Advice You - Business

Is your list of tasks and projects getting bigger by the day? It seems that your day is out of control. You kno

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

w what I mean? The phone is ringing off the hook. Your emails are piling up. Your desk is becoming a mess. Pape

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

Examples of combination products may in

rs are stacking up. You go from task to task. You are eating lunch at your desk again. You stop and think why a

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

re some people so organized in their life. They have it "controlled". What do they do so different? How do peop

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

le get organized?

Organization is actually a skill. It can be learned by anyone who has a desire to do so. You

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

Combination pro

must first take a look at you and your life. What part of your life do you want to get organized first? You ca

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

n become overwhelmed if you try to organize everything at once. It can get you discouraged and frustrated. So

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

ake one part of your life first and start organizing it. After you get one part organized, you can start organi

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

zing another part of your life. Here are 2 steps to start getting organized in your life today:

1. Make a deci

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

sion on what part of your life you want to organize. It could be your house, office, finances, or business. Jus

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

t make a decision. Then take that one area that you have decided on and break it down into small tasks. For ins

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

Following aspects would a

tance say it was your desk. What are you going to do with all the papers. File them or throw them away. Well sa

dd to the challenges in developing combination products:

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

y for instance you do not have a filing system. Get a filing system or hire someone to do it for you. Just kee

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

p breaking it down what works for you.

2. Be clear of the outcome. Sometimes when you start to get "organized"

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

in an area of your life. You may not have a clear direction for the outcome. That is why so many people fail at

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

getting organized. Most of the time people do not have a clear vision on what they want at the end. An easy wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

y to get a clear vision, is ask yourself what do I want my desk to look like at the end. Is it a system that wi

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

ll work for me? What does your filing system look like? Practice visualizing on what you want to create. How do

.

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

you do this? The simplest way is to start small.

Getting organized in life does not mean that it will always

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

Companies that provide selfless information through particip

be easy. Life does change. Practicing these two steps means taking action and being open and honest to yourself

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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