Main Subject - Business

Communicating is a constant in all negotiations; in all interaction for that matter. Understanding the dynamics of effective communication

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

s to settle conflict is an important aspect of managing the negotiation process. The challenge to communications during any conflict situa

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

Examples of combination products may in

tion is that listening is typically impaired. Those involved, even when they do listen, are not apt to hear what is being said. To reach a

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

accord the parties need to be able to communicate with each other. The first rule of any negotiation is to open channels of communication

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

.

Communication concepts are important to understanding human interaction.

- Learn to listen: The ability to effectively state your me

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

Combination pro

ssage is obviously important. But the ability to clearly hear the other person's message is equally important to reaching an accord. Every

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

ne should work at developing effective, interactive listening skills. When the other person is talking, you have the chance to learn somet

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

hing; if you are listening to what they are saying rather than thinking about what you are going to say.

- Learn to Observe: Observing o

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

ther people while talking enables you to make sure they are awake, alert and interested. If not, regroup and find a way to get them person

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

lly involved in the conversation. When speaking, you are responsible to make sure the others are listening. Verify this by observing the n

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

on-verbal reactions to what you say. You are looking to see if they are thinking of something else, if they are planning what next to say,

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

Following aspects would a

or if they are just asleep!

- Take Responsibility: It is important that you are being heard and understood. We all know the game of tel

dd to the challenges in developing combination products:

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

phone. Appreciate that the other person will likely have to review what was said today with others. It is your goal that he or she be able

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

to clearly restate your case as you intend it to be heard. So proactive speaking is an essential tool when negotiating.

There are simple

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

ways to keep the other person interested and attentive to you. 1. Pepper your comments with questions designed to draw them into the disc

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

ssion. By being involved in the dialogue, they will have to consider what they are saying. And when they speak, it is your turn to listen.

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

Professional from academic institutions, pharmaceutical industries, health care indust

They may reveal something of value. 2. Use silence to draw their attention. Pause before an important point you are about to make and let

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

the silence grow until they take notice. Then proceed knowing you have their attention at the moment. 3. Use questions to reinforce their

.

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

understanding of what you have said. Ask their opinion of a point you just made. If they have missed the point, restate it. You won't hav

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

Companies that provide selfless information through particip

e as good a chance to reinforce what you have said once they leave the meeting.

If you aren't clearly understood, what chance do you have

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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