up!

7. Do some spring cleaning. Sometimes, the best way to rid your mind of clutter is to rid your workspace of clutter. Grab the paper shredder, go through those old dusty files and clear awa

.

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

y all that needless paperwork you'll never use again. Organize your office so that everything you need is within reach, such as paper clips, folders, pens, pads; and of course, your Springline stapler. Junk those useless computer

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

Companies that provide selfless information through particip

files littering your computer desktop. Take a trip to Staples for a Rolodex and some stacking file holders. Once you're done reorganizing, you can finally get down to business!

Copyright 2005 Dina Giolitto. All rights reserved.

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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