Main Subject - Business

No one can negotiate until they understand the situation. Wherever there is conflict there is a problem to be solved.

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

This involves getting two or more people to agree on something. Problem solving is an essential skill of any effect

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

Examples of combination products may in

egotiator.

Problem solving starts with defining the problem. Overcoming a problem cannot be accomplished until the p

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

oblem has been identified. Often the issue that appears to be the problem overshadows the actual underlying cause or

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

auses of dissension. To resolve the problem the real causes of dissension must be addressed. Mediators observe close

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

Combination pro

y how each of the parties reacts to suggested solutions to identify which party has additional issues that need to be

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

brought up and addressed before a final resolution initiative will be well received.

One method of identifying ancil

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

ary issues is to start each negotiation conference or session with a casual conversation with the other side. During

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

his casual dialogue listen for personal, business, or totally unrelated issues that may hinder open communication abo

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

t the main issue. Look for indications that suggest the other person is uncomfortable with you or the group.

Once yo

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

have collected the available "intelligence" separate the issues into those that have an impact on your discussions a

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

Following aspects would a

nd those that do not. If any of the issues that are not related can be satisfied with input on your part, offer it du

dd to the challenges in developing combination products:

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

ing the casual conversation preamble to the serious negotiation. This can be anything from how to get a parking ticke

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

validated to consoling the other person on a personal situation. The goal here is to build a supportive relationship

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

with the person that transgresses the main issue.

For the issues you have uncovered that relate to the matter at han

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

, separate the "wants" from the "needs". You will want to focus on ways to satisfy the "needs" of the other parry.

P

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

Professional from academic institutions, pharmaceutical industries, health care indust

oblem solving is the meat of dispute resolution. By expanding the issues being addressed, the parties are providing t

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

e opportunity to resolve the dispute by pairing ancillary problem solutions so that both people emerge feeling a sens

.

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

of victory. Win/Win negotiating is not so much about appeasing both sides as it is about pairing needs and satisfier

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

Companies that provide selfless information through particip

so that both parties think that they have come away with more than what they had to give away to reach the agreement

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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