Others - Writing and Speaking

While writers are experts as organizing words, I’ve discovered that organizing one of the major tools of their trade – a home office – is often an enigma! One of the major myths of organizing is that it will s

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

tifle creativity. But how creative – or profitable? – can it be to spend time looking for what you need, or rewriting something you could have “tweaked” from a previous project – but couldn’t find it?

In my ex

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

Examples of combination products may in

erience, that old saying “A place for everything in its place” is only half right. After 20 years of organizing home offices –including my own – I am confident that “everything in it’s place” all the time would

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

stifle most writers’ creativity. The stress comes, however, when you’d like to clean up the place, because company’s coming, or you’re just tired of looking at a mess, but you don’t know how – at least not so yo

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

can find it again! Creativity is often a messy process – but being able to recover from the mess when you choose to do so – is the mark of a professional.

Consider these tips to help you get started:

1. Deve

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

Combination pro

op clear understandings and guidelines with others in the household to minimize misunderstandings about your home office. If you work at home in order to be able to care for children while you work, consider or

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

anizing a part of your office to be their “office.”

2. Choose a location for your office that you like to be. Select furniture and lighting to suit your individual preferences. If possible, create an L-shape fo

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

r your desk area with filing space within reach. Consider ergonomic design to protect yourself from fatigue or even injury. Used office furniture stores can offer great bargains.

3. Clutter is postponed decisio

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

s. Apply the FAT system to every piece of paper that comes into your office: File, Act, or Toss.

4. Set up your desk so you can process mail quickly. Most people need at least three large containers within ea

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

y reach of their desk: • In - for mail you haven’t yet looked at • Out - for items that need to go someplace else • File - for items that need to be filed outside the reach of your desk Minimize unnecessary clut

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

er by eliminating containers that are not designed for a specific purpose, such as paper clips, pens and pencils, expenses to submit, etc.

5. Put wastebasket or recycling containers wherever possible – for exam

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

Following aspects would a

le, under your desk, near the filing cabinet, or next to the fax machine. Create a location for used paper which can be used for “scratch” purposes.

6. Create “Action Files” for projects you are currently work

dd to the challenges in developing combination products:

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

ng on, or things you need to do, such as pay bills, submit expense statements, update your database, etc.

7. Create “Reference Files ” for completed projects, or for information that might be useful for future

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

projects. Keep a File Index – a list of the names of your files so you won’t create a file for “automobile” when you already have one for “car.” (Check out w

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

ww.thepapertiger.com for Kiplinger’s Taming the Paper Tiger – which automatically cross-references and indexes your paper files, and guarantees you can find anything in your office in five seconds or less!)

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

8. Develop a “Just in Time Reading System.” Instead of piling up journals and magazines, scan the table of contents for articles related to your expertise. Tear them out or photocopy and file them by subject s

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

Professional from academic institutions, pharmaceutical industries, health care indust

you can find them when you actually need to use them.

9. If you need more filing space, create “Archives” in a less accessible or off-site location for files you are legally required to keep, or for files you

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

arely use. Keep a list of those files at your desk for easy reference.

10. Feeling short of space? Look up! Make good use of wall space for bookshelves or cabinets for resources such as books, audio and vide

.

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

tapes, notebooks, magazines, and office supplies.

Remember, creative minds always have more to do than the physical body can carry out. Few writers I know are short on ideas – and frequently the more paper they

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

Companies that provide selfless information through particip

have, the less they use. Continually ask yourself “What’s the worst possible thing that would happen if I didn’t have this?” If you can live with your answer, toss – or recycle it – and write happily ever after

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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“Please take down my link.” I never thought I would live to see the day that I would get an email like this, but the latest Google update has caused some people to panic. This particular person thought that his site would be penalized if he had a link coming from a site in an unrelated field. Well, following the Jagger update how should we approach linking? Should we “nuke” our reciprocal links directories altogether? Or is there a sensible way to continue linking?

There are hundreds of things that you should consider before deciding to pursue the trade project that you are aiming for.

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