Advice You - Business

Many psychologists, political negotiators and business folks and most of academia will advise to find common grou

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

nd in negotiation, discussion or debate. Often if you sit in committees for hours to put into minutes what one pe

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

Examples of combination products may in

rson could have probably done in minutes. Of course they will swear that all this BS is somehow necessary so that

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

we can all feel good about ourselves and unite in a common cause and perhaps not be too pissed off at all the tim

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

e we are wasting.

Because of all this social conditioning humans so often are running around looking for common

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

Combination pro

round. And they are told and even actually come to believe that finding agreement makes them FEEL SOOO GOOD? The

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

truth of the matter is that finding Common Ground is over rated and one must consider the over use of that term a

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

nd how manipulative wannabe psychologists use it to promote their viewpoints over another.

It is nothing more th

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

n sales, negotiation tactics or primate politics; of course they call this Master Skills of Negotiation and even

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

go so far as to label it Leadership? More like horse ship to me. Of course it must be true because it is in all t

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

e books like; "How to Deal with Hard to Deal with People" or "The Best Book on Being Assertive" or "How to Win Fr

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

Following aspects would a

iends and Influence the Rest".

A warning to you folks out there; always be wary of someone who rather than addre

dd to the challenges in developing combination products:

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

sses the issues reverts to attempting to find common ground. Because they are using manipulative tactics on you a

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

d generally they are in their best interest and not yours. You let them know that you are looking for a Win-Win s

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

ituation and find out point blank what they really want?

Personally, anyone can find common ground with someone

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

ike me, because I cover so much ground. So, you do not need to find common ground with me, just assume it. Some w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill deny the common ground ploy if pressed to answer the question; what do you really want and they will say some

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

thing like; It makes me feel good to make others feel good?

Well really that goes without saying, as Human natur

.

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

; social innate characteristics of the species and social conditioning from family to the whole of society predic

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

Companies that provide selfless information through particip

ts that. It is a given. Ask them to be upfront and stick to the subject. I hope you consider this thought in 2007

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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There is a long list of career paths that may interest those who wish to help make the world a safer place for us all. Careers in police work, fire fighting, and ambulance service may come to mind. However, there are other careers –important careers- that also play an equally pivotal role, but many of those careers are lesser known than their high profile counterparts. A fire alarm technician is one of those careers.

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