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Negotiation is a process of trying to arrive at a mutually agreeable conclusion about something. It could be a sales situation; it could be a behavioral contract; it could be a cease fire. Neg

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

otiation is basically an agreement. What makes negotiation’s time consuming is that each party involved often has numerous needs that require some kind of guarantee of satisfaction. Until thos

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

Examples of combination products may in

needs are at least addressed in some way, there will be objections.

Objections are critically important in successful negotiations and taking into account all objections is ecological. 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.

is, it takes into account varying components of the system. Negotiations often prove a failure after the fact because one or more of the parties does not express their objections to the propos

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

d settlement. Then, after the negotiation is over, they start to feel shortchanged and don’t abide by the agreement.

In every successful negotiation it is critically important that objections

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

Combination pro

be addressed. Some people involved in the negotiation may be shy or reserved about voicing objections. The facilitator or leader must draw out objections from participants so they can be disc

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

ssed. Once out in the open, objections can be analyised and the need or concern they represent satisfied. For example, let’s say a couple is in marital counseling negotiating a behavioral cont

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

ract. The husband wants the wife to contribute her paycheck into the joint checking account but she wants to open her own checking account. She objects to putting her money into the joint chec

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

ing account. A good question to ask to understand the reason for the objection is “what would happen if you did put your money in the joint checking account?” This requires the wife to verbali

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

ze her concerns. She might say “I wouldn’t feel as though I had some of my own money to spend in my own way whenever I wanted to for whatever reason.” The negotiator might then say “If you kne

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

you could spend your money any way you wanted whenever you wanted for whatever you wanted even with the money in a joint checking account, would you then be ok with the joint checking account

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

Following aspects would a

?” The wife might ponder this and if she says yes the condition upon which the negotiation would be successful is clarified. But, if she says no that indicates there is yet another objection w

dd to the challenges in developing combination products:

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

ich has not yet been verbalized. At that point, the negotiator needs to uncover a deeper layer of objection. This is accomplished largely through asking specific questions.

This process of un

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

covering layers of objection is the ecological part of negotiation. It ensures that all parties involved or all parts of a single person’s mind have addressed every single objection. Ecologica

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

negotiation is one of the most effective means of behavior change because although we may say we want to change behaviors, for example, to quit smoking, we find it difficult or fail because t

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

here is also a part of us that does not want to change. A person who says they want to lose weight might be surprised to find there is a part of them that objects to that goal. Ecological nego

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

Professional from academic institutions, pharmaceutical industries, health care indust

iation attempts to find the reason behind not wanting to lose weight and try and satisfy that need in some other way. For example, being overweight can serve a need. In some it might be power,

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

in others it might be protection. Without discovering the need that being overweight serves and finding other ways to meet that need, there will be an objection to losing weight.

Everyone ha

.

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

needs and most all behavior is designed to meet those needs. Ecological negotiation takes this into account and recognizes that all objections are a way of saying “hey, if that happens my nee

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

Companies that provide selfless information through particip

ds won’t be met so I’m going to object.” By accepting the objection in that light and helping that need be met in other ways, the negotiator removes obstacles to a truly successful negotiation

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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Here are a couple of things that you should think about as you’re preparing for an interview with a potential employer: First of all make sure that as you prepare for the interview, you learn as much as you can in advance about the company. What are its core markets? Which customers does it target? Who are the competitors? What is the company unique selling proposition? What is management’s vision & values? What does the leadership stand for? What is the culture about? These are all things that you should study and research prior to going into your interview.

What senior executives are most concerned with: •Retention of valued employees
•Turnover
•Ethical behavior
•Customer service and satisfaction
•Global competition
•and more

Why you need to stop approaching your friends and family and learn how to generate your own leads of qualified, interested prospects.

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