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Today’s high-tech society is taking in and putting out more information than ever imaginable. Looking for an e-mail or searching for an electronic document is as big a challen

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

ge as finding our paper files, and, in spite of all the promises of the paperless office, statistics show that exactly the opposite is happening. It is projected that by 2005

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

Examples of combination products may in

here will be 50% more paper than there was in 1995! How many lunches have you missed because you were searching through files – never finding what you needed?

Applying four

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

asic principles of information management will make a big difference – whether it’s for paper or electronic files.

1. What information does the association need to keep?

2.

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

n what form do we need to keep it?

3. For how long?

4. How can we find it when we need it?

In doing so, you may need to address the following issues:

Develop Retention Gui

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

Combination pro

elines for your association. Clutter is Postponed Decisions®. Paper will continue to pile up because someone needs to make a decision about retention. Association executives

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

ften ask me how long they should keep documents. I can’t answer that for you, my advice – make a decision. Determine the answer by looking at your own past experience.

Hold

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

an Office File Clean-Out Day. Make the day fun! Wear comfortable clothes, order in lunch, give prizes - such as the “Most Progress” or “The Funniest Discovery”. Provide staff

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

with storage boxes for files that must be kept long term. Hanging files work best and use file tabs and color code files when you can. Materials used by all staff should be pu

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

in a central location. If you need additional help, consider hiring a Professional Organizer to arrange your filing day.

Choose the best tools for your situation. One of mos

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

valuable lessons I learned from my father was “Half of any job is having the right tool”. While many associations are looking at scanning as a way of coping with information

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

Following aspects would a

verload, make sure that you are really solving a problem, and not creating another. A better option may be to index your paper files with a program such as Taming the Paper T

dd to the challenges in developing combination products:

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

ger (www.thepapertiger.com). This software allows you to cross-reference files, and find them quickly with its powerfu

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

search engine.

Train your staff to automatically use The FAT System™. There are only three decisions you can make about any piece of paper: File, Act, or Toss. Make decisi

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

ons on paper as it comes in. Put papers that require action into “Action Files.” Papers you may never need, but are afraid to throw away go into Reference Files. As Referen

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

e Files become old, they become Archive Files, or can be tossed.

Continually practice “The Art of Wastebasketry®. Research shows that 80% of what we keep, we never use. Don’t

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

Professional from academic institutions, pharmaceutical industries, health care indust

make today’s mail turn into tomorrow’s pile! Ask yourself:

• Does this require action?
• Can I identify a specific use?
• Is it difficult to get again?
• Is i

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

recent enough to be useful?
• Are there legal considerations?

If the answer to all these questions is “No,” ask one final question: “What is the worst possible thing th

.

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

t would happen if I didn’t have this piece of paper?” If you can live with your answer, toss - or recycle it!

Your office is a reflection of you and your association. Project

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

Companies that provide selfless information through particip

ng an organized, uncluttered workspace will make you more productive and less stressed. You can stop losing time searching for files. In fact, you may even find time for lunch

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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This part presents somehow personal ideas and directions by which an individual, group of people if followed by government, can gain much difference in their economy, finance and business matter not only in Pakistan but also world widely...

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