Main Subject - Business

For a negotiation to end, decisions have to be made. Large decisions, small decisions, important decisions and mundan

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

e decisions. The process of making decisions is what advances a negotiation to its final outcome.

People naturally r

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

Examples of combination products may in

sist making decisions. This is especially true when they feel they are being pressured to commit. An effective negoti

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

tor needs to prepare others to make decisions and commit. The timing of when to seek a decision is a function of many

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

things.

Signals Indicating the Other Person is Ready to Commit:

- If the other person acknowledges your argument ha

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

Combination pro

merit, it indicates that he or she is starting to appreciate your position and may be inclined to agree or concede t

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

some degree.

- If you have made a series of points that appear to have been well received, it can be a natural mome

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

nt to continue and make a well-reasoned proposal or seek agreement on the point or points.

- After reviewing the ter

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

s of your proposal, if the other person has indicated a clear understanding of each point and not given any negative,

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

non-verbal signal that he disagrees with them, proceed to seek approval of the proposal. If he has shown discomfort o

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

some of the issues, go back and revisit those point. Ask him what he thinks of the individual point. It is not good

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

Following aspects would a

strategy to ask for a global commitment until you have sensed the smaller issues are pretty well resolved.

- Before

dd to the challenges in developing combination products:

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

asking for a decision or commitment, review the reasons the other person is agreeing to the terms and reinforce why t

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

eir decision is a good one. If you have built up a climate of mutual respect, knowing that you understand their posit

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

ion and have tried to meet their needs will help to cement the deal.

- If the other person keeps looking at his or h

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

r watch or otherwise seems pressured by time, you may want to press for a decision. If their next appointment is mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

important, personally or professionally, you may gain a last minute concession just to wrap things up.

Decisions ar

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

pivotal moments in negotiations. Treat each decision, even the small ones, with respect. Once a decision is made, re

.

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

nforce why it was a good decision. It does not hurt to intimate that you may have conceded more than expected to buil

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

Companies that provide selfless information through particip

up the other's ego a bit. You want each decision to become easier as you build toward the really important decisions

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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