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If you want to start negotiations in a winning position, then you need to prepare like a tiger. That means you must pay attention to 7 crucial areas.

1. Check Whether Yo

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

u're In A Negotiating Situation. A negotiating situation exists when you are in any communication or problem-solving situation with others that can work out to your adva

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

Examples of combination products may in

ntage. If there is no advantage to you, then don't negotiate; you'll only lose. As Sun Tzu, the author of "The Art of War", said hundreds of years ago, "Engage only when it

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

is in the interests of the state; cease when it is to its detriment. Do not move unless there are advantages to be won."

2. Clarify Your Aims. Your overriding aim in

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

any negotiation is to achieve the objectives you and your constituents have set. There are other aims, such as getting a good deal and improving your relationship with the

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

Combination pro

other side. But getting what you want is tops. Always keep this aim firmly in your sights and don't stop until you get it.

3. Gather Information. Once you know you'r

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

e in a negotiating situation, you need to gather information about the other side's offer and use it to refine your own. Many negotiations come unstuck simply because one si

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

de or the other doesn't listen, or check, or take the time to clarify exactly what the other side are offering, or indeed what they themselves are offering. This means that

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

throughout a negotiation you should do tons of listening, clarifying and checking. And when it comes your turn to put over your case, you should use every skill you can must

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

er to make sure they understand.

4. Negotiate With Your Own Side. It is rare to go into a negotiation only representing yourself. Usually you negotiate as a represen

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

tative of others, your constituents. Part of your preparation for negotiations has to be spent getting the best mandate from your constituents. Aim to get the support you ne

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

Following aspects would a

ed; the trust you need; the resources you need; the understanding you need; and the freedom you need.

5. Get A BATNA. A BATNA is your Best Alternative To a Negotiate

dd to the challenges in developing combination products:

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

d Agreement and is the only certain way to be successful in negotiations. By preparing for negotiations with one party by sounding out an alternative deal with another party

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

, you get walkaway power. It means that, even if the alternative isn't quite what you want, you are still prepared to go there, if need be.

6. Prepare The Setting. T

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

here are five questions to ask yourself when preparing the setting for a negotiation. They are: Who? (ie who is to take part and do what?); Where? (ie our place or theirs?);

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

When? (ie what is the time scale?); Why? (ie what are we negotiating about?); and How? (ie how are we to present our case?).

7. Prepare Yourself Mentally. The right

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

Professional from academic institutions, pharmaceutical industries, health care indust

attitude towards negotiations is the principal difference between successful and unsuccessful negotiators. Getting into the right frame of mind before you begin should be p

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

art of your preparation plan.
* aim to be tough, business-like, alert and unyielding
* don't feel you owe them anything - don't be a bowl-beggar
* don't put 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

ourself above or below them
* stay relaxed and unhurried
* don't reveal your feelings at any point.

There is no guarantee that good preparation will lead to succe

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

Companies that provide selfless information through particip

ss in negotiations. But the chances are that poor preparation will lead to failure. Don't take that risk. Pull out all the stops to get a head start and you won't regret 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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