Useful Advices - Business

Whether you are working at home, in the office, or in your car -- your ability to produce results with the least amount of stress, is directly affected by your physical environment. A functi

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

onal desk that is ugly can be as much of a deterrent to productivity as a beautiful desk that is not functional. I have spent over twenty years with people working in their homes, offices an

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

Examples of combination products may in

cars. One thing has become vehemently clear. Your desk can be your greatest enemy or your best friend.

Take a good look at your desk. How does it make you feel? Are you comfortable there

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

Can you do what you need to do there easily? How does it look to other people? Does it reflect the message you want to give to the world about your work and your values?

Analyze the kind

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

of activities you need or want to do at your desk. If you use a computer, an L-shape desk is usually the best option. Use the short end of the “L” for your computer, and the long end for d

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

Combination pro

esk accessories, your telephone, and spreading out papers while you are working.

One of the major detractors to an effective and attractive desk are those pesky scraps of paper, which seem t

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

proliferate in your absence and sometimes in your presence! In my experience, an important component of any desk is space for files. I prefer two file drawers in my desk – one for current pr

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

jects and another for reference materials I use frequently. If you are an “out of sight, out of mind” person, you may prefer a file holder that sits on top of your desk. You can use Post- it

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

Flags with colored bars for easy-to-use color-coded labels.

Do you get lots of phone calls? If so, it is important to develop a systematic way to record all those messages. In our office,

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

we leave an open 6” x 9” spiral-bound notebook by the telephone to jot them down. The top of each page is dated, and we put the initials of the person responsible for responding to the call i

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

the left-hand column. When the action is completed, the initials are crossed out. Any pending issues are flagged with a Post-it? Flag – a different color for each person. The flag dispens

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

Following aspects would a

rs are attached to the side of the telephone.

Do you spend lots of time talking on the telephone? If so, what do you need? Is your source of phone numbers – electronic or paper -- easily a

dd to the challenges in developing combination products:

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

cessible? Do have a consistent way to take notes while you are talking? To make filing your telephone notes easier, keep Post-it? 4” x 6” pads nearby. Avoid putting notes from several conv

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

ersations on the same piece of paper.

The greatest desk in the world will be sabotaged without a comfortable adjustable chair and good lighting. An inspirational piece of art in your natura

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

line of vision can be a real stress reducer too!

Most people want to be able to move around in their work area, so a swivel chair on rollers is a big advantage. If there is carpeting, you

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

ill need a chair mat so the chair will roll easily.

Most desks I see are too cluttered – paper that could be filed away if you were confident you could find it when you needed it (we’ll talk

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

Professional from academic institutions, pharmaceutical industries, health care indust

more about that in future columns!), office supplies you never use, and memorabilia that has been there so long you don’t even see it!

Essential desktop supplies for most people include an “

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

In Box” for mail you haven’t looked at yet (not a place to put postponed decisions!); an “Out Box” for the things that need to go outside your office, and a “To File Box” for the papers that

.

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

eed to be filed outside the reach of your desk. Caution: Eliminate any container not designated for a specific purpose or it will soon become a catchall for unidentified objects!

My defini

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

Companies that provide selfless information through particip

ion of “organized” is very simple:

1) Does it work and
2) Do you like it? If you answer “No” to either of those questions when it comes to your desk, decide now what you can do about it

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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Finding limo services in Denver is not hard to do. The hunt for Denver limousine service is something needs time to consider and should be taken seriously.

If you are a medical device manufacturer located outside the European Union or the European Free Trade Association and wish to export into the European Market, you must follow several steps to ensure that your product is in compliance with the European Directives.

Although there are advantages to selling your own proprietary products and services, there are also drawbacks. For example, the time and investment required to produce your own book, invention, or other product could mean a long delay in receiving profits and cashflow essential to your business survival.

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