Advice You - Business

Negotiating is a hot topic these days for a good reason. It is difficult to imagine a more vi

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

tal managerial skill than the skill of negotiating. Effective managers must be superior negot

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

Examples of combination products may in

iators. Without solid negotiating abilities, managers will inevitably make serious mistakes i

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

dealing with people at all levels, both inside and outside their organizations. As negotiato

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

rs, managers must concern themselves with substantive issues and their continuing relationshi

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

Combination pro

s with people. If they push too much, they may create hard feelings and a desire to exact rev

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

enge. If they are overly concerned about getting along with others, they may lose in many sub

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

stantive areas, thereby negatively impacting upon their department and their organization.

S

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

ccessful negotiating involves trading-off between getting along with people and getting what

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

you want. All negotiators face this dilemma: “How can I get what I really desire and yet main

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

ain a friendly relationship with the other side?” Those who can achieve these seemingly contr

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

Following aspects would a

adictory objectives have mastered the art of negotiating. Negotiation is a discussion between

dd to the challenges in developing combination products:

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

two or more people with the goal of reaching an amicable agreement on issues separating the

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

arties when neither side has the power nor the desire to use its power to get its own way.

C

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

ollaborating is one of several problem-solving approaches, however collaborating looks for a

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

orkable solution and even-handedly explores the needs of the parties until they are reasonabl

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

Professional from academic institutions, pharmaceutical industries, health care indust

y satisfied. Its advantages are that both sides can win big and collectively find solutions,

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

ideas, and outcomes that go beyond the scope of the individual parties involved. Personal rel

.

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

tionships can improve rather than deteriorate. Its pitfalls are that it can be extremely time

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

Companies that provide selfless information through particip

-consuming, and that negotiators with a forcing style may interpret this approach as weakness

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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Advice You - Negotiation: Forcing vs a Comprimising Position and Stance

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