Advice Pool - Self Improvement

Although we’re now well into the 21st century, it seems like the dream of the paperless office is still that: A dream. As an organization consultant who’s worked with hundred

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

s of clients, I see first hand how keeping up with the never-ending deluge of paper is one of the biggest organizing challenges that people face.

Setting up a filing system

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

Examples of combination products may in

that works for you is the best way to ensure that you can always, easily, find the information that you need. These tips and guiding principles will help you create a system

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

to keep your papers under control.

FILING SYSTEM NUTS AND BOLTS

Using the wrong products can turn the routine task of organizing papers into a nightmare. These tips will ea

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

se the pain.

A filing cabinet is almost always the best way to organize papers. You can get a huge amount of papers in a relatively small space; it is easy to put away and r

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

Combination pro

etrieve papers; your papers are kept neat and relatively safe; and it’s easy to re-arrange your papers if your needs change.

Get the best file cabinet you can afford. Only o

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

ne drawer should open at a time (to ensure that the whole thing doesn’t fall over). The drawers should extend fully and open easily. If privacy is an issue, get cabinets wit

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

h locks.

Hanging folders (Pendaflex® is the best-known brand) and manila file folders should be the basis of your filing system. Use the plastic tabs with labels to identify

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

the hanging folders.

Make it as convenient as possible for you to access your files. Place your filing cabinet(s) within reach of your desk. Put the files you use most ofte

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

n in the drawers that are easiest for you to reach. You can also use a small file box on your desk or a wall pocket for crucial files. Don’t over-stuff file folders or file c

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

abinet drawers. You should be able to easily pull out a file or drop in a piece of paper. If it’s hard to file or retrieve papers, you’ll resort to piling.

CREATING A FILING

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

Following aspects would a

SYSTEM

The key to creating an easy-to-use filing system is to sort your papers into categories that make sense to you. For most people, the best way to begin is to define a

dd to the challenges in developing combination products:

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

number of really broad categories which encompass all the papers that you need to keep. Most people can summarize their papers in 10-12 broad categories. Here are some ideas

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

to get you thinking:

Career
Finances
Home
Health
Legal documents

Depending on the amount of paper you have, each broad category can be housed in either

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

its own hanging file or its own file drawer (or section of a drawer). Label the categories clearly and put them in an order that makes sense to you.

Use the manila folders

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

to store closely-related papers (e.g., bank statements or credit card statements). Label the tab of the manila folder. Store related manila folders in one hanging folder (e.

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

Professional from academic institutions, pharmaceutical industries, health care indust

g. Finances).

If a folder is too full, determine if you can break down the category. Similarly, if you only have a few pieces of paper in a folder, see if you can logically

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

combine it with another file.

Once you get in the habit of using folders and files, you’ll be hooked. It’s important to maintain your system on a regular basis. At least onc

.

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

e a year – or whenever your files start to get full – sort through your files and toss (or archive) those that are no longer current.

TAKE ACTION!

Start with one category w

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

Companies that provide selfless information through particip

here your papers are particularly out of control, and create a new filing system to bring order to the chaos. Notice the impact it has on your productivity and peace of mind.

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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