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Many franchise agreements these days have five year franchise terms, which go through to an automatic

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

renewal period and then they go for another five years. In the past many franchise agreements were

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

Examples of combination products may in

10 to 15 to 20 years. Today business moves too fast and things change too much for a 20 year franchi

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

e agreement.

The five-year plan is nothing new. Many governments also have five-year plans which are

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

updated every five years. India for instance has a five-year plan and they have five-year plans for

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

Combination pro

any different sectors of their economy which all work together. One has to ask why the United States

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

of America does not have a decent five-year plan although we see in some sectors such as the Departme

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

t of Transportation there is actually a five-year plan which is pretty good.

Some say the United Sta

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

tes government is so large there is no way to get a five-year plan done because by the time it is don

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

the five years would be over. Yes I completely understand that complaint and it is probably true. Ne

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

vertheless we must work very hard to put forth a five-year plan and or a long-term plan that we modif

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

Following aspects would a

y every five years.

There is no reason in such a great nation should not have a 500 year plan, a 250

dd to the challenges in developing combination products:

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

year plan, a 100 year plan, a 50 year plan, a 20 year plan, ten year plan and every five years, a fiv

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

e year plan which is updated. The five-year plan works in franchising for companies with tens of tho

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

sands of outlets. In the United States we only have 50 states and 350 large cities.

We could unite

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

the whole world with five-year plans and bring everyone on the same page and have peace on Earth and

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

Professional from academic institutions, pharmaceutical industries, health care indust

rosperity through the ages which could last a thousand years. Why don't we do this? You tell me, my p

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

ersonal opinion is because humans do not plan ahead and they are not to be trusted.

Excuse my pessim

.

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

stic attitude however my observations are based on past periods and the history of the human species

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

Companies that provide selfless information through particip

and not on pie-in-the-sky spirituality oneness. If you fail to plan you are planning to fail, period

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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Although it has been around for many centuries, “wild posting” is the current rage for product offerings and events that have a need for an “in-your-face” style of promotion. You have no doubt seen wild postings as you walked through an urban area where construction site barricades are plastered with the dozens or even hundreds of posters for a rock concert. Or, you might have seen hundreds of posters for the movie “Spiderman” displayed on the side of a building. Yes, that is wild posting.

It really doesn't matter if you are preparing for your very first job interview or your hundredth - a job interview always comes with challenges. depending on the employer. One challenge you can always count on is the tough questions that employers will ask. Being prepared and knowing your own strengths and weaknesses will make the process that much easier for you - and help you to impress companies with your confidence and straightforward approach.

Organisations looking to implement change that is sustainable in the medium to long term need to have three key attributes to be successful. Based on research undertaken with dozens of businesses, this article explores the key factors that can make your improvement programme (including Lean) successful.

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