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Have you ever run around all day? Not getting anything really done. You have been busy all day doing thi

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

ngs. However by the end of the day you are exhausted? You don't remember what you did that was even prod

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

Examples of combination products may in

uctive. The days get busier with stuff and you feel like you will never get caught up. At the end of the

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

day you put your head on your pillow at night. Then you start all over again the next day. Does your da

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

y lead you or you lead your day?

Have you ever known someone that is overwhelmed in life? Do you know som

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

Combination pro

eone that goes and goes? They never take a break. Have you known someone that never laughs? How about co

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

mplains of a headache all the time?

There is a way to break though the catch up game of time. Here are

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

hree ways to catch up.

1. Shake the time up. Get up an hour earlier or stay up an hour later. It feels gr

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

eat to have one hour to yourself in the morning without any interruptions. More and more people in thi

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

s generation are staying up later. The media runs late night talk shows because of it.

2. Do your work so

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

mewhere else than in your office. Do your work under a tree or by a pool depending on your weather. You

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

Following aspects would a

can work in a library or a coffee shop. Being in or by nature, opens your mind. It gives you more ways t

dd to the challenges in developing combination products:

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

o look at things in a different way. You can do this with some of your tasks. You will be more productiv

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

e than you can imagine.

3. Decrease your unproductive activities. Over three- fourths of your activities

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

nly give you about one-fourth of your results during the day. The key to success is to realize what part

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

of your day is producing results that you desire. If those results are what you want, do it again. If

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

Professional from academic institutions, pharmaceutical industries, health care indust

not, change your activities. It matters whether you are a stay at home mom or a business developer. Fin

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

d out what part of your day is productive or unproductive. It can break you or save you.

So what does y

.

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

our day look like? Is it a rush like a roller coaster? Are you tired at the end of the day? If you answe

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

Companies that provide selfless information through particip

red yes to one of these questions, it it time to shake up your day Breakthrough your day like you own 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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I believe you manage paperwork but you lead people. How do you lead? You lead by example. It starts with you and trickles down to your team. Each team member should be made to feel as if they were the CEO of the company. If you can do this effectively, your team will take care of the customer/client and patient as they would want to be cared for when they're the consumer.

Those who attempt to apply mechanical principals to managing and motivating people will find that the laws of physics seldom apply to influencing human decision making.

We are beginning to see a horrible trend in franchising with regards to franchise registration states and franchise registration renewals. What is happening is that the states are requiring certain documentation and company audits to be performed prior to franchise registration renewal.

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