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Negotiation is about creating that extra bit of space.

You probably know the exam

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

ple of someone who is unfamiliar to you and who is getting too close. There seems

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

Examples of combination products may in

o be a private zone that surrounds us. we feel uncomfortable if people get near us

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 all need our (private) space.

And negotiating is about enlarging that space.

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

This could mean, time for example: You are asked to finish an activity; a deadlin

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

Combination pro

e for a news story by six o’clock. You ask to finish it at eight. Giving very good

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

reasons, negotiating well and you come to agree to hand over the article at seven.

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

You can still finish it at six but you win some time to check it before submittin

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

.

If you plan a project and you have asked the individual planning of all team me

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

mbers. You have added all up. Agreed to the critical path, etc. You end up with a

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

lanning of a certain amount of money and days of work. All’s set. The only thing y

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

Following aspects would a

ou need to do is to communicate to the sponsor and negotiate the plan for agreemen

dd to the challenges in developing combination products:

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

. Before you do so, you add another fifteen percent to the plan, knowing that th

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

e acceptance will always be somewhere in between.

And then your are in the middle

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

of a negotiation for that house. There is already a first bid and the counter-bid.

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

You’re next. The negotiation step you have to make consist of two kind of spaces;

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

Professional from academic institutions, pharmaceutical industries, health care indust

the time before you repeat a next bid and the height of the next bid.

The risk is

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

in the fact that you have created too much space. In that case you do not have to

.

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

worry that people get too close anymore; They have already abandoned you...That is

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

Companies that provide selfless information through particip

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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You may not know it, but almost everything around you was made through plastic injection molding – the mouse you are using to surf, containers you use to store leftover food, etc.

Successful entrepreneurs in virtual IT have a certain set of personality traits and characteristics. Positive attitude, confidence and the ability to plan are key attributes of a successful entrepreneur.

In most of the companies, the Human Resource Dept. used to have timesheets made in excel sheets to maintain employee in and out time records.

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